Dry Eye Syndrome
Conditions
Keywords
Dry Eye
Brief summary
The objective of this study is to evaluate tolerability, safety and efficacy of Lubricin 150 µg/ml eye drops when compared to a widely used commercial 0.18% sodium hyaluronate eye drop formulation in moderate dry eye patients. Primary objectives: * Tolerability using a Visual Analogue Scale (VAS) for foreign body sensation, burning/stinging, itching, pain, stick feeling, blurred vision, and photophobia; * Treatment-emergent adverse events (TEAEs), assessed throughout the clinical investigation. Secondary objectives: * Corneal fluorescein staining (scored using the Oxford scale); * Schirmer test type I (without anaesthesia); * Symptom assessment in dry eye (SANDE); * Ocular protection index (OPI); * Tear film break-up time (TFBUT); * Best corrected distance visual acuity (BCDVA); * Slit lamp examination (SLE) (Eyelid - Meibomian glands, eyelid erythema, eyelid oedema, lashes, conjunctiva erythema, lens, iris, anterior chamber, corneal transparency, corneal neovascularisation); * Intraocular pressure (IOP); * Number of instillations of investigational medical device during the second week of the clinical investigation. All parameters will be evaluated at Screening visit-V1 (Day -7 up to day -5), baseline visit-V2 (Day 1), V3 (Day 7±1), V4 (Day 14±1) and at Final Visit follow-up-V5 (Day 21±1).
Detailed description
This study is a 2 week, randomized, double-masked, controlled, parallel group and 1 week follow-up investigation to evaluate tolerability, safety and efficacy of Lubricin (150 µg/mL) eye drops versus sodium hyaluronate (HA) 0.18% eye drops (Vismed®) in patients with moderate dry eye (DE).
Interventions
DEVICELubricin
Lubricin 150 µg/ml eye drops
DEVICESodium Hyaluronate
Sodium hyaluronate 0.18% eye drops
Sponsors
Dompé Farmaceutici S.p.A
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
The packaging used for the comparator in the present investigation aimed at ensuring a complete masking of the test IMD.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
To be checked at the screening visit (V1) within 7 days before study treatment and confirmed at baseline visit (V2): 1. Patients 18 years of age or older; 2. Patients with moderate dry eye characterized by at least one eye with signs and symptoms of moderate dry eye (grade 2 or 3 of the 2007 DEWS report); 3. Patients diagnosed with dry eye from at least 3 months (current use or recommended use of artificial tears for the treatment of Dry Eye); 4. Average VAS score for typical symptoms of Dry Eye (foreign body sensation, burning/stinging, itching, pain, stick feeling, blurred vision and photophobia) ≥ 25 mm; 5. Corneal staining score with fluorescein \> 3 using the Oxford corneal grading system in the worst performing eye; 6. Schirmer test without anaesthesia ≤ 10 mm/5 minutes in the worst performing eye; 7. Tear film break-up time (TBUT) ≤ 10 seconds in the worst performing eye; 8. Best corrected distance visual acuity (BCDVA) score ≥ 0.1 decimal units in both eyes at the time of study enrollment; 9. Only patients who satisfy all Informed Consent requirements may be included in the study. The patient and/or his/her legal representative must read, sign and date the Informed Consent document before any study-related procedures are performed. The Informed Consent form signed by patients and/or legal representative must have been approved by the Ethics Committee for the current study.
Exclusion criteria
1. Patients with a mild Dry Eye condition (severity level 1 according to the Report of the International Dry Eye Workshop -DEWS, 2007); 2. Patients with a severe Dry Eye condition (severity level 4 according to the Report of the International Dry Eye Workshop -DEWS, 2007); 3. Best corrected distance visual acuity (BCDVA) score of \< 0.1 decimal units in either eye at the time of study enrolment; 4. Evidence of an active ocular infection in either eye; 5. History or presence of ocular surface disorders not related to dry eye in either eye; 6. Use of any ocular topical medication other than the study medications for the treatment of ocular diseases including artificial tears during the study period; 7. Use of topical cyclosporine, topical corticosteroids or any other topical medication for the treatment of dry eye in either eye within 30 days of study enrolment; 8. History of any ocular surgery (including laser or refractive surgical procedures) in either eye within the 90 days before study enrolment. Ocular surgery will not be allowed during the study treatment period and elective ocular surgery procedures should not be planned during the duration of the follow-up period; 9. Presence or history of any ocular or systemic disorder or condition that might significantly hinder the efficacy of the study treatment or its evaluation, could possibly interfere with the interpretation of study results, or could be judged by the investigator to be incompatible with the study visit schedule or conduct of trail procedures (e.g. ocular trauma, progressive or degenerative corneal conditions, uveitis, systemic infection.); 10. Known hypersensitivity to one of the components of the study or procedural medications; 11. Participation in another clinical study at the same time as the present study or within 90 days of screening/baseline visit; 12. History of drug, medication or alcohol abuse or addiction; 13. Females of childbearing potential (those who are not surgically sterilized or post-menopausal for at least 1 year) are excluded from participation in the study if they meet any one of the following conditions: * are currently pregnant or, * have a positive result on the urine pregnancy test at the Screening/Baseline Visit or, * intend to become pregnant during the study treatment period or, * are breast-feeding or, * not willing to use highly effective birth control measures, such as: Hormonal contraceptives - oral, implanted, transdermal, or injected and/or mechanical barrier methods - spermicide in conjunction with a barrier such as a condom or diaphragm or an Intra Uterine Device during the entire course of and 30 days after the study treatment periods.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Visit 3 - Day 7±1, Visit 4 - Day 14±1 and Visit 5/Final visit/Follow up - Day 21±1 | A global ocular tolerability score was determined using a 100 mm Visual Analogue Scale (VAS) on which 0 meant no symptoms and 100 meant the worst possible discomfort. This evaluation was to be performed before any ophthalmic assessment at each scheduled visit. Specific ocular symptoms were measured with the VAS included: foreign body sensation, burning/stinging, itching, pain, sticky feeling, blurred vision, photophobia. The patients evaluated their symptoms using the VAS giving the value they were feeling from none to an extreme value. The VAS scale was a straight horizontal line of fixed length (100 mm). The ends were defined as the extreme limits of the parameter. Please note that Ophthalmological evaluations were performed for both eyes. Hence both the eyes - right and left - were study-eyes. |
| Treatment-emergent Adverse Events (TEAEs), Assessed Throughout the Study. | Visit 5/Final visit/Follow up - Day 21±1 | TEAEs included all AEs occurring or worsening after the first dose of the IMD. These comprise AEs during the treatment and follow-up period. For TEAE the number of events was provided. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in SANDE (Symptom Assessment in Dry Eye) - Frequency of Symptoms | Visit 3 - Day 7±1, Visit 4 - Day 14±1 and Visit 5/Final visit/Follow up - Day 21±1 | The SANDE (Symptom Assessment in Dry Eye) questionnaire was a short questionnaire to evaluate both dry eye frequency and severity by using a 100 mm VAS. For the assessment, the subjects marked on the 100 mm VAS line the point that they felt represented their perception of their current state. The VAS score was determined by measuring in millimetres from the left hand end of the line to the point that the subject marked. The SANDE scores was then evaluated for the 2 questions severity (0-100) and frequency (0-100), where 0 was the best condition and 100 marked the worst condition. Please note that ophthalmological evaluations were performed for both eyes. Hence both the eyes - right and left - were study-eyes. |
| Change From Baseline in SANDE (Symptom Assessment in Dry Eye) - Severity of Symptoms | Visit 3 - Day 7±1, Visit 4 - Day 14±1 and Visit 5/Final visit/Follow up - Day 21±1 | The SANDE (Symptom Assessment in Dry Eye) questionnaire was a short questionnaire to evaluate both dry eye severity and frequency by using a 100 mm VAS. For the assessment, the subjects marked on the 100 mm VAS line the point that they felt represented their perception of their current state. The VAS score was determined by measuring in millimetres from the left hand end of the line to the point that the subject marked. The SANDE scores were evaluated for the 2 questions severity (0-100) and frequency (0-100), where 0 was the best condition and 100 marked the worst condition. Please note that ophthalmological evaluations were performed for both eyes. Hence both the eyes - right and left - were study-eyes. |
| Change From Baseline in OPI (Ocular Protection Index) | Visit 3 - Day 7±1, Visit 4 - Day 14±1 and Visit 5/Final visit/Follow up - Day 21±1 | OPI was used to quantify the interaction between tear film break-up time and blink intervals of a subject. It was based on the idea that, even when the TBUT was normal, if the blink interval was too slow it may cause breakage of tear film due to increased evaporation. The OPI was calculated by dividing TFBUT by inter blink interval (IBI). A visual count of the number of blinks per minute was performed while the subject read the ETDRS chart. ETDRS charts had five Sloan letters on each line; the lines were of equal difficulty, and there was a geometric progression in letter size from line to line. If the IBI and TBUT was same, dividing both give a value of 1.0. If TFBUT was more than IBI, dividing both, gave a value more than 1.0, so dryness would not occur. If TFBUT was less than IBI, dividing both gave a value less than 1.0. A subject was at risk of developing dry eye if the OPI was \< 1.0; so the higher the score the better the outcome. Both eyes - right and left - were study-eyes. |
| Change From Baseline in TFBUT (Tear Film Break Up Time) | Visit 3 - Day 7±1, Visit 4 - Day 14±1 and Visit 5/Final visit/Follow up - Day 21±1 | TFBUT was measured by determining the time to tear break-up. The TFBUT test was performed after instillation of 5 µl of 2% preservative-free sodium fluorescein solution into the inferior conjunctival cul-de-sac of each eye. With the aid of a slit lamp at 10X magnification using cobalt blue illumination, the examiner monitored the integrity of the tear film, noting the time it took to form lacunae (clear spaces in the tear film) from the time that the eye was opened after the last blink. This measurement was performed within 10 seconds maximum. The TFBUT was measured twice during the first minute after the instillation of the fluorescein. If the 2 readings differed by more than 2 seconds, a third reading was taken. The TFBUT value was the average of the 2 or 3 measurements. Generally, a TFBUT value of 10-35 seconds was considered normal. A value of less than 10 seconds was usually suspicious and may indicate tear film instability. Both the eyes - right and left - were study-eyes. |
| Change From Baseline in Corneal Fluorescein Surface Staining (Oxford Score) | Visit 3 - Day 7±1, Visit 4 - Day 14±1 and Visit 5/Final visit/Follow up - Day 21±1 | The corneal fluorescein staining was graded by using the Oxford scheme to assess cornea and conjunctiva epithelium damage. The Oxford grading scale divides corneal staining into six groups according to severity from 0 (absent) to 5 (severe). The examiner compared the overall appearance of the patient's corneal staining with a reference figure, simulating the pattern of staining encountered in dry eye disease. No attempt was made to count the dots or to assess the position or confluence of the dots. The examiner selected the appropriate grade that best represented the state of corneal staining. The grading system recommended by NEI divides the cornea into five zones (central, superior, temporal, nasal, and inferior) and for each zone, the severity of corneal fluorescein staining is graded on a scale from 0 to 3 based on reference figures. Therefore, the maximum score (worst outcome) was 15, the minimum (best outcome) was 0. Please note: both the eyes, right & left, were study-eyes. |
| Change From Baseline in Slit Lamp Examination (SLE) | Visit 3 - Day 7±1, Visit 4 - Day 14±1 and Visit 5/Final visit/Follow up - Day 21±1 | The Slit Lamp Examination was used to examine the structures of the eye (eyelids, lashes, conjunctiva, cornea, lens, iris and anterior chamber) according to different scales: Eyelid - Meibomian glands (from 0-none to 3-severe), Eyelid - Erythema (from 0-none to 4-very severe), Eyelid - Oedema (from 0-none to 4-very severe), Lashes (0-normal 1-abnormal), Conjunctiva - Erythema (from 0-none to 3-severe), Conjunctiva - Oedema (from 0-none to 4-very severe), Lens (from 0-no opacification to 3-severe lens opacification), Iris (0-normal 1-abnormal), Anterior chamber inflammation (from 0-none to 3-severe), Cornea transparency (from 0-completely transparent to 4-complete cornea opacity), Cornea neovascularization (0-absence of neovascularization to 4-neovascularization between 270° and 360°). The higher the score the worse the outcome. There was not a total score. Please note: ophthalmological evaluations were performed for both eyes. Hence both eyes - right and left - were study-eyes. |
| Change From Baseline in IOP (Intraocular Pressure) | Visit 3 - Day 7±1, Visit 4 - Day 14±1 and Visit 5/Final visit/Follow up - Day 21±1 | The intraocular pressure (IOP) of the eye was determined by the balance between the amount of aqueous humor that the eye marked and the ease with which it leaved the eye. IOP was performed using Goldmann applanation tonometry after the instillation of a topical anaesthetic. The Goldmann applanation tonometer measured the force necessary to flatten a corneal area of 3.06 mm diameter. At this diameter, the resistance of the cornea to flattening was counterbalanced by the capillary attraction of the tear film meniscus for the tonometer head. The IOP (in mm Hg) equals the flattening force (in grams) multiplied by 10. IOP was measured in both eyes after completion of all other SLEs to avoid potential interference with the other evaluations. Both eyes were tested. Normal eye pressure was between 10 to 21 mm Hg. High intraocular pressure was greater than 21 mm Hg. Please note: ophthalmological evaluations were performed for both eyes. Hence both eyes - right and left - were study-eyes. |
| Number of Instillations of IMD During the Second Week of the Clinical Investigation | from Visit 3 - Day 7±1 to Visit 4 - Day 14±1 | The number of daily instillations of test and comparator IMD from from Visit 3 - Day 7±1 to Visit 4 - Day 14±1 |
| Change From Baseline in BCDVA (Best-corrected Distance Visual Acuity) - ETDRS Score | Visit 3 - Day 7±1, Visit 4 - Day 14±1 and Visit 5/Final visit/Follow up - Day 21±1 | BCDVA was determined by careful refraction according to the standard protocol for refraction. Chart 1 was used for testing the VA of the right eye; Chart 2 for the left eye; and Chart R for refraction only. Retroilluminated standard Early Treatment of Diabetic Retinopathy Study (ETDRS) charts were used. They had 5 Sloan letters on each line of equal difficulty, and there was a geometric progression in letter size from line to line.VAS awarded one point for every letter correctly guessed. A distance of 4 meters (m) was required between the subject's eyes and the VA chart. When a subject cannot read at least 20 letters on the chart at 4 m, the subject was tested at 1 m. If 20 or more letters were read at 4 m, the VAS for that eye was recorded as the no of letters correct at 4 m plus 30. Otherwise, the VAS was the no of letters read correctly at 1 m plus the no read at 4 m. The higher the score the better the outcome. Both eyes - right and left - were study-eyes. |
| Change From Baseline in Schirmer Test I (Without Anaesthesia) | Visit 3 - Day 7±1, Visit 4 - Day 14±1 and Visit 5/Final visit/Follow up - Day 21±1 | The Schirmer test type I (without anaesthesia) was performed to measure aqueous tear secretion prior to the instillation of any dilating or anaesthetic eye drops.The rounded bent end of a sterile strip was inserted into the lower conjunctival sac over the temporal one-third of the lower eyelid margin. After 5 minutes had elapsed, the Schirmers test strip was removed and the length of the tear absorption on the strip was measured (millimeters/5 minutes). Changes from baseline in values of Schirmer's test type I were summarised by eye and evaluation visit, and stratified by severity level. The longer the wetted length, the healthier the status of the eye. Please note that Ophthalmological evaluations were performed for both eyes. Hence both the eyes - right and left - were study-eyes. |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lubricin 150 μg/ml (FAS) Lubricin 150 μg/ml eye drops solution
The test investigational device as well as the comparator, was instilled b.i.d. (two times a day), one drop into each eye, from day 1 to day 7±1 and, then, from 2 to 6 times a day as needed (i.e. prn), one drop into each eye, from day 7±1 to day 14±1.
After the end of the treatment period, all the subjects used Vismed® 0.18% b.i.d. every 8±1 h, one drop into each eye, from day 14±1 to day 21±1.
Before the start of the treatment (from day -6/-4 to day -1), the subjects were allowed to use only Nebul®, NaCl 0.9% ocular solution q.i.d. every 4±1 h, one drop into each eye.
Lubricin: Lubricin 150 µg/ml eye drops | 19 |
| Sodium Hyaluronate 0.18% (FAS) Vismed®, 0.18% sodium hyaluronate eye drops
The comparator, as well as the test investigational device, was instilled b.i.d. (two times a day), one drop into each eye, from day 1 to day 7±1 and, then, from 2 to 6 times a day as needed (i.e. prn), one drop into each eye, from day 7±1 to day 14±1.
After the end of the treatment period, all the subjects used Vismed® 0.18% b.i.d. every 8±1 h, one drop into each eye, from day 14±1 to day 21±1.
Before the start of the treatment (from day -6/-4 to day -1), the subjects were allowed to use only Nebul®, NaCl 0.9% ocular solution q.i.d. every 4±1 h, one drop into each eye.
Sodium Hyaluronate: Sodium hyaluronate 0.18% eye drops | 20 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Total | Sodium Hyaluronate 0.18% (FAS) | Lubricin 150 μg/ml (FAS) |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 9 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants | 11 Participants | 17 Participants |
| Age, Continuous | 56.8 years STANDARD_DEVIATION 12.5 | 61.8 years STANDARD_DEVIATION 13.3 | 51.9 years STANDARD_DEVIATION 11.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 38 Participants | 20 Participants | 18 Participants |
| Region of Enrollment Italy | 39 participants | 20 participants | 19 participants |
| Sex: Female, Male Female | 36 Participants | 18 Participants | 18 Participants |
| Sex: Female, Male Male | 3 Participants | 2 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 2 / 20 | 1 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS)
A global ocular tolerability score was determined using a 100 mm Visual Analogue Scale (VAS) on which 0 meant no symptoms and 100 meant the worst possible discomfort. This evaluation was to be performed before any ophthalmic assessment at each scheduled visit. Specific ocular symptoms were measured with the VAS included: foreign body sensation, burning/stinging, itching, pain, sticky feeling, blurred vision, photophobia. The patients evaluated their symptoms using the VAS giving the value they were feeling from none to an extreme value. The VAS scale was a straight horizontal line of fixed length (100 mm). The ends were defined as the extreme limits of the parameter. Please note that Ophthalmological evaluations were performed for both eyes. Hence both the eyes - right and left - were study-eyes.
Time frame: Visit 3 - Day 7±1, Visit 4 - Day 14±1 and Visit 5/Final visit/Follow up - Day 21±1
Population: The Full Analysis Set (FAS) population included all enrolled subjects, who received at least one dose of the IMD (Lubricin or Vismed®) during the treatment phase. This analysis set was used for the efficacy analysis. Data in the FAS are analyzed for each eye, left and right respectively. Each eye contributes to the analysis without having defined a study eye.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Burning /Stinging - Right eye - Day 14±1 | -37.9 mm | Standard Deviation 27.2 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Blurred vision - Left eye - Day 21±1 | -37.7 mm | Standard Deviation 29.4 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Photophobia - Right eye - Day 21±1 | -39.1 mm | Standard Deviation 28.3 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Foreign body sensation - Left eye - Day 7±1 | -29.3 mm | Standard Deviation 27.1 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Foreign body sensation - Right eye - Day 7±1 | -28.4 mm | Standard Deviation 29 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Foreign body sensation - Left eye - Day 14±1 | -38.9 mm | Standard Deviation 23.8 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Foreign body sensation - Right eye - Day 14±1 | -35.9 mm | Standard Deviation 23.1 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Foreign body sensation - Left eye - Day 21±1 | -32.7 mm | Standard Deviation 29.4 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Foreign body sensation - Right eye - Day 21±1 | -32.3 mm | Standard Deviation 26.3 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Burning /Stinging - Left eye - Day 7±1 | -32.1 mm | Standard Deviation 30.9 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Burning /Stinging - Right eye - Day 7±1 | -29.2 mm | Standard Deviation 28.7 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Burning /Stinging - Left eye - Day 14±1 | -41.9 mm | Standard Deviation 26.8 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Sticky feeling - Right eye - Day 7±1 | -33.1 mm | Standard Deviation 27.8 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Burning /Stinging - Left eye - Day 21±1 | -41.2 mm | Standard Deviation 27.6 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Burning /Stinging - Right eye - Day 21±1 | -35.7 mm | Standard Deviation 25.8 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Itching - Left eye - Day 7±1 | -26.2 mm | Standard Deviation 30.6 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Itching - Right eye - Day 7±1 | -18.4 mm | Standard Deviation 22.3 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Itching - Left eye - Day 14±1 | -22.5 mm | Standard Deviation 21.7 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Itching - Right eye - Day 14±1 | -22.7 mm | Standard Deviation 23.2 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Itching - Left eye - Day 21±1 | -21.7 mm | Standard Deviation 20.2 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Itching - Right eye - Day 21±1 | -21.9 mm | Standard Deviation 23.3 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Pain - Left eye - Day 7±1 | -10.1 mm | Standard Deviation 15.2 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Pain - Right eye - Day 7±1 | -7.4 mm | Standard Deviation 17.3 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Pain - Left eye - Day 14±1 | -12.4 mm | Standard Deviation 15.6 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Pain - Right eye - Day 14±1 | -11.3 mm | Standard Deviation 16.6 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Pain - Left eye - Day 21±1 | -12.3 mm | Standard Deviation 16.9 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Pain - Right eye - Day 21±1 | -14.3 mm | Standard Deviation 15.8 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Sticky feeling - Left eye - Day 7±1 | -28.5 mm | Standard Deviation 28 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Sticky feeling - Left eye - Day 14±1 | -33.1 mm | Standard Deviation 30.5 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Sticky feeling - Right eye - Day 14±1 | -35.9 mm | Standard Deviation 26.5 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Sticky feeling - Left eye - Day 21±1 | -31.7 mm | Standard Deviation 30.8 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Sticky feeling - Right eye - Day 21±1 | -37.3 mm | Standard Deviation 26.5 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Blurred vision - Left eye - Day 7±1 | -36.1 mm | Standard Deviation 30.4 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Blurred vision - Right eye - Day 7±1 | -28.4 mm | Standard Deviation 31.6 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Blurred vision - Left eye - Day 14±1 | -34.9 mm | Standard Deviation 25.7 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Blurred vision - Right eye - Day 14±1 | -27.7 mm | Standard Deviation 24.9 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Blurred vision - Right eye - Day 21±1 | -33.3 mm | Standard Deviation 26.1 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Photophobia - Left eye - Day 7±1 | -34.9 mm | Standard Deviation 33 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Photophobia - Right eye - Day 7±1 | -35.2 mm | Standard Deviation 29.9 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Photophobia - Left eye - Day 14±1 | -37.0 mm | Standard Deviation 30 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Photophobia - Right eye - Day 14±1 | -38.6 mm | Standard Deviation 27.2 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Photophobia - Left eye - Day 21 ±1 | -42.2 mm | Standard Deviation 34.2 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Total - Left eye - Day 7±1 | -189.1 mm | Standard Deviation 119.1 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Total - Right eye - Day 7±1 | -179.9 mm | Standard Deviation 115.9 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Total - Left eye - Day 14±1 | -220.6 mm | Standard Deviation 121.1 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Total - Right eye - Day 14±1 | -209.9 mm | Standard Deviation 112.4 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Total - Left eye - Day 21±1 | -219.5 mm | Standard Deviation 137.7 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Total - Right eye - Day 21±1 | -213.9 mm | Standard Deviation 119.9 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Photophobia - Right eye - Day 21±1 | -32.1 mm | Standard Deviation 27.6 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Sticky feeling - Right eye - Day 14±1 | -20.1 mm | Standard Deviation 19.3 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Sticky feeling - Left eye - Day 21±1 | -20.2 mm | Standard Deviation 26.5 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Pain - Right eye - Day 14±1 | -24.9 mm | Standard Deviation 27.3 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Blurred vision - Right eye - Day 21±1 | -33.1 mm | Standard Deviation 24.9 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Total - Left eye - Day 21±1 | -191.1 mm | Standard Deviation 127.4 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Pain - Left eye - Day 21±1 | -26.6 mm | Standard Deviation 24 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Foreign body sensation - Left eye - Day 7±1 | -16.6 mm | Standard Deviation 24.4 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Total - Left eye - Day 14±1 | -187.0 mm | Standard Deviation 115.3 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Foreign body sensation - Right eye - Day 7±1 | -20.7 mm | Standard Deviation 22.4 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Pain - Right eye - Day 21±1 | -25.7 mm | Standard Deviation 26.7 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Foreign body sensation - Left eye - Day 14±1 | -23.6 mm | Standard Deviation 25.6 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Photophobia - Left eye - Day 7±1 | -26.5 mm | Standard Deviation 26.3 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Foreign body sensation - Right eye - Day 14±1 | -24.2 mm | Standard Deviation 23.1 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Sticky feeling - Left eye - Day 7±1 | -17.1 mm | Standard Deviation 25.3 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Foreign body sensation - Left eye - Day 21±1 | -23.0 mm | Standard Deviation 23.7 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Sticky feeling - Right eye - Day 7±1 | -18.0 mm | Standard Deviation 21.4 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Foreign body sensation - Right eye - Day 21±1 | -23.3 mm | Standard Deviation 21.3 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Total - Left eye - Day 7±1 | -153.5 mm | Standard Deviation 129.1 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Burning /Stinging - Left eye - Day 7±1 | -23.5 mm | Standard Deviation 21.3 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Sticky feeling - Left eye - Day 14±1 | -21.9 mm | Standard Deviation 23.6 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Burning /Stinging - Right eye - Day 7±1 | -27.3 mm | Standard Deviation 22.1 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Photophobia - Right eye - Day 7±1 | -28.0 mm | Standard Deviation 25 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Burning /Stinging - Left eye - Day 14±1 | -31.0 mm | Standard Deviation 24.4 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Total - Right eye - Day 21±1 | -195.6 mm | Standard Deviation 115.9 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Burning /Stinging - Right eye - Day 14±1 | -33.8 mm | Standard Deviation 25.3 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Photophobia - Left eye - Day 14±1 | -29.3 mm | Standard Deviation 27 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Burning /Stinging - Left eye - Day 21±1 | -29.5 mm | Standard Deviation 24.6 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Sticky feeling - Right eye - Day 21±1 | -19.4 mm | Standard Deviation 22.4 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Burning /Stinging - Right eye - Day 21±1 | -32.9 mm | Standard Deviation 24.6 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Total - Right eye - Day 7±1 | -168.7 mm | Standard Deviation 117.3 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Itching - Left eye - Day 7±1 | -18.2 mm | Standard Deviation 22.4 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Blurred vision - Left eye - Day 7±1 | -22.7 mm | Standard Deviation 21.8 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Itching - Right eye - Day 7±1 | -25.3 mm | Standard Deviation 27.2 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Photophobia - Right eye - Day 14±1 | -30.5 mm | Standard Deviation 23.6 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Itching - Left eye - Day 14±1 | -31.3 mm | Standard Deviation 27 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Blurred vision - Right eye - Day 7±1 | -27.9 mm | Standard Deviation 26.2 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Itching - Right eye - Day 14±1 | -28.5 mm | Standard Deviation 26.1 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Total - Right eye - Day 14±1 | -190.9 mm | Standard Deviation 99.7 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Itching - Left eye - Day 21±1 | -32.5 mm | Standard Deviation 24.6 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Blurred vision - Left eye - Day 14±1 | -27.2 mm | Standard Deviation 19.5 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Itching - Right eye - Day 21±1 | -29.2 mm | Standard Deviation 23.4 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Photophobia - Left eye - Day 21 ±1 | -30.8 mm | Standard Deviation 28 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Pain - Left eye - Day 7±1 | -21.0 mm | Standard Deviation 29.2 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Blurred vision - Right eye - Day 14±1 | -29.0 mm | Standard Deviation 22.5 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Pain - Right eye - Day 7±1 | -21.6 mm | Standard Deviation 26.4 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Blurred vision - Left eye - Day 21±1 | -28.7 mm | Standard Deviation 22.6 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS) | Pain - Left eye - Day 14±1 | -22.9 mm | Standard Deviation 26.1 |
Comparison: Analysis of variance for repeated measures on Foreign body sensation - Left eyep-value: 0.012995% CI: [2.41, 14.72]repeated measures ANOVA
Comparison: Analysis of variance for repeated measures on Foreign body sensation - Right eyep-value: 0.007795% CI: [1.7, 13.45]repeated measures ANOVA
Comparison: Analysis of variance for repeated measures on Burning/ Stinging - Left eyep-value: 0.158995% CI: [-1.64, 9.62]repeated measures ANOVA
Comparison: Analysis of variance for repeated measures on Burning/ Stinging - Right eyep-value: 0.316795% CI: [-2.78, 8.35]repeated measures ANOVA
Comparison: Analysis of variance for repeated measures on Itching - Left eyep-value: 0.524395% CI: [-7.64, 3.96]repeated measures ANOVA
Comparison: Analysis of variance for repeated measures on Itching - Right eyep-value: 0.671495% CI: [-4.45, 6.82]repeated measures ANOVA
Comparison: Analysis of variance for repeated measures on Pain - Left eyep-value: 0.082895% CI: [-8.31, 0.53]repeated measures ANOVA
Comparison: Analysis of variance for repeated measures on Pain - Right eyep-value: 0.782395% CI: [-4.77, 3.62]repeated measures ANOVA
Comparison: Analysis of variance for repeated measures on Sticky feeling - Left eyep-value: 0.043295% CI: [0.16, 9.7]repeated measures ANOVA
Comparison: Analysis of variance for repeated measures on Sticky feeling - Right eyep-value: 0.008895% CI: [1.7, 11]repeated measures ANOVA
Comparison: Analysis of variance for repeated measures on Blurred vision - Left eyep-value: 0.001395% CI: [3.9, 14.66]repeated measures ANOVA
Comparison: Analysis of variance for repeated measures on Blurred vision - Right eyep-value: 0.0062995% CI: [-0.3, 10.92]repeated measures ANOVA
Comparison: Analysis of variance for repeated measures on Photophobia - Left eyep-value: 0.00295% CI: [3.89, 15.95]repeated measures ANOVA
Comparison: Analysis of variance for repeated measures on Photophobia - Right eyep-value: 0.011195% CI: [1.93, 13.97]repeated measures ANOVA
Comparison: Analysis of variance for repeated measures on Total score ocular tolerability - Left eyep-value: 0.044895% CI: [0.78, 62.56]repeated measures ANOVA
Comparison: Analysis of variance for repeated measures on Total score ocular tolerability - Right eyep-value: 0.083495% CI: [-3.66, 56.37]repeated measures ANOVA
Primary
Treatment-emergent Adverse Events (TEAEs), Assessed Throughout the Study.
TEAEs included all AEs occurring or worsening after the first dose of the IMD. These comprise AEs during the treatment and follow-up period. For TEAE the number of events was provided.
Time frame: Visit 5/Final visit/Follow up - Day 21±1
Population: The Safety population (SAF)included all subjects who receive at least one dose of the IMDs (Lubricin or Vismed®).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lubricin 150 μg/ml (FAS) | Treatment-emergent Adverse Events (TEAEs), Assessed Throughout the Study. | All TEAEs | 3 number of events |
| Lubricin 150 μg/ml (FAS) | Treatment-emergent Adverse Events (TEAEs), Assessed Throughout the Study. | TEAEs - Related to treatment | 0 number of events |
| Lubricin 150 μg/ml (FAS) | Treatment-emergent Adverse Events (TEAEs), Assessed Throughout the Study. | TEAEs - Not related to treatment | 3 number of events |
| Lubricin 150 μg/ml (FAS) | Treatment-emergent Adverse Events (TEAEs), Assessed Throughout the Study. | TEAEs - Mild | 3 number of events |
| Lubricin 150 μg/ml (FAS) | Treatment-emergent Adverse Events (TEAEs), Assessed Throughout the Study. | TEAEs - Moderate | 0 number of events |
| Lubricin 150 μg/ml (FAS) | Treatment-emergent Adverse Events (TEAEs), Assessed Throughout the Study. | TEAEs - Severe | 0 number of events |
| Lubricin 150 μg/ml (FAS) | Treatment-emergent Adverse Events (TEAEs), Assessed Throughout the Study. | Serious TEAEs | 0 number of events |
| Lubricin 150 μg/ml (FAS) | Treatment-emergent Adverse Events (TEAEs), Assessed Throughout the Study. | TEAEs - Leading to discontinuation | 0 number of events |
| Sodium Hyaluronate 0.18% (FAS) | Treatment-emergent Adverse Events (TEAEs), Assessed Throughout the Study. | TEAEs - Leading to discontinuation | 0 number of events |
| Sodium Hyaluronate 0.18% (FAS) | Treatment-emergent Adverse Events (TEAEs), Assessed Throughout the Study. | All TEAEs | 2 number of events |
| Sodium Hyaluronate 0.18% (FAS) | Treatment-emergent Adverse Events (TEAEs), Assessed Throughout the Study. | TEAEs - Moderate | 0 number of events |
| Sodium Hyaluronate 0.18% (FAS) | Treatment-emergent Adverse Events (TEAEs), Assessed Throughout the Study. | TEAEs - Related to treatment | 0 number of events |
| Sodium Hyaluronate 0.18% (FAS) | Treatment-emergent Adverse Events (TEAEs), Assessed Throughout the Study. | Serious TEAEs | 0 number of events |
| Sodium Hyaluronate 0.18% (FAS) | Treatment-emergent Adverse Events (TEAEs), Assessed Throughout the Study. | TEAEs - Not related to treatment | 2 number of events |
| Sodium Hyaluronate 0.18% (FAS) | Treatment-emergent Adverse Events (TEAEs), Assessed Throughout the Study. | TEAEs - Severe | 0 number of events |
| Sodium Hyaluronate 0.18% (FAS) | Treatment-emergent Adverse Events (TEAEs), Assessed Throughout the Study. | TEAEs - Mild | 2 number of events |
Secondary
Change From Baseline in BCDVA (Best-corrected Distance Visual Acuity) - ETDRS Score
BCDVA was determined by careful refraction according to the standard protocol for refraction. Chart 1 was used for testing the VA of the right eye; Chart 2 for the left eye; and Chart R for refraction only. Retroilluminated standard Early Treatment of Diabetic Retinopathy Study (ETDRS) charts were used. They had 5 Sloan letters on each line of equal difficulty, and there was a geometric progression in letter size from line to line.VAS awarded one point for every letter correctly guessed. A distance of 4 meters (m) was required between the subject's eyes and the VA chart. When a subject cannot read at least 20 letters on the chart at 4 m, the subject was tested at 1 m. If 20 or more letters were read at 4 m, the VAS for that eye was recorded as the no of letters correct at 4 m plus 30. Otherwise, the VAS was the no of letters read correctly at 1 m plus the no read at 4 m. The higher the score the better the outcome. Both eyes - right and left - were study-eyes.
Time frame: Visit 3 - Day 7±1, Visit 4 - Day 14±1 and Visit 5/Final visit/Follow up - Day 21±1
Population: The Full Analysis Set (FAS) population included all enrolled subjects, who received at least one dose of the IMD (Lubricin or Vismed®) during the treatment phase. This analysis set was used for the efficacy analysis. Data in the FAS are analyzed for each eye, left and right respectively. Each eye contributes to the analysis without having defined a study eye.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lubricin 150 μg/ml (FAS) | Change From Baseline in BCDVA (Best-corrected Distance Visual Acuity) - ETDRS Score | Left eye - Day 7±1 | 0.2 score on a scale | Standard Deviation 0.9 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in BCDVA (Best-corrected Distance Visual Acuity) - ETDRS Score | Right eye - Day 7±1 | 0.3 score on a scale | Standard Deviation 0.6 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in BCDVA (Best-corrected Distance Visual Acuity) - ETDRS Score | Left eye - Day 14±1 | -1.7 score on a scale | Standard Deviation 7.8 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in BCDVA (Best-corrected Distance Visual Acuity) - ETDRS Score | Right eye - Day 14±1 | -1.0 score on a scale | Standard Deviation 8 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in BCDVA (Best-corrected Distance Visual Acuity) - ETDRS Score | Left eye - Day 21±1 | 1.1 score on a scale | Standard Deviation 1.8 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in BCDVA (Best-corrected Distance Visual Acuity) - ETDRS Score | Right eye - Day 21±1 | 0.9 score on a scale | Standard Deviation 2.2 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in BCDVA (Best-corrected Distance Visual Acuity) - ETDRS Score | Left eye - Day 21±1 | -0.1 score on a scale | Standard Deviation 1.2 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in BCDVA (Best-corrected Distance Visual Acuity) - ETDRS Score | Left eye - Day 7±1 | -0.1 score on a scale | Standard Deviation 0.3 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in BCDVA (Best-corrected Distance Visual Acuity) - ETDRS Score | Right eye - Day 14±1 | 0.2 score on a scale | Standard Deviation 1 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in BCDVA (Best-corrected Distance Visual Acuity) - ETDRS Score | Right eye - Day 7±1 | 0.1 score on a scale | Standard Deviation 0.6 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in BCDVA (Best-corrected Distance Visual Acuity) - ETDRS Score | Right eye - Day 21±1 | 0.0 score on a scale | Standard Deviation 1.1 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in BCDVA (Best-corrected Distance Visual Acuity) - ETDRS Score | Left eye - Day 14±1 | -0.1 score on a scale | Standard Deviation 0.8 |
Comparison: T-test on changes from baseline in Visual acuity score - Left eye - Day 7±1p-value: 0.233895% CI: [-0.75, 0.19]Student t-test for unpaired data
Comparison: T-test on changes from baseline in Visual acuity score - Right eye - Day 7±1p-value: 0.308195% CI: [-0.58, 0.19]Student t-test for unpaired data
Comparison: T-test on changes from baseline in Visual acuity score - Left eye - Day 14±1p-value: 0.428795% CI: [-2.57, 5.74]Student t-test for unpaired data
Comparison: T-test on changes from baseline in Visual acuity score - Right eye - Day 14±1p-value: 0.576595% CI: [-3.14, 5.44]Student t-test for unpaired data
Comparison: T-test on changes from baseline in Visual acuity score - Left eye - Day 21±1p-value: 0.025995% CI: [-2.18, -0.15]Student t-test for unpaired data
Comparison: T-test on changes from baseline in Visual acuity score - Right eye - Day 21±1p-value: 0.149695% CI: [-2.23, 0.37]Student t-test for unpaired data
Secondary
Change From Baseline in Corneal Fluorescein Surface Staining (Oxford Score)
The corneal fluorescein staining was graded by using the Oxford scheme to assess cornea and conjunctiva epithelium damage. The Oxford grading scale divides corneal staining into six groups according to severity from 0 (absent) to 5 (severe). The examiner compared the overall appearance of the patient's corneal staining with a reference figure, simulating the pattern of staining encountered in dry eye disease. No attempt was made to count the dots or to assess the position or confluence of the dots. The examiner selected the appropriate grade that best represented the state of corneal staining. The grading system recommended by NEI divides the cornea into five zones (central, superior, temporal, nasal, and inferior) and for each zone, the severity of corneal fluorescein staining is graded on a scale from 0 to 3 based on reference figures. Therefore, the maximum score (worst outcome) was 15, the minimum (best outcome) was 0. Please note: both the eyes, right & left, were study-eyes.
Time frame: Visit 3 - Day 7±1, Visit 4 - Day 14±1 and Visit 5/Final visit/Follow up - Day 21±1
Population: The Full Analysis Set (FAS) population included all enrolled subjects, who received at least one dose of the IMD (Lubricin or Vismed®) during the treatment phase. This analysis set was used for the efficacy analysis. Data in the FAS are analyzed for each eye, left and right respectively. Each eye contributes to the analysis without having defined a study eye.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Corneal Fluorescein Surface Staining (Oxford Score) | Left eye - Day 14±1 | -1.4 score on a scale | Standard Deviation 1.1 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Corneal Fluorescein Surface Staining (Oxford Score) | Left eye - Day 7±1 | -0.8 score on a scale | Standard Deviation 0.6 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Corneal Fluorescein Surface Staining (Oxford Score) | Right eye - Day 7±1 | -0.7 score on a scale | Standard Deviation 0.8 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Corneal Fluorescein Surface Staining (Oxford Score) | Right eye - Day 14±1 | -1.5 score on a scale | Standard Deviation 0.8 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Corneal Fluorescein Surface Staining (Oxford Score) | Left eye - Day 21±1 | -1.8 score on a scale | Standard Deviation 1.1 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Corneal Fluorescein Surface Staining (Oxford Score) | Right eye - Day 21±1 | -1.8 score on a scale | Standard Deviation 0.8 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Corneal Fluorescein Surface Staining (Oxford Score) | Left eye - Day 21±1 | -0.8 score on a scale | Standard Deviation 0.9 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Corneal Fluorescein Surface Staining (Oxford Score) | Right eye - Day 14±1 | -0.9 score on a scale | Standard Deviation 0.9 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Corneal Fluorescein Surface Staining (Oxford Score) | Left eye - Day 7±1 | -0.6 score on a scale | Standard Deviation 0.5 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Corneal Fluorescein Surface Staining (Oxford Score) | Right eye - Day 21±1 | -1.1 score on a scale | Standard Deviation 0.9 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Corneal Fluorescein Surface Staining (Oxford Score) | Right eye - Day 7±1 | -0.9 score on a scale | Standard Deviation 0.8 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Corneal Fluorescein Surface Staining (Oxford Score) | Left eye - Day 14±1 | -0.7 score on a scale | Standard Deviation 0.6 |
Comparison: T-test on changes from baseline on corneal fluorescein surface staining - Left eye - Day 7 ±1p-value: 0.231795% CI: [-0.14, 0.57]Student t-test for unpaired data
Comparison: T-test on changes from baseline on corneal fluorescein surface staining - Right eye - Day 7 ±1p-value: 0.601795% CI: [-0.7, 0.41]Student t-test for unpaired data
Comparison: T-test on changes from baseline on corneal fluorescein surface staining - Left eye - Day 14 ±1p-value: 0.023295% CI: [0.11, 1.36]Student t-test for unpaired data
Comparison: T-test on changes from baseline on corneal fluorescein surface staining - Right eye - Day 14 ±1p-value: 0.039895% CI: [0.03, 1.17]Student t-test for unpaired data
Comparison: T-test on changes from baseline on corneal fluorescein surface staining - Left eye - Day 21 ±1p-value: 0.003895% CI: [0.36, 1.74]Student t-test for unpaired data
Comparison: T-test on changes from baseline on corneal fluorescein surface staining - right eyep-value: 0.013595% CI: [0.17, 1.33]Student t-test for unpaired data
Secondary
Change From Baseline in IOP (Intraocular Pressure)
The intraocular pressure (IOP) of the eye was determined by the balance between the amount of aqueous humor that the eye marked and the ease with which it leaved the eye. IOP was performed using Goldmann applanation tonometry after the instillation of a topical anaesthetic. The Goldmann applanation tonometer measured the force necessary to flatten a corneal area of 3.06 mm diameter. At this diameter, the resistance of the cornea to flattening was counterbalanced by the capillary attraction of the tear film meniscus for the tonometer head. The IOP (in mm Hg) equals the flattening force (in grams) multiplied by 10. IOP was measured in both eyes after completion of all other SLEs to avoid potential interference with the other evaluations. Both eyes were tested. Normal eye pressure was between 10 to 21 mm Hg. High intraocular pressure was greater than 21 mm Hg. Please note: ophthalmological evaluations were performed for both eyes. Hence both eyes - right and left - were study-eyes.
Time frame: Visit 3 - Day 7±1, Visit 4 - Day 14±1 and Visit 5/Final visit/Follow up - Day 21±1
Population: The Full Analysis Set (FAS) population included all enrolled subjects, who received at least one dose of the IMD (Lubricin or Vismed®) during the treatment phase. Data in the FAS are analyzed for each eye, left and right respectively. Each eye contributes to the analysis without having defined a study eye.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lubricin 150 μg/ml (FAS) | Change From Baseline in IOP (Intraocular Pressure) | Left eye - Day 7±1 | -0.5 mmHg | Standard Deviation 1.6 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in IOP (Intraocular Pressure) | Right eye - Day 7±1 | -0.3 mmHg | Standard Deviation 1.8 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in IOP (Intraocular Pressure) | Left eye - Day 14±1 | -0.1 mmHg | Standard Deviation 2.5 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in IOP (Intraocular Pressure) | RIght eye - Day 14±1 | 0.6 mmHg | Standard Deviation 2.1 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in IOP (Intraocular Pressure) | Left eye - Day 21±1 | -0.3 mmHg | Standard Deviation 1.7 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in IOP (Intraocular Pressure) | Right eye - Day 21±1 | -0.3 mmHg | Standard Deviation 2.5 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in IOP (Intraocular Pressure) | Left eye - Day 21±1 | 0.5 mmHg | Standard Deviation 2 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in IOP (Intraocular Pressure) | Left eye - Day 7±1 | 0.7 mmHg | Standard Deviation 1.9 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in IOP (Intraocular Pressure) | RIght eye - Day 14±1 | -0.2 mmHg | Standard Deviation 2 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in IOP (Intraocular Pressure) | Right eye - Day 7±1 | 0.2 mmHg | Standard Deviation 1.7 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in IOP (Intraocular Pressure) | Right eye - Day 21±1 | 0.2 mmHg | Standard Deviation 2.6 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in IOP (Intraocular Pressure) | Left eye - Day 14±1 | 0.2 mmHg | Standard Deviation 2.1 |
Comparison: T-test on changes from baseline in Intraocular pressure - Left eye - Day 7±1p-value: 0.059995% CI: [-0.05, 2.29]Student t-test for unpaired data
Comparison: T-test on changes from baseline in Intraocular pressure - Right eye - Day 7±1p-value: 0.396995% CI: [-0.68, 1.66]Student t-test for unpaired data
Comparison: T-test on changes from baseline in Intraocular pressure - Left eye - Day 14±1p-value: 0.722595% CI: [-1.29, 1.84]Student t-test for unpaired data
Comparison: T-test on changes from baseline in Intraocular pressure - Right eye - Day 14±1p-value: 0.26995% CI: [-2.14, 0.62]Student t-test for unpaired data
Comparison: T-test on changes from baseline in Intraocular pressure - Left eye - Day 21±1p-value: 0.234495% CI: [-0.53, 2.1]Student t-test for unpaired data
Comparison: T-test on changes from baseline in Intraocular pressure - Right eyep-value: 0.595395% CI: [-1.3, 2.24]Student t-test for unpaired data
Secondary
Change From Baseline in OPI (Ocular Protection Index)
OPI was used to quantify the interaction between tear film break-up time and blink intervals of a subject. It was based on the idea that, even when the TBUT was normal, if the blink interval was too slow it may cause breakage of tear film due to increased evaporation. The OPI was calculated by dividing TFBUT by inter blink interval (IBI). A visual count of the number of blinks per minute was performed while the subject read the ETDRS chart. ETDRS charts had five Sloan letters on each line; the lines were of equal difficulty, and there was a geometric progression in letter size from line to line. If the IBI and TBUT was same, dividing both give a value of 1.0. If TFBUT was more than IBI, dividing both, gave a value more than 1.0, so dryness would not occur. If TFBUT was less than IBI, dividing both gave a value less than 1.0. A subject was at risk of developing dry eye if the OPI was \< 1.0; so the higher the score the better the outcome. Both eyes - right and left - were study-eyes.
Time frame: Visit 3 - Day 7±1, Visit 4 - Day 14±1 and Visit 5/Final visit/Follow up - Day 21±1
Population: The Full Analysis Set (FAS) population included all enrolled subjects, who received at least one dose of the IMD (Lubricin or Vismed®) during the treatment phase. Data in the FAS are analyzed for each eye, left and right respectively. Each eye contributes to the analysis without having defined a study eye.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lubricin 150 μg/ml (FAS) | Change From Baseline in OPI (Ocular Protection Index) | Left eye - Day 7±1 | 0.1 score on a scale | Standard Deviation 1 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in OPI (Ocular Protection Index) | Right eye - Day 7±1 | 0.1 score on a scale | Standard Deviation 0.8 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in OPI (Ocular Protection Index) | Left eye - Day 14±1 | 0.2 score on a scale | Standard Deviation 0.9 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in OPI (Ocular Protection Index) | Right eye - Day 14±1 | 0.3 score on a scale | Standard Deviation 1.1 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in OPI (Ocular Protection Index) | Left eye - Day 21±1 | 0.2 score on a scale | Standard Deviation 0.8 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in OPI (Ocular Protection Index) | Right eye - Day 21±1 | 0.3 score on a scale | Standard Deviation 1.1 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in OPI (Ocular Protection Index) | Left eye - Day 21±1 | -0.2 score on a scale | Standard Deviation 0.8 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in OPI (Ocular Protection Index) | Left eye - Day 7±1 | 0.3 score on a scale | Standard Deviation 0.8 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in OPI (Ocular Protection Index) | Right eye - Day 14±1 | 0.0 score on a scale | Standard Deviation 0.9 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in OPI (Ocular Protection Index) | Right eye - Day 7±1 | 0.4 score on a scale | Standard Deviation 0.7 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in OPI (Ocular Protection Index) | Right eye - Day 21±1 | -0.1 score on a scale | Standard Deviation 0.9 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in OPI (Ocular Protection Index) | Left eye - Day 14±1 | 0.0 score on a scale | Standard Deviation 0.8 |
Comparison: T-test on changes from baseline in Ocular Protection Index - Left eye - Day 7±1p-value: 0.49895% CI: [-0.4, 0.81]Student t-test for unpaired data
Comparison: T-test on changes from baseline in Ocular Protection Index - Right eye - Day 7±1p-value: 0.198695% CI: [-0.18, 0.83]Student t-test for unpaired data
Comparison: T-test on changes from baseline in Ocular Protection Index - Left eye - Day 14±1p-value: 0.406795% CI: [-0.9, 0.37]Student t-test for unpaired data
Comparison: T-test on changes from baseline in Ocular Protection Index - Right eye - Day 14±1p-value: 0.525695% CI: [-0.81, 0.42]Student t-test for unpaired data
Comparison: T-test on changes from baseline in Ocular Protection Index - Left eye - Day 21±1p-value: 0.147195% CI: [-1.12, 0.17]Student t-test for unpaired data
Comparison: T-test on changes from baseline in Ocular Protection Index - Right eye - Day 21±1p-value: 0.245595% CI: [-0.96, 0.25]Student t-test for unpaired data
Secondary
Change From Baseline in SANDE (Symptom Assessment in Dry Eye) - Frequency of Symptoms
The SANDE (Symptom Assessment in Dry Eye) questionnaire was a short questionnaire to evaluate both dry eye frequency and severity by using a 100 mm VAS. For the assessment, the subjects marked on the 100 mm VAS line the point that they felt represented their perception of their current state. The VAS score was determined by measuring in millimetres from the left hand end of the line to the point that the subject marked. The SANDE scores was then evaluated for the 2 questions severity (0-100) and frequency (0-100), where 0 was the best condition and 100 marked the worst condition. Please note that ophthalmological evaluations were performed for both eyes. Hence both the eyes - right and left - were study-eyes.
Time frame: Visit 3 - Day 7±1, Visit 4 - Day 14±1 and Visit 5/Final visit/Follow up - Day 21±1
Population: The Full Analysis Set (FAS) population included all enrolled subjects, who received at least one dose of the IMD (Lubricin or Vismed®) during the treatment phase. This analysis set was used for the efficacy analysis. Data in the FAS are analyzed for each eye, left and right respectively. Each eye contributes to the analysis without having defined a study eye.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lubricin 150 μg/ml (FAS) | Change From Baseline in SANDE (Symptom Assessment in Dry Eye) - Frequency of Symptoms | Day 7±1 | -29.6 mm | Standard Deviation 31.8 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in SANDE (Symptom Assessment in Dry Eye) - Frequency of Symptoms | Day 14±1 | -39.6 mm | Standard Deviation 29.3 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in SANDE (Symptom Assessment in Dry Eye) - Frequency of Symptoms | Day 21±1 | -39.7 mm | Standard Deviation 30.9 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in SANDE (Symptom Assessment in Dry Eye) - Frequency of Symptoms | Day 14±1 | -21.4 mm | Standard Deviation 22.7 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in SANDE (Symptom Assessment in Dry Eye) - Frequency of Symptoms | Day 7±1 | -18.4 mm | Standard Deviation 17.8 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in SANDE (Symptom Assessment in Dry Eye) - Frequency of Symptoms | Day 21±1 | -16.2 mm | Standard Deviation 22.5 |
Comparison: T-test on changes from baseline in symptom assessment in dry eye - Frequency - Day 7±1p-value: 0.207595% CI: [-6.66, 29.14]Student t-test for unpaired data
Comparison: T-test on changes from baseline in symptom assessment in dry eye - Frequency - Day 14±1p-value: 0.043595% CI: [0.57, 35.76]Student t-test for unpaired data
Comparison: T-test on changes from baseline in symptom assessment in dry eye - Frequency - Day 21±1p-value: 0.013395% CI: [5.24, 41.93]Student t-test for unpaired data
Secondary
Change From Baseline in SANDE (Symptom Assessment in Dry Eye) - Severity of Symptoms
The SANDE (Symptom Assessment in Dry Eye) questionnaire was a short questionnaire to evaluate both dry eye severity and frequency by using a 100 mm VAS. For the assessment, the subjects marked on the 100 mm VAS line the point that they felt represented their perception of their current state. The VAS score was determined by measuring in millimetres from the left hand end of the line to the point that the subject marked. The SANDE scores were evaluated for the 2 questions severity (0-100) and frequency (0-100), where 0 was the best condition and 100 marked the worst condition. Please note that ophthalmological evaluations were performed for both eyes. Hence both the eyes - right and left - were study-eyes.
Time frame: Visit 3 - Day 7±1, Visit 4 - Day 14±1 and Visit 5/Final visit/Follow up - Day 21±1
Population: The Full Analysis Set (FAS) population included all enrolled subjects, who received at least one dose of the IMD (Lubricin or Vismed®) during the treatment phase. This analysis set was used for the efficacy analysis. Data in the FAS are analyzed for each eye, left and right respectively. Each eye contributes to the analysis without having defined a study eye.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lubricin 150 μg/ml (FAS) | Change From Baseline in SANDE (Symptom Assessment in Dry Eye) - Severity of Symptoms | Day 7±1 | -25.1 mm | Standard Deviation 31.2 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in SANDE (Symptom Assessment in Dry Eye) - Severity of Symptoms | Day 14±1 | -37.0 mm | Standard Deviation 26.5 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in SANDE (Symptom Assessment in Dry Eye) - Severity of Symptoms | Day 21±1 | -35.8 mm | Standard Deviation 29.1 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in SANDE (Symptom Assessment in Dry Eye) - Severity of Symptoms | Day 7±1 | -20.7 mm | Standard Deviation 2.03 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in SANDE (Symptom Assessment in Dry Eye) - Severity of Symptoms | Day 14±1 | -24.3 mm | Standard Deviation 19.2 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in SANDE (Symptom Assessment in Dry Eye) - Severity of Symptoms | Day 21±1 | -22.4 mm | Standard Deviation 19.3 |
Comparison: T-test on changes from baseline in symptom assessment in dry eye - Severity - Day 7±1p-value: 0.61395% CI: [-12.98, 21.69]Student t-test for unpaired data
Comparison: T-test on changes from baseline in symptom assessment in dry eye - Severity - Day 14±1p-value: 0.104795% CI: [-2.78, 28.18]Student t-test for unpaired data
Comparison: T-test on changes from baseline in symptom assessment in dry eye - Severity - Day 21±1p-value: 0.110895% CI: [-3.24, 30.04]Student t-test for unpaired data
Secondary
Change From Baseline in Schirmer Test I (Without Anaesthesia)
The Schirmer test type I (without anaesthesia) was performed to measure aqueous tear secretion prior to the instillation of any dilating or anaesthetic eye drops.The rounded bent end of a sterile strip was inserted into the lower conjunctival sac over the temporal one-third of the lower eyelid margin. After 5 minutes had elapsed, the Schirmers test strip was removed and the length of the tear absorption on the strip was measured (millimeters/5 minutes). Changes from baseline in values of Schirmer's test type I were summarised by eye and evaluation visit, and stratified by severity level. The longer the wetted length, the healthier the status of the eye. Please note that Ophthalmological evaluations were performed for both eyes. Hence both the eyes - right and left - were study-eyes.
Time frame: Visit 3 - Day 7±1, Visit 4 - Day 14±1 and Visit 5/Final visit/Follow up - Day 21±1
Population: The Full Analysis Set (FAS) population included all enrolled subjects, who received at least one dose of the IMD (Lubricin or Vismed®) during the treatment phase. Data in the FAS are analyzed for each eye, left and right respectively. Each eye contributes to the analysis without having defined a study eye.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Schirmer Test I (Without Anaesthesia) | Right eye - Day 14±1 | 1.8 score on a scale | Standard Deviation 3.9 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Schirmer Test I (Without Anaesthesia) | Right eye - Day 7±1 | 1.0 score on a scale | Standard Deviation 3 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Schirmer Test I (Without Anaesthesia) | Left eye - Day 21±1 | 1.4 score on a scale | Standard Deviation 2.2 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Schirmer Test I (Without Anaesthesia) | Left eye - Day 7±1 | 0.8 score on a scale | Standard Deviation 1.3 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Schirmer Test I (Without Anaesthesia) | Right eye - Day 21±1 | 1.6 score on a scale | Standard Deviation 4.1 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Schirmer Test I (Without Anaesthesia) | Left eye - Day 14±1 | 1.4 score on a scale | Standard Deviation 1.4 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Schirmer Test I (Without Anaesthesia) | Right eye - Day 21±1 | 0.4 score on a scale | Standard Deviation 2.7 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Schirmer Test I (Without Anaesthesia) | Left eye - Day 7±1 | 1.4 score on a scale | Standard Deviation 2.3 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Schirmer Test I (Without Anaesthesia) | Right eye - Day 7±1 | 0.8 score on a scale | Standard Deviation 2.2 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Schirmer Test I (Without Anaesthesia) | Right eye - Day 14±1 | 0.5 score on a scale | Standard Deviation 2.5 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Schirmer Test I (Without Anaesthesia) | Left eye - Day 21±1 | 0.3 score on a scale | Standard Deviation 3.2 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Schirmer Test I (Without Anaesthesia) | Left eye - Day 14±1 | 1.4 score on a scale | Standard Deviation 2.1 |
Comparison: T-test on changes from baseline on Schirmer's test type I strip wetting distance - Left eye - Day 7±1p-value: 0.344295% CI: [-0.66, 1.83]Student t-test for unpaired data
Comparison: T-test on changes from baseline on Schirmer's test type I strip wetting distance - Right eye - Day 7±1p-value: 0.77295% CI: [-1.99, 1.49]Student t-test for unpaired data
Comparison: T-test on changes from baseline on Schirmer's test type I strip wetting distance - Left eye - Day 14±1p-value: 0.972595% CI: [-1.49, 1.44]Student t-test for unpaired data
Comparison: T-test on changes from baseline on Schirmer's test type I strip wetting distance - Right eye - Day 14±1p-value: 0.211195% CI: [-3.54, 0.81]Student t-test for unpaired data
Comparison: T-test on changes from baseline on Schirmer's test type I strip wetting distance - Left eye - Day 21±1p-value: 0.262990% CI: [-3.06, 0.86]Student t-test for unpaired data
Comparison: T-test on changes from baseline on Schirmer's test type I strip wetting distance - Right eye - 21±1p-value: 0.286295% CI: [-3.6, 1.1]Student t-test for unpaired data
Secondary
Change From Baseline in Slit Lamp Examination (SLE)
The Slit Lamp Examination was used to examine the structures of the eye (eyelids, lashes, conjunctiva, cornea, lens, iris and anterior chamber) according to different scales: Eyelid - Meibomian glands (from 0-none to 3-severe), Eyelid - Erythema (from 0-none to 4-very severe), Eyelid - Oedema (from 0-none to 4-very severe), Lashes (0-normal 1-abnormal), Conjunctiva - Erythema (from 0-none to 3-severe), Conjunctiva - Oedema (from 0-none to 4-very severe), Lens (from 0-no opacification to 3-severe lens opacification), Iris (0-normal 1-abnormal), Anterior chamber inflammation (from 0-none to 3-severe), Cornea transparency (from 0-completely transparent to 4-complete cornea opacity), Cornea neovascularization (0-absence of neovascularization to 4-neovascularization between 270° and 360°). The higher the score the worse the outcome. There was not a total score. Please note: ophthalmological evaluations were performed for both eyes. Hence both eyes - right and left - were study-eyes.
Time frame: Visit 3 - Day 7±1, Visit 4 - Day 14±1 and Visit 5/Final visit/Follow up - Day 21±1
Population: The Full Analysis Set (FAS) population included all enrolled subjects, who received at least one dose of the IMD (Lubricin or Vismed®) during the treatment phase. Data in the FAS are analyzed for each eye, left and right respectively. Each eye contributes to the analysis without having defined a study eye.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Conjunctiva - Erythema (Left eye) - Day 14±1 | -0.9 score on a scale | Standard Deviation 0.9 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Conjunctiva - Oedema (Left eye) -Day 7±1 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Anterior chamber inflammation (Left eye) - Day 7±1 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Conjunctiva - Oedema (Right eye) -Day 7±1 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Eyelid - Oedema (Right eye) - Day 14±1 | -0.1 score on a scale | Standard Deviation 0.3 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Lens (Right eye) - Day 7±1 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Anterior chamber inflammation (Right eye) - Day 7±1 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Lens (Left eye) - Day 7±1 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Conjunctiva - Erythema (Right eye) - Day 14±1 | -0.7 score on a scale | Standard Deviation 0.9 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Iris (Left eye) - Day 7±1 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Eyelid - Erythema (Right eye) - Day14±1 | -0.5 score on a scale | Standard Deviation 0.5 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Cornea transparency (Right eye) - Day 7±1 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Lens (Right eye) - Day 14±1 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Conjunctiva - Oedema (Left eye) -Day 14±1 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Iris (Left eye) - Day 14±1 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Cornea neovascularization (Left eye) - Day 7±1 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Anterior chamber inflammation (Left eye) - Day 14±1 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Conjunctiva - Oedema (Right eye) -Day 14±1 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Cornea transparency (Right eye) - Day 14±1 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Eyelid - Meibomian glands (Left eye) - Day14±1 | -0.1 score on a scale | Standard Deviation 0.3 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Cornea neovascularization (Left eye) - Day 14±1 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Iris (Right eye) - Day 14±1 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Cornea neovascularization (Right eye) - Day 14±1 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Eyelid - Meibomian glands (Right eye) - Day14±1 | -0.2 score on a scale | Standard Deviation 0.4 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Lashes (Left eye) - Day 14±1 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Eyelid - Meibomian glands (Right eye) - Day 21±1 | -0.2 score on a scale | Standard Deviation 0.4 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Eyelid - Erythema (Left eye) - Day14±1 | -0.6 score on a scale | Standard Deviation 0.5 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Eyelid - Erythema (Left eye) - Day 21±1 | -0.8 score on a scale | Standard Deviation 0.7 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Cornea neovascularization (Right eye) - Day 7±1 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Eyelid - Erythema (Right eye) - Day 21±1 | -0.6 score on a scale | Standard Deviation 0.6 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Eyelid - Meibomian glands (Left eye) - Day 7±1 | -0.1 score on a scale | Standard Deviation 0.3 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Eyelid - Oedema (Left eye) - Day 21±1 | -0.1 score on a scale | Standard Deviation 0.3 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Anterior chamber inflammation (Right eye) - Day 14±1 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Eyelid - Meibomian glands (Right eye) - Day 7±1 | -0.2 score on a scale | Standard Deviation 0.4 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Lashes (Left eye) - Day 21±1 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Lashes (Right eye) - Day 14±1 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Lashes (Right eye) - Day 21±1 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Eyelid - Erythema (Left eye) - Day 7±1 | -0.4 score on a scale | Standard Deviation 0.5 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Conjunctiva - Erythema (Left eye) - Day 21±1 | -0.9 score on a scale | Standard Deviation 0.9 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Cornea transparency (Left eye) - Day 14±1 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Conjunctiva - Erythema (Right eye) - Day 21±1 | -0.8 score on a scale | Standard Deviation 0.7 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Eyelid - Erythema (Right eye) - Day 7±1 | -0.3 score on a scale | Standard Deviation 0.5 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Conjunctiva - Oedema (Left eye) -Day 21±1 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Eyelid - Meibomian glands (Left eye) - Day 21±1 | -0.2 score on a scale | Standard Deviation 0.4 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Conjunctiva - Oedema (Right eye) -Day 21±1 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Eyelid - Oedema (Left eye) - Day 7±1 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Lens (Right eye) - Day 21±1 | -0.1 score on a scale | Standard Deviation 0.3 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Eyelid - Oedema ( Right eye) - Day 21±1 | -0.1 score on a scale | Standard Deviation 0.3 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Iris (Left eye) - Day 21±1 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Cornea transparency (Left eye) - Day 7±1 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Iris (Right eye) - Day 21±1 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Eyelid - Oedema (Right eye) - Day 7±1 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Anterior chamber inflammation (Left eye) - Day 21±1 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Lens (Left eye) - Day 21±1 | -0.1 score on a scale | Standard Deviation 0.3 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Anterior chamber inflammation (Right eye) - Day 21±1 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Lashes (Left eye) - Day 7±1 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Cornea transparency (Left eye) - Day 21±1 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Eyelid - Oedema (Left eye) - Day 14±1 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Cornea transparency (Right eye) - Day 21±1 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Lashes (Right eye) - Day 7±1 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Cornea neovascularization (Left eye) - Day 21±1 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Cornea neovascularization (Right eye) - Day 21±1 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Conjunctiva - Erythema (Left eye) - Day 7±1 | -0.4 score on a scale | Standard Deviation 0.7 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Iris (Right eye) - Day 7±1 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Conjunctiva - Erythema (Right eye) - Day 7±1 | -0.4 score on a scale | Standard Deviation 0.6 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Lens (Left eye) - Day 14±1 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Iris (Left eye) - Day 21±1 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Cornea neovascularization (Right eye) - Day 7±1 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Eyelid - Erythema (Left eye) - Day14±1 | -0.2 score on a scale | Standard Deviation 0.4 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Eyelid - Erythema (Right eye) - Day14±1 | -0.1 score on a scale | Standard Deviation 0.3 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Eyelid - Oedema (Right eye) - Day 14±1 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Lashes (Left eye) - Day 14±1 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Lashes (Right eye) - Day 14±1 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Conjunctiva - Erythema (Left eye) - Day 14±1 | -0.2 score on a scale | Standard Deviation 0.4 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Conjunctiva - Erythema (Right eye) - Day 14±1 | -0.3 score on a scale | Standard Deviation 0.4 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Iris (Right eye) - Day 14±1 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Anterior chamber inflammation (Left eye) - Day 14±1 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Anterior chamber inflammation (Right eye) - Day 14±1 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Lens (Left eye) - Day 21±1 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Iris (Right eye) - Day 7±1 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Anterior chamber inflammation (Left eye) - Day 7±1 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Anterior chamber inflammation (Right eye) - Day 7±1 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Cornea transparency (Left eye) - Day 7±1 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Cornea transparency (Right eye) - Day 7±1 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Cornea neovascularization (Left eye) - Day 7±1 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Eyelid - Meibomian glands (Left eye) - Day14±1 | -0.2 score on a scale | Standard Deviation 0.4 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Eyelid - Meibomian glands (Right eye) - Day14±1 | -0.1 score on a scale | Standard Deviation 0.4 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Eyelid - Oedema (Left eye) - Day 14±1 | -0.1 score on a scale | Standard Deviation 0.2 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Eyelid - Meibomian glands (Left eye) - Day 7±1 | -0.1 score on a scale | Standard Deviation 0.3 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Eyelid - Meibomian glands (Right eye) - Day 7±1 | -0.1 score on a scale | Standard Deviation 0.2 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Eyelid - Erythema (Left eye) - Day 7±1 | -0.2 score on a scale | Standard Deviation 0.4 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Eyelid - Erythema (Right eye) - Day 7±1 | -0.1 score on a scale | Standard Deviation 0.2 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Eyelid - Oedema (Left eye) - Day 7±1 | -0.1 score on a scale | Standard Deviation 0.2 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Eyelid - Oedema (Right eye) - Day 7±1 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Lashes (Left eye) - Day 7±1 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Lashes (Right eye) - Day 7±1 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Conjunctiva - Erythema (Left eye) - Day 7±1 | -0.2 score on a scale | Standard Deviation 0.4 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Conjunctiva - Erythema (Right eye) - Day 7±1 | -0.3 score on a scale | Standard Deviation 0.4 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Conjunctiva - Oedema (Left eye) -Day 7±1 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Conjunctiva - Oedema (Right eye) -Day 7±1 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Lens (Right eye) - Day 7±1 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Lens (Left eye) - Day 7±1 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Iris (Left eye) - Day 7±1 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Lens (Left eye) - Day 14±1 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Lens (Right eye) - Day 14±1 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Iris (Left eye) - Day 14±1 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Cornea transparency (Left eye) - Day 14±1 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Cornea transparency (Right eye) - Day 14±1 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Cornea neovascularization (Left eye) - Day 14±1 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Cornea neovascularization (Right eye) - Day 14±1 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Eyelid - Meibomian glands (Left eye) - Day 21±1 | -0.1 score on a scale | Standard Deviation 0.4 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Eyelid - Meibomian glands (Right eye) - Day 21±1 | 0.0 score on a scale | Standard Deviation 0.3 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Eyelid - Erythema (Left eye) - Day 21±1 | -0.2 score on a scale | Standard Deviation 0.6 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Eyelid - Erythema (Right eye) - Day 21±1 | -0.1 score on a scale | Standard Deviation 0.7 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Eyelid - Oedema (Left eye) - Day 21±1 | -0.1 score on a scale | Standard Deviation 0.2 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Eyelid - Oedema ( Right eye) - Day 21±1 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Lashes (Left eye) - Day 21±1 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Lashes (Right eye) - Day 21±1 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Conjunctiva - Erythema (Left eye) - Day 21±1 | -0.1 score on a scale | Standard Deviation 0.6 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Conjunctiva - Erythema (Right eye) - Day 21±1 | -0.2 score on a scale | Standard Deviation 0.7 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Conjunctiva - Oedema (Left eye) -Day 21±1 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Conjunctiva - Oedema (Right eye) -Day 21±1 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Lens (Right eye) - Day 21±1 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Iris (Right eye) - Day 21±1 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Anterior chamber inflammation (Left eye) - Day 21±1 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Anterior chamber inflammation (Right eye) - Day 21±1 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Cornea transparency (Left eye) - Day 21±1 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Cornea transparency (Right eye) - Day 21±1 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Cornea neovascularization (Left eye) - Day 21±1 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Cornea neovascularization (Right eye) - Day 21±1 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Conjunctiva - Oedema (Left eye) -Day 14±1 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in Slit Lamp Examination (SLE) | Conjunctiva - Oedema (Right eye) -Day 14±1 | 0.0 score on a scale | Standard Deviation 0 |
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea transparency - Left - Day 7±1p-value: 1Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Meibomian Glands - Right - Day 7±1p-value: 0.2342Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Meibomian Glands - Left - Day 7±1p-value: 0.8874Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Erythema - Right - Day 7±1p-value: 0.0504Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Erythema - Left - Day 7±1p-value: 0.0814Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Oedema - Right - Day 7±1p-value: 1Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Oedema - Left - Day 7±1p-value: 0.3855Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lashes - Right - Day 7±1p-value: 1Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lashes - Left - Day 7±1p-value: 1Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Erythema - Right - Day 7±1p-value: 0.4754Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Erythema - Left - Day 7±1p-value: 0.2914Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Oedema - Right - Day 7±1p-value: 1Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Oedema - Left - Day 7±1p-value: 1Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lens - Right - Day 7±1p-value: 1Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lens - Left - Day 7±1p-value: 1Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Iris - Right - Day 7±1p-value: 1Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Iris - Left - Day 7±1p-value: 1Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Anterior chamber inflammation - Right - Day 7±1p-value: 1Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Anterior chamber inflammation - Left - Day 7±1p-value: 1Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea transparency - Right - Day 7±1p-value: 1Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea neovascularization - Right - Day 7±1p-value: 1Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea neovascularization - Left - Day 7±1p-value: 1Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Meibomian Glands - Right - Day 14±1p-value: 0.2429Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Meibomian Glands - Left - Day 14±1p-value: 0.5707Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Erythema - Right - Day 14±1p-value: 0.0092Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Erythema - Left - Day 14±1p-value: 0.0039Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Oedema - Right - Day 14±1p-value: 0.2882Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Oedema - Left - Day 14±1p-value: 0.4017Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lashes - Right - Day 14±1p-value: 1Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lashes - Left - Day 14±1p-value: 1Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Erythema - Right - Day 14±1p-value: 0.0731Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Erythema - Left - Day 14±1p-value: 0.002Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Oedema - Right - Day 14±1p-value: 1Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Oedema - Left - Day 14±1p-value: 1Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lens - Right - Day 14±1p-value: 1Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lens - Left - Day 14±1p-value: 1Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Iris - Right - Day 14±1p-value: 1Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Iris - Left - Day 14±1p-value: 1Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Anterior chamber inflammation - Right - Day 14±1p-value: 1Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Anterior chamber inflammation - Left - Day 14±1p-value: 1Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea transparency - Right - Day 14±1p-value: 1Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea transparency - Left - Day 14±1p-value: 1Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea neovascularization - Right - Day 14±1p-value: 1Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea neovascularization - Left - Day 14±1p-value: 1Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Meibomian Glands - Right - Day 21±1p-value: 0.1376Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Meibomian Glands - Left - Day 21±1p-value: 0.3252Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Erythema - Right - Day 21±1p-value: 0.0111Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Erythema - Right - Day 21±1p-value: 0.0049Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Oedema - Right - Day 21±1p-value: 0.1178Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Oedema - Left - Day 21±1p-value: 0.9042Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lashes - Right - Day 21±1p-value: 1Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lashes - Left - Day 21±1p-value: 1Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Erythema - Right - Day 21±1p-value: 0.0253Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Erythema - Left - Day 21±1p-value: 0.0016Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Oedema - Right - Day 21±1p-value: 1Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Oedema - Left - Day 21±1p-value: 1Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lens - Right - Day 21±1p-value: 0.3165Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lens - Left - Day 21±1p-value: 0.3165Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Iris - Right - Day 21±1p-value: 1Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Iris - Left - Day 21±1p-value: 1Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Anterior chamber inflammation - Right - Day 21±1p-value: 1Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Anterior chamber inflammation - Left - Day 21±1p-value: 1Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea transparency - Right - Day 21±1p-value: 1Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea transparency - Left - Day 21±1p-value: 1Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea neovascularization - Right - Day 21±1p-value: 1Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea neovascularization - Left - Day 21±1p-value: 1Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in TFBUT (Tear Film Break Up Time)
TFBUT was measured by determining the time to tear break-up. The TFBUT test was performed after instillation of 5 µl of 2% preservative-free sodium fluorescein solution into the inferior conjunctival cul-de-sac of each eye. With the aid of a slit lamp at 10X magnification using cobalt blue illumination, the examiner monitored the integrity of the tear film, noting the time it took to form lacunae (clear spaces in the tear film) from the time that the eye was opened after the last blink. This measurement was performed within 10 seconds maximum. The TFBUT was measured twice during the first minute after the instillation of the fluorescein. If the 2 readings differed by more than 2 seconds, a third reading was taken. The TFBUT value was the average of the 2 or 3 measurements. Generally, a TFBUT value of 10-35 seconds was considered normal. A value of less than 10 seconds was usually suspicious and may indicate tear film instability. Both the eyes - right and left - were study-eyes.
Time frame: Visit 3 - Day 7±1, Visit 4 - Day 14±1 and Visit 5/Final visit/Follow up - Day 21±1
Population: The Full Analysis Set (FAS) population included all enrolled subjects, who received at least one dose of the IMD (Lubricin or Vismed®) during the treatment phase. Data in the FAS are analyzed for each eye, left and right respectively. Each eye contributes to the analysis without having defined a study eye.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lubricin 150 μg/ml (FAS) | Change From Baseline in TFBUT (Tear Film Break Up Time) | Left eye - Day 7±1 | 1.8 sec | Standard Deviation 2.4 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in TFBUT (Tear Film Break Up Time) | Right eye - Day 14±1 | 1.9 sec | Standard Deviation 2.4 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in TFBUT (Tear Film Break Up Time) | Left eye - Day 21±1 | 2.6 sec | Standard Deviation 2.8 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in TFBUT (Tear Film Break Up Time) | Right eye - Day 7±1 | 1.2 sec | Standard Deviation 2.3 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in TFBUT (Tear Film Break Up Time) | Right eye - Day 21±1 | 2.1 sec | Standard Deviation 2.9 |
| Lubricin 150 μg/ml (FAS) | Change From Baseline in TFBUT (Tear Film Break Up Time) | Left eye - Day 14±1 | 2.7 sec | Standard Deviation 2.4 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in TFBUT (Tear Film Break Up Time) | Right eye - Day 21±1 | 0.2 sec | Standard Deviation 2.4 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in TFBUT (Tear Film Break Up Time) | Left eye - Day 7±1 | 1.2 sec | Standard Deviation 1.9 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in TFBUT (Tear Film Break Up Time) | Left eye - Day 14±1 | 0.7 sec | Standard Deviation 2.1 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in TFBUT (Tear Film Break Up Time) | Right eye - Day 14±1 | 0.6 sec | Standard Deviation 2.3 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in TFBUT (Tear Film Break Up Time) | Left eye - Day 21±1 | 0.1 sec | Standard Deviation 2 |
| Sodium Hyaluronate 0.18% (FAS) | Change From Baseline in TFBUT (Tear Film Break Up Time) | Right eye - Day 7±1 | 1.5 sec | Standard Deviation 1.8 |
Comparison: T test p-value - Left eye - Day 7±1p-value: 0.423395% CI: [-1.98, 0.85]Student t-test for unpaired data
Comparison: T test p-value - Right eye - Day 7±1p-value: 0.633595% CI: [-1.04, 1.69]Student t-test for unpaired data
Comparison: T test p-value - Left eye - Day 14±1p-value: 0.010395% CI: [-3.56, -0.51]Student t-test for unpaired data
Comparison: T test p-value - Right eye - Day 14±1p-value: 0.100695% CI: [-2.95, 0.27]Student t-test for unpaired data
Comparison: T test p-value - Left eye - Day 21±1p-value: 0.004195% CI: [-4.15, -0.85]Student t-test for unpaired data
Comparison: T test p-value - Right eye - Day 21±1p-value: 0.042995% CI: [-3.67, -0.06]Student t-test for unpaired data
Secondary
Number of Instillations of IMD During the Second Week of the Clinical Investigation
The number of daily instillations of test and comparator IMD from from Visit 3 - Day 7±1 to Visit 4 - Day 14±1
Time frame: from Visit 3 - Day 7±1 to Visit 4 - Day 14±1
Population: The Full Analysis Set (FAS) population included all enrolled subjects, who received at least one dose of the IMD (Lubricin or Vismed®) during the treatment phase.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lubricin 150 μg/ml (FAS) | Number of Instillations of IMD During the Second Week of the Clinical Investigation | Day 7 | 4.7 number of daily administrations | Standard Error 1.1 |
| Lubricin 150 μg/ml (FAS) | Number of Instillations of IMD During the Second Week of the Clinical Investigation | Day 8 | 3.7 number of daily administrations | Standard Error 1.5 |
| Lubricin 150 μg/ml (FAS) | Number of Instillations of IMD During the Second Week of the Clinical Investigation | Day 9 | 3.9 number of daily administrations | Standard Error 1.3 |
| Lubricin 150 μg/ml (FAS) | Number of Instillations of IMD During the Second Week of the Clinical Investigation | Day 10 | 3.7 number of daily administrations | Standard Error 1.1 |
| Lubricin 150 μg/ml (FAS) | Number of Instillations of IMD During the Second Week of the Clinical Investigation | Day 11 | 3.7 number of daily administrations | Standard Error 1 |
| Lubricin 150 μg/ml (FAS) | Number of Instillations of IMD During the Second Week of the Clinical Investigation | Day 12 | 3.4 number of daily administrations | Standard Error 1.1 |
| Lubricin 150 μg/ml (FAS) | Number of Instillations of IMD During the Second Week of the Clinical Investigation | Day 13 | 3.7 number of daily administrations | Standard Error 1.2 |
| Lubricin 150 μg/ml (FAS) | Number of Instillations of IMD During the Second Week of the Clinical Investigation | Day 14 | 3.7 number of daily administrations | Standard Error 1.3 |
| Sodium Hyaluronate 0.18% (FAS) | Number of Instillations of IMD During the Second Week of the Clinical Investigation | Day 14 | 4.2 number of daily administrations | Standard Error 1.1 |
| Sodium Hyaluronate 0.18% (FAS) | Number of Instillations of IMD During the Second Week of the Clinical Investigation | Day 7 | 5.5 number of daily administrations | Standard Error 1 |
| Sodium Hyaluronate 0.18% (FAS) | Number of Instillations of IMD During the Second Week of the Clinical Investigation | Day 11 | 4.4 number of daily administrations | Standard Error 1.2 |
| Sodium Hyaluronate 0.18% (FAS) | Number of Instillations of IMD During the Second Week of the Clinical Investigation | Day 8 | 5.1 number of daily administrations | Standard Error 1 |
| Sodium Hyaluronate 0.18% (FAS) | Number of Instillations of IMD During the Second Week of the Clinical Investigation | Day 13 | 4.5 number of daily administrations | Standard Error 0.9 |
| Sodium Hyaluronate 0.18% (FAS) | Number of Instillations of IMD During the Second Week of the Clinical Investigation | Day 9 | 4.2 number of daily administrations | Standard Error 1.1 |
| Sodium Hyaluronate 0.18% (FAS) | Number of Instillations of IMD During the Second Week of the Clinical Investigation | Day 12 | 4.3 number of daily administrations | Standard Error 1.1 |
| Sodium Hyaluronate 0.18% (FAS) | Number of Instillations of IMD During the Second Week of the Clinical Investigation | Day 10 | 4.3 number of daily administrations | Standard Error 1 |
Comparison: T-test on number of daily administrations of IMD during the second week of the clinical investigation - Day 7p-value: 0.219395% CI: [-0.54, 2.11]Student t-test for unpaired data
Comparison: T-test on number of daily administrations of IMD during the second week of the clinical investigation - Day 8p-value: 0.002495% CI: [0.51, 2.18]Student t-test for unpaired data
Comparison: T-test on number of daily administrations of IMD during the second week of the clinical investigation - Day 9p-value: 0.42595% CI: [-0.49, 1.14]Student t-test for unpaired data
Comparison: T-test on number of daily administrations of IMD during the second week of the clinical investigation - Day 10p-value: 0.127595% CI: [-0.17, 1.29]Student t-test for unpaired data
Comparison: T-test on number of daily administrations of IMD during the second week of the clinical investigation - Day 11p-value: 0.084495% CI: [-0.09, 1.42]Student t-test for unpaired data
Comparison: T-test on number of daily administrations of IMD during the second week of the clinical investigation - Day 12p-value: 0.023895% CI: [0.12, 1.6]Student t-test for unpaired data
Comparison: T-test on number of daily administrations of IMD during the second week of the clinical investigation - Day 13p-value: 0.036995% CI: [0.05, 1.61]Student t-test for unpaired data
Comparison: T-test on number of daily administrations of IMD during the second week of the clinical investigation - Day 14p-value: 0.349695% CI: [-0.61, 1.64]Student t-test for unpaired data