Dry Eye Syndrome, Tear Film Insufficiency
Conditions
Keywords
Dry Eye
Brief summary
The objective of the clinical investigation was to evaluate tolerability, safety and efficacy of the tested medical device, eye drop containing Lubricin 150 µg/mL, as compared with a standard sodium hyaluronate 0.13% eye drop solution in subjects with moderate dry eye disease. Primary objective: • Symptom Assessment in Dry Eye (SANDE) Secondary objectives: * Treatment-emergent adverse events (TEAEs); * Visual analogue scale (VAS) for ocular tolerability (foreign body sensation, burning/stinging, itching, pain, stick feeling, blurred vision and photophobia); * Tear film osmolarity; * Assessment of best corrected distance visual acuity (BCDVA) * Slit lamp examination (SLE) to assess the Eyelid - Meibomian glands, Eyelid Erythema, Eyelid Oedema, Lashes, Conjunctiva Erythema, Lens, Iris, Anterior Chamber, Corneal transparency, Corneal neovascularization; * Tear film break-up time (TFBUT); * Corneal fluorescein surface staining (scored using the Oxford scale); * Schirmer-I test (without anaesthesia) values; * Intraocular Pressure (IOP) All parameters will be evaluated at screening visit, baseline (day 1), visit 3 (day 14±2) and visit 4 (day 28±4) and at follow-up (final visit) at least 7 days but not more than 9 days after the last treatment. The results for both the SANDE questionnaire and adverse events are reported at the patient level, without distinguishing between Study Eye and Non-Study Eye. This approach reflects the overall condition and experiences of the patient rather than attributing outcomes to individual eyes. The Study Eye was identified as the eye with the worst overall tolerability score at Visit 2 (Day 1).
Detailed description
This study is a multicenter, randomized, double-masked, controlled, non-inferiority study to evaluate tolerability, safety and efficacy of Lubricin eye drops versus sodium hyaluronate eye drops (Ocuyal®) administered four times a day for 4 weeks and 1 week follow-up in subjects with moderate dry eye.
Interventions
DEVICELubricin
Lubricin 150 µg/ml eye drops
DEVICESodium Hyaluronate
Sodium hyaluronate 0.13% 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.
Intervention model description
This was a 4-week randomised (1:1), controlled, double-masked, non-inferiority clinical investigation in subjects with moderate dry eye disease. Subjects with moderate dry eye will be evaluated at screening (from day -14 to day -8), baseline (day 1), week 2 (day 14±2 days), week 4 (day 28±4 days, or early exit) and at week 5 (at least 7 days but not more than 9 days after V4). Treatment duration 28 days (4weeks) ± 4 days (maximum total study duration 32 days). During the Run-in period of 7 days only a saline solution 0.9%, Nebul®, was allowed to the subject in both eyes four times a day (QID) every 4 h±1 h. No ocular topical treatments were allowed, including artificial tears/lubricants. During the follow-up period (7-9 days) only Sodium hyaluronate (Na-HY) 0.13% eye drops monodose supplied by the Investigator will be allowed, to all subjects participating to the study, in both eyes as needed.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
To be checked at the screening visit (V1) from day -14 to day -8 days before run-in period and confirmed at baseline visit (V2): 1. Subjects 18 years of age or older. 2. Subjects with moderate dry eye characterized by tear film osmolarity \> 312 mOsm 3. Subjects with both VAS for frequency and severity of symptoms, SANDE items, at screening & baseline \> 25 mm (SANDE overall score \> 25 mm). 4. Subjects 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) 5. Subjects diagnosed with dry eye from at least 6 months (current use or recommended use of artificial tears/lubricants for the treatment of Dry Eye) 6. Best corrected distance visual acuity (BCDVA) score of ≥ 0.1 decimal units in both eyes at the time of study enrolment. 7. The Informed Consent form approved by the Ethics Committees should be signed by the subject before any study procedures.
Exclusion criteria
1. Evidence of an active ocular infection in either eye 2. History or presence of ocular surface disorders not related to dry eye in either eye 3. History or evidence of eyelid abnormality in either eye 4. 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 5. 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 6. 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 vasculitis, collagen vascular diseases, poorly controlled diabetes, autoimmune disease, systemic infection.) 7. Known hypersensitivity to one of the components of the test device or the comparator 8. Participation in another clinical study at the same time as the present study or within 90 days of baseline visit 9. History of drug, medication or alcohol abuse or addiction. 10. 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 IUD during the entire course of and 30 days after the study treatment periods.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline (V2) in Frequency and Severity of Dry Eye Symptoms (SANDE) Questionnaire Scores at Day 28±4 (End of Treatment) | Visit 3 - Day 14±2, Visit 4 - Day 28±4, Visit 5 - Final visit/Follow up - Day 31- 41 | The SANDE (Symptom Assessment in Dry Eye) questionnaire was used to evaluate both dry eye frequency and severity using a 100 mm VAS line, representing ocular dryness and/or irritation at subject's level, according to their own perception, irrespective of the eye being or not the study eye, as per study Protocol. SANDE scores ranged from 0 (best condition) to 100 (worst condition) for both severity and frequency. The VAS score was determined - in millimeters - by measuring from the left-hand end to the marked point on the VAS line. SANDE OVERALL VAS score was calculated considering the mean and the SD of the Change from Baseline values at Day 14±2, Day 28±4 and Day 31-41, both for frequency and severity, and then calculated as square-root of the product of the two item score. Results are reported at the patient level, rather than focusing on a single eye, as the SANDE score assesses overall dry eye symptoms rather than eye-specific effects, as per study protocol. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Visit 3 - Day 14±2, Visit 4 - Day 28±4, Visit 5 - Final visit/Follow up - Day 31- 41 | 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 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 extreme limits of the parameter. |
| Change From Baseline in Tear Film Osmolarity | Visit 3 - Day 14±2, Visit 4 - Day 28±4, Visit 5 - Final visit/Follow up - Day 31- 41 | Tear film osmolarity as a marker of tear film solute content was performed with a TearLab Osmolarity System. The concentration of the tears was assessed in both eyes before the instillation of any dilating or anaesthetic drops. The tear fluid was collected onto the bottom tip of the test card by passive capillary action. After a successful tear collection, the Pen was docked into the Reader, which showed the quantitative tear film osmolarity result in mOsm/L on the liquid crystal display. Normal Patients: 275-316 mOsms/L (mean 302 mOsms/L), Dry Eye Disease Patients: \> 316 mOsms/L. The higher the score the worst the outcome. |
| Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) - ETDRS Score | Visit 3 - Day 14±2, Visit 4 - Day 28±4, Visit 5 - Final visit/Follow up - Day 31- 41 | Best corrected visual acuity (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 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 meters, the subject was tested at 1 meter. If 20 or more letters were read at 4 meters, the VAS for that eye was recorded as the number of letters correct at 4 meters plus 30. Otherwise, the VAS was the number of letters read correctly at 1 meter plus the number read at 4 meters. The higher the score the better the outcome. |
| Change From Baseline in Permanence of Lubricin on the Ocular Surface - Tear Film Break-up Time (TFBUT) | Visit 3 - Day 14±2, Visit 4 - Day 28±4, Visit 5 - Final visit/Follow up - Day 31- 41 | 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. The higher the value, the better the outcome. |
| Treatment-emergent Adverse Events (TEAEs), Including Adverse Device Effects (ADEs) | From Visit 2 (Day 1) i.e., the day of the first IMD administration to Visit 5 - Final visit/Follow up - Day 31- 41 | Occurrence of Treatment-emergent adverse events (TEAEs), including adverse device effects (ADEs) assessed throughout the study after the first IMD administration. |
| Change From Baseline in Corneal Fluorescein Surface Staining (Oxford Score) | Visit 3 - Day 14±2, Visit 4 - Day 28±4, Visit 5 - Final visit/Follow up - Day 31- 41 | 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. |
| Change From Baseline in Schirmer's Test Type I (Without Anaesthesia) | Visit 3 - Day 14±2, Visit 4 - Day 28±4, Visit 5 - Final visit/Follow up - Day 31- 41 | 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 Schimer's test strip was removed and the length of the tear absorption on the strip was measured (millimeters/5 minutes). The longer the wetted length, the healthier the status of the eye. |
| Change From Baseline in Intraocular Pressure (IOP) | Visit 3 - Day 14±2, Visit 4 - Day 28±4, Visit 5 - Final visit/Follow up - Day 31- 41 | The IOP (intraocular pressure) of the eye was determined by the balance between the amount of aqueous humor that the eye marked and 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 SLEs to avoid potential interference with the other evaluations. Both eyes were tested. Normal eye pressure was between 10 to 21 mmHg. High ocular pressure was greater than 21 mmHg. |
| Change From Baseline in Slit Lamp Examination (SLE) Values | Visit 3 - Day 14±2, Visit 4 - Day 28±4, Visit 5 - Final visit/Follow up - Day 31- 41 | 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 (to 0-no opacification to 3-severe 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 vascularization to 4- neovascularization between 270° and 360°). The higher the score the worse the outcome. There was not a total score. |
Countries
Italy
Participant flow
Recruitment details
Recruitment was competitive between the study sites and continued until the planned number of randomised patients was achieved. Competitive recruitment was chosen to increase the speed of recruitment and to account for any difference in enrolment rate between study sites.
Pre-assignment details
Fifty-nine (59) subjects were screened and all of them were eligible for the investigation. Three (3) of the eligible subjects were not randomised and did not receive any treatment. So Fifty-six (56) subjects were randomised 1: 1 to Lubricin or Sodium Hyaluronate and used their assigned IMD at least once.
Participants by arm
| Arm | Count |
|---|---|
| Lubricin Lubricin 150 µg/ml eye drops. The test investigational device, as well as the comparator, was instilled q.i.d.(four times a day), one drop into each eye for 28±4 days. After the end of the treatment period, all the subjects used 0.13% Sodium hyaluronate eye drops q.i.d. for the following 7-9 days.
Before the start of the treatment (run-in period of 7 days), the subjects were allowed to use NaCl 0.9% ocular solution q.i.d.
Lubricin: Lubricin 150 µg/ml eye drops | 24 |
| Sodium Hyaluronate Sodium hyaluronate 0.13% eye drops. The comparator, as well as the test investigational device, was instilled q.i.d.(four times a day), one drop into each eye for 28±4 days. After the end of the treatment period, all the subjects used 0.13%Sodium hyaluronate eye drops q.i.d. for the following 7-9 days.
Before the start of the treatment (run-in period of 7 days), the subjects were allowed to use NaCl 0.9% ocular solution q.i.d.
Sodium Hyaluronate: Sodium hyaluronate 0.13% eye drops | 27 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Sodium Hyaluronate | Total | Lubricin |
|---|---|---|---|
| Age, Categorical PP population <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical PP population >=65 years | 10 Participants | 16 Participants | 6 Participants |
| Age, Categorical PP population Between 18 and 65 years | 17 Participants | 35 Participants | 18 Participants |
| Age, Continuous PP population | 57.7 years STANDARD_DEVIATION 12.9 | 57.7 years STANDARD_DEVIATION 11.7 | 57.6 years STANDARD_DEVIATION 10.6 |
| Race (NIH/OMB) PP population American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) PP population Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) PP population Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) PP population More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) PP population Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) PP population Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) PP population White | 27 Participants | 51 Participants | 24 Participants |
| Region of Enrollment Italy | 27 participants | 56 participants | 24 participants |
| Sex: Female, Male PP population Female | 24 Participants | 42 Participants | 18 Participants |
| Sex: Female, Male PP population Male | 3 Participants | 9 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 29 |
| other Total, other adverse events | 1 / 27 | 2 / 29 |
| serious Total, serious adverse events | 0 / 27 | 0 / 29 |
Outcome results
Primary
Change From Baseline (V2) in Frequency and Severity of Dry Eye Symptoms (SANDE) Questionnaire Scores at Day 28±4 (End of Treatment)
The SANDE (Symptom Assessment in Dry Eye) questionnaire was used to evaluate both dry eye frequency and severity using a 100 mm VAS line, representing ocular dryness and/or irritation at subject's level, according to their own perception, irrespective of the eye being or not the study eye, as per study Protocol. SANDE scores ranged from 0 (best condition) to 100 (worst condition) for both severity and frequency. The VAS score was determined - in millimeters - by measuring from the left-hand end to the marked point on the VAS line. SANDE OVERALL VAS score was calculated considering the mean and the SD of the Change from Baseline values at Day 14±2, Day 28±4 and Day 31-41, both for frequency and severity, and then calculated as square-root of the product of the two item score. Results are reported at the patient level, rather than focusing on a single eye, as the SANDE score assesses overall dry eye symptoms rather than eye-specific effects, as per study protocol.
Time frame: Visit 3 - Day 14±2, Visit 4 - Day 28±4, Visit 5 - Final visit/Follow up - Day 31- 41
Population: The Per Protocol set (PP) population included all enrolled subjects who fulfilled the investigation protocol requirements in terms of IMD intake (Lubricin or OcuYal®) during the treatment phase and collection of primary efficacy data and with no major deviations that could affect the results. This analysis set was used for the efficacy analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lubricin PP | Change From Baseline (V2) in Frequency and Severity of Dry Eye Symptoms (SANDE) Questionnaire Scores at Day 28±4 (End of Treatment) | Day 14±2 - Frequency | -11.9 mm | Standard Deviation 8.6 |
| Lubricin PP | Change From Baseline (V2) in Frequency and Severity of Dry Eye Symptoms (SANDE) Questionnaire Scores at Day 28±4 (End of Treatment) | Day 31-41 - Severity | -25.6 mm | Standard Deviation 16.6 |
| Lubricin PP | Change From Baseline (V2) in Frequency and Severity of Dry Eye Symptoms (SANDE) Questionnaire Scores at Day 28±4 (End of Treatment) | Day 14±2 - Severity | -10.6 mm | Standard Deviation 6 |
| Lubricin PP | Change From Baseline (V2) in Frequency and Severity of Dry Eye Symptoms (SANDE) Questionnaire Scores at Day 28±4 (End of Treatment) | Day 14±2 - Overall Score | -11.2 mm | Standard Deviation 6.9 |
| Lubricin PP | Change From Baseline (V2) in Frequency and Severity of Dry Eye Symptoms (SANDE) Questionnaire Scores at Day 28±4 (End of Treatment) | Day 31-41 - Frequency | -27.8 mm | Standard Deviation 14.5 |
| Lubricin PP | Change From Baseline (V2) in Frequency and Severity of Dry Eye Symptoms (SANDE) Questionnaire Scores at Day 28±4 (End of Treatment) | Day 28±4 - Overall score | -23.5 mm | Standard Deviation 11.9 |
| Lubricin PP | Change From Baseline (V2) in Frequency and Severity of Dry Eye Symptoms (SANDE) Questionnaire Scores at Day 28±4 (End of Treatment) | Day 28±4 - Severity | -22.2 mm | Standard Deviation 14.1 |
| Lubricin PP | Change From Baseline (V2) in Frequency and Severity of Dry Eye Symptoms (SANDE) Questionnaire Scores at Day 28±4 (End of Treatment) | Day 31-41 - Overall Score | -26.6 mm | Standard Deviation 13.4 |
| Lubricin PP | Change From Baseline (V2) in Frequency and Severity of Dry Eye Symptoms (SANDE) Questionnaire Scores at Day 28±4 (End of Treatment) | Day 28±4 -Frequency | -25.0 mm | Standard Deviation 12.2 |
| Sodium Hyaluronate PP | Change From Baseline (V2) in Frequency and Severity of Dry Eye Symptoms (SANDE) Questionnaire Scores at Day 28±4 (End of Treatment) | Day 31-41 - Overall Score | -28.3 mm | Standard Deviation 16.5 |
| Sodium Hyaluronate PP | Change From Baseline (V2) in Frequency and Severity of Dry Eye Symptoms (SANDE) Questionnaire Scores at Day 28±4 (End of Treatment) | Day 14±2 - Frequency | -16.6 mm | Standard Deviation 14.9 |
| Sodium Hyaluronate PP | Change From Baseline (V2) in Frequency and Severity of Dry Eye Symptoms (SANDE) Questionnaire Scores at Day 28±4 (End of Treatment) | Day 28±4 -Frequency | -26.5 mm | Standard Deviation 18 |
| Sodium Hyaluronate PP | Change From Baseline (V2) in Frequency and Severity of Dry Eye Symptoms (SANDE) Questionnaire Scores at Day 28±4 (End of Treatment) | Day 31-41 - Frequency | -30.9 mm | Standard Deviation 19.2 |
| Sodium Hyaluronate PP | Change From Baseline (V2) in Frequency and Severity of Dry Eye Symptoms (SANDE) Questionnaire Scores at Day 28±4 (End of Treatment) | Day 14±2 - Severity | -13.7 mm | Standard Deviation 12.8 |
| Sodium Hyaluronate PP | Change From Baseline (V2) in Frequency and Severity of Dry Eye Symptoms (SANDE) Questionnaire Scores at Day 28±4 (End of Treatment) | Day 28±4 - Severity | -21.8 mm | Standard Deviation 14.1 |
| Sodium Hyaluronate PP | Change From Baseline (V2) in Frequency and Severity of Dry Eye Symptoms (SANDE) Questionnaire Scores at Day 28±4 (End of Treatment) | Day 31-41 - Severity | -25.4 mm | Standard Deviation 14.5 |
| Sodium Hyaluronate PP | Change From Baseline (V2) in Frequency and Severity of Dry Eye Symptoms (SANDE) Questionnaire Scores at Day 28±4 (End of Treatment) | Day 14±2 - Overall Score | -15.3 mm | Standard Deviation 13.6 |
| Sodium Hyaluronate PP | Change From Baseline (V2) in Frequency and Severity of Dry Eye Symptoms (SANDE) Questionnaire Scores at Day 28±4 (End of Treatment) | Day 28±4 - Overall score | -24.2 mm | Standard Deviation 15.7 |
Comparison: Values at Day 28 ± 4 (end of treatment) for the SANDE overall VAS score were compared between treatment groups using a Student's t-test for unpaired data.Student t-test for unpaired data.
Secondary
Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) - ETDRS Score
Best corrected visual acuity (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 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 meters, the subject was tested at 1 meter. If 20 or more letters were read at 4 meters, the VAS for that eye was recorded as the number of letters correct at 4 meters plus 30. Otherwise, the VAS was the number of letters read correctly at 1 meter plus the number read at 4 meters. The higher the score the better the outcome.
Time frame: Visit 3 - Day 14±2, Visit 4 - Day 28±4, Visit 5 - Final visit/Follow up - Day 31- 41
Population: The Per Protocol set (PP) population included all enrolled subjects who fulfilled the investigation protocol requirements in terms of IMD intake (Lubricin or OcuYal®) during the treatment phase and collection of primary efficacy data and with no major deviations that could affect the results. This analysis set was used for the efficacy analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lubricin PP | Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) - ETDRS Score | Day 14±2 - Study eye | 0.0 score on a scale | Standard Deviation 1.2 |
| Lubricin PP | Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) - ETDRS Score | Day 14±2 -Non study eye | -0.2 score on a scale | Standard Deviation 0.8 |
| Lubricin PP | Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) - ETDRS Score | Day 28±4 - Study eye | 0.0 score on a scale | Standard Deviation 1.6 |
| Lubricin PP | Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) - ETDRS Score | Day 28±4 - Non study eye | 0.0 score on a scale | Standard Deviation 1.2 |
| Lubricin PP | Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) - ETDRS Score | Day 31-41 - Study eye | 0.1 score on a scale | Standard Deviation 1.8 |
| Lubricin PP | Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) - ETDRS Score | Day 31-41 - Non study eye | -0.3 score on a scale | Standard Deviation 1.3 |
| Sodium Hyaluronate PP | Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) - ETDRS Score | Day 31-41 - Study eye | -0.2 score on a scale | Standard Deviation 1.9 |
| Sodium Hyaluronate PP | Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) - ETDRS Score | Day 14±2 - Study eye | -0.1 score on a scale | Standard Deviation 1 |
| Sodium Hyaluronate PP | Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) - ETDRS Score | Day 28±4 - Non study eye | -0.4 score on a scale | Standard Deviation 1.8 |
| Sodium Hyaluronate PP | Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) - ETDRS Score | Day 14±2 -Non study eye | -0.3 score on a scale | Standard Deviation 1.3 |
| Sodium Hyaluronate PP | Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) - ETDRS Score | Day 31-41 - Non study eye | -0.5 score on a scale | Standard Deviation 1.8 |
| Sodium Hyaluronate PP | Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) - ETDRS Score | Day 28±4 - Study eye | -0.3 score on a scale | Standard Deviation 1.5 |
Comparison: Study Eye analytic statistic is presented. The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.p-value: 0.740895% CI: [-0.71, 0.51]ANOVA
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.
Time frame: Visit 3 - Day 14±2, Visit 4 - Day 28±4, Visit 5 - Final visit/Follow up - Day 31- 41
Population: The Per Protocol set (PP) population included all enrolled subjects who fulfilled the investigation protocol requirements in terms of IMD intake (Lubricin or OcuYal®) during the treatment phase and collection of primary efficacy data and with no major deviations that could affect the results. This analysis set was used for the efficacy analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lubricin PP | Change From Baseline in Corneal Fluorescein Surface Staining (Oxford Score) | Day 14±2 - Study eye | -0.3 score on a scale | Standard Deviation 0.4 |
| Lubricin PP | Change From Baseline in Corneal Fluorescein Surface Staining (Oxford Score) | Day 14±2 - Non study eye | -0.3 score on a scale | Standard Deviation 0.5 |
| Lubricin PP | Change From Baseline in Corneal Fluorescein Surface Staining (Oxford Score) | Day 28±4 - Study eye | -0.9 score on a scale | Standard Deviation 0.9 |
| Lubricin PP | Change From Baseline in Corneal Fluorescein Surface Staining (Oxford Score) | Day 28±4 - Non study eye | -0.7 score on a scale | Standard Deviation 0.6 |
| Lubricin PP | Change From Baseline in Corneal Fluorescein Surface Staining (Oxford Score) | Day 31-41 - Study eye | -1.0 score on a scale | Standard Deviation 0.9 |
| Lubricin PP | Change From Baseline in Corneal Fluorescein Surface Staining (Oxford Score) | Day 31-41 - Non study eye | -1.0 score on a scale | Standard Deviation 0.9 |
| Sodium Hyaluronate PP | Change From Baseline in Corneal Fluorescein Surface Staining (Oxford Score) | Day 31-41 - Study eye | -1.0 score on a scale | Standard Deviation 0.9 |
| Sodium Hyaluronate PP | Change From Baseline in Corneal Fluorescein Surface Staining (Oxford Score) | Day 14±2 - Study eye | -0.4 score on a scale | Standard Deviation 0.6 |
| Sodium Hyaluronate PP | Change From Baseline in Corneal Fluorescein Surface Staining (Oxford Score) | Day 28±4 - Non study eye | -0.7 score on a scale | Standard Deviation 0.9 |
| Sodium Hyaluronate PP | Change From Baseline in Corneal Fluorescein Surface Staining (Oxford Score) | Day 14±2 - Non study eye | -0.5 score on a scale | Standard Deviation 0.8 |
| Sodium Hyaluronate PP | Change From Baseline in Corneal Fluorescein Surface Staining (Oxford Score) | Day 31-41 - Non study eye | -0.7 score on a scale | Standard Deviation 1 |
| Sodium Hyaluronate PP | Change From Baseline in Corneal Fluorescein Surface Staining (Oxford Score) | Day 28±4 - Study eye | -0.8 score on a scale | Standard Deviation 0.9 |
Comparison: Study eye analytic statistic is presented.The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.p-value: 0.836395% CI: [-0.26, 0.21]ANOVA
Secondary
Change From Baseline in Intraocular Pressure (IOP)
The IOP (intraocular pressure) of the eye was determined by the balance between the amount of aqueous humor that the eye marked and 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 SLEs to avoid potential interference with the other evaluations. Both eyes were tested. Normal eye pressure was between 10 to 21 mmHg. High ocular pressure was greater than 21 mmHg.
Time frame: Visit 3 - Day 14±2, Visit 4 - Day 28±4, Visit 5 - Final visit/Follow up - Day 31- 41
Population: The Per Protocol set (PP) population included all enrolled subjects who fulfilled the investigation protocol requirements in terms of IMD intake (Lubricin or OcuYal®) during the treatment phase and collection of primary efficacy data and with no major deviations that could affect the results. This analysis set was used for the efficacy analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lubricin PP | Change From Baseline in Intraocular Pressure (IOP) | Day 14±2 - Study eye | 0.7 mmHg | Standard Deviation 1.9 |
| Lubricin PP | Change From Baseline in Intraocular Pressure (IOP) | Day 14±2 - Non study eye | -0.4 mmHg | Standard Deviation 2.1 |
| Lubricin PP | Change From Baseline in Intraocular Pressure (IOP) | Day 28±4 - Study eye | -0.2 mmHg | Standard Deviation 1.8 |
| Lubricin PP | Change From Baseline in Intraocular Pressure (IOP) | Day 28±4 - Non study eye | -0.3 mmHg | Standard Deviation 1.7 |
| Lubricin PP | Change From Baseline in Intraocular Pressure (IOP) | Day 31-41 - Study eye | -0.8 mmHg | Standard Deviation 2.6 |
| Lubricin PP | Change From Baseline in Intraocular Pressure (IOP) | Day 31-41 - Non study eye | -0.5 mmHg | Standard Deviation 2.5 |
| Sodium Hyaluronate PP | Change From Baseline in Intraocular Pressure (IOP) | Day 31-41 - Study eye | -0.9 mmHg | Standard Deviation 2.5 |
| Sodium Hyaluronate PP | Change From Baseline in Intraocular Pressure (IOP) | Day 14±2 - Study eye | -0.6 mmHg | Standard Deviation 2.1 |
| Sodium Hyaluronate PP | Change From Baseline in Intraocular Pressure (IOP) | Day 28±4 - Non study eye | 0.1 mmHg | Standard Deviation 2.6 |
| Sodium Hyaluronate PP | Change From Baseline in Intraocular Pressure (IOP) | Day 14±2 - Non study eye | -0.2 mmHg | Standard Deviation 1.9 |
| Sodium Hyaluronate PP | Change From Baseline in Intraocular Pressure (IOP) | Day 31-41 - Non study eye | -0.2 mmHg | Standard Deviation 2.6 |
| Sodium Hyaluronate PP | Change From Baseline in Intraocular Pressure (IOP) | Day 28±4 - Study eye | -0.4 mmHg | Standard Deviation 2.5 |
Comparison: Study eye analytic statistic is presented.The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline (Visit 2 - Day 1) across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.p-value: 0.615395% CI: [-0.82, 0.49]ANOVA
Secondary
Change From Baseline in Permanence of Lubricin on the Ocular Surface - Tear Film Break-up Time (TFBUT)
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. The higher the value, the better the outcome.
Time frame: Visit 3 - Day 14±2, Visit 4 - Day 28±4, Visit 5 - Final visit/Follow up - Day 31- 41
Population: The Per Protocol set (PP) population included all enrolled subjects who fulfilled the investigation protocol requirements in terms of IMD intake (Lubricin or OcuYal®) during the treatment phase and collection of primary efficacy data and with no major deviations that could affect the results. This analysis set was used for the efficacy analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lubricin PP | Change From Baseline in Permanence of Lubricin on the Ocular Surface - Tear Film Break-up Time (TFBUT) | Day 14±2 - Study eye | 1.0 seconds | Standard Deviation 2 |
| Lubricin PP | Change From Baseline in Permanence of Lubricin on the Ocular Surface - Tear Film Break-up Time (TFBUT) | Day 14±2 - Non study eye | 0.6 seconds | Standard Deviation 2.7 |
| Lubricin PP | Change From Baseline in Permanence of Lubricin on the Ocular Surface - Tear Film Break-up Time (TFBUT) | Day 28±4 - Study eye | 1.3 seconds | Standard Deviation 2.1 |
| Lubricin PP | Change From Baseline in Permanence of Lubricin on the Ocular Surface - Tear Film Break-up Time (TFBUT) | Day 28±4 - Non study eye | 0.3 seconds | Standard Deviation 2.8 |
| Lubricin PP | Change From Baseline in Permanence of Lubricin on the Ocular Surface - Tear Film Break-up Time (TFBUT) | Day 31-41 - Study eye | 0.5 seconds | Standard Deviation 1.8 |
| Lubricin PP | Change From Baseline in Permanence of Lubricin on the Ocular Surface - Tear Film Break-up Time (TFBUT) | Day 31-41 - Non study eye | 0.5 seconds | Standard Deviation 2.5 |
| Sodium Hyaluronate PP | Change From Baseline in Permanence of Lubricin on the Ocular Surface - Tear Film Break-up Time (TFBUT) | Day 31-41 - Study eye | 1.0 seconds | Standard Deviation 1.8 |
| Sodium Hyaluronate PP | Change From Baseline in Permanence of Lubricin on the Ocular Surface - Tear Film Break-up Time (TFBUT) | Day 14±2 - Study eye | 1.1 seconds | Standard Deviation 2.5 |
| Sodium Hyaluronate PP | Change From Baseline in Permanence of Lubricin on the Ocular Surface - Tear Film Break-up Time (TFBUT) | Day 28±4 - Non study eye | 2.5 seconds | Standard Deviation 2.8 |
| Sodium Hyaluronate PP | Change From Baseline in Permanence of Lubricin on the Ocular Surface - Tear Film Break-up Time (TFBUT) | Day 14±2 - Non study eye | 1.6 seconds | Standard Deviation 2.6 |
| Sodium Hyaluronate PP | Change From Baseline in Permanence of Lubricin on the Ocular Surface - Tear Film Break-up Time (TFBUT) | Day 31-41 - Non study eye | 1.4 seconds | Standard Deviation 2 |
| Sodium Hyaluronate PP | Change From Baseline in Permanence of Lubricin on the Ocular Surface - Tear Film Break-up Time (TFBUT) | Day 28±4 - Study eye | 1.9 seconds | Standard Deviation 2.7 |
Comparison: Study Eye analytic statistic is presented. The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.p-value: 0.859695% CI: [-0.78, 0.87]ANOVA
Secondary
Change From Baseline in Schirmer's Test Type 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 Schimer's test strip was removed and the length of the tear absorption on the strip was measured (millimeters/5 minutes). The longer the wetted length, the healthier the status of the eye.
Time frame: Visit 3 - Day 14±2, Visit 4 - Day 28±4, Visit 5 - Final visit/Follow up - Day 31- 41
Population: The Per Protocol set (PP) population included all enrolled subjects who fulfilled the investigation protocol requirements in terms of IMD intake (Lubricin or OcuYal®) during the treatment phase and collection of primary efficacy data and with no major deviations that could affect the results. This analysis set was used for the efficacy analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lubricin PP | Change From Baseline in Schirmer's Test Type I (Without Anaesthesia) | Day 14±2 - Non study eye | 0.9 mm/5min | Standard Deviation 2.5 |
| Lubricin PP | Change From Baseline in Schirmer's Test Type I (Without Anaesthesia) | Day 14±2 - Study eye | 0.7 mm/5min | Standard Deviation 2.4 |
| Lubricin PP | Change From Baseline in Schirmer's Test Type I (Without Anaesthesia) | Day 31-41 - Study eye | 0.5 mm/5min | Standard Deviation 1.9 |
| Lubricin PP | Change From Baseline in Schirmer's Test Type I (Without Anaesthesia) | Day 28±4 - Study eye | 1.2 mm/5min | Standard Deviation 3.6 |
| Lubricin PP | Change From Baseline in Schirmer's Test Type I (Without Anaesthesia) | Day 31-41 - Non study eye | 0.4 mm/5min | Standard Deviation 1.6 |
| Lubricin PP | Change From Baseline in Schirmer's Test Type I (Without Anaesthesia) | Day 28±4 - Non study eye | 1.1 mm/5min | Standard Deviation 3.2 |
| Sodium Hyaluronate PP | Change From Baseline in Schirmer's Test Type I (Without Anaesthesia) | Day 31-41 - Non study eye | 0.7 mm/5min | Standard Deviation 2.3 |
| Sodium Hyaluronate PP | Change From Baseline in Schirmer's Test Type I (Without Anaesthesia) | Day 14±2 - Study eye | 1.0 mm/5min | Standard Deviation 2.8 |
| Sodium Hyaluronate PP | Change From Baseline in Schirmer's Test Type I (Without Anaesthesia) | Day 14±2 - Non study eye | 1.5 mm/5min | Standard Deviation 3.1 |
| Sodium Hyaluronate PP | Change From Baseline in Schirmer's Test Type I (Without Anaesthesia) | Day 28±4 - Study eye | 0.9 mm/5min | Standard Deviation 2.5 |
| Sodium Hyaluronate PP | Change From Baseline in Schirmer's Test Type I (Without Anaesthesia) | Day 28±4 - Non study eye | 1.5 mm/5min | Standard Deviation 2.6 |
| Sodium Hyaluronate PP | Change From Baseline in Schirmer's Test Type I (Without Anaesthesia) | Day 31-41 - Study eye | 0.3 mm/5min | Standard Deviation 2 |
Comparison: Study eye analytic statistic is presented.The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline (Visit 2 - Day 1) across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.p-value: 0.624895% CI: [-0.62, 1.02]ANOVA
Secondary
Change From Baseline in Slit Lamp Examination (SLE) Values
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 (to 0-no opacification to 3-severe 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 vascularization to 4- neovascularization between 270° and 360°). The higher the score the worse the outcome. There was not a total score.
Time frame: Visit 3 - Day 14±2, Visit 4 - Day 28±4, Visit 5 - Final visit/Follow up - Day 31- 41
Population: The Per Protocol set (PP) population included all enrolled subjects who fulfilled the investigation protocol requirements in terms of IMD intake (Lubricin or OcuYal®) during the treatment phase and collection of primary efficacy data and with no major deviations that could affect the results. This analysis set was used for the efficacy analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Iris - Study eye - Day 14±2 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Eyelid - Oedema - Non study eye - Day 14±2 | -0.2 score on a scale | Standard Deviation 0.4 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Lens - Study eye - Day 28±4 | 0.0 score on a scale | Standard Deviation 0.2 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Eyelid - Meibomian gland - Non study eye - Day 14±2 | -0.5 score on a scale | Standard Deviation 0.6 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Lens - Non study eye - Day 28±4 | 0.0 score on a scale | Standard Deviation 0.2 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Anterior chamber inflammation - Study eye - Day 14±2 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Iris - Study eye - Day 28±4 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Lashes - Study eye - Day 14±2 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Iris - Non study eye - Day 28±4 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Anterior chamber inflammation - Non study eye - Day 14±2 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Anterior chamber inflammation - Study eye - Day 28±4 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Eyelid - erythema - Study eye - Day 28±4 | -0.5 score on a scale | Standard Deviation 0.7 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Anterior chamber inflammation - Non study eye - Day 28±4 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Cornea transparency - Study eye - Day 14±2 | 0.0 score on a scale | Standard Deviation 0.2 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Cornea tranparency - Study eye - Day 28±4 | 0.0 score on a scale | Standard Deviation 0.2 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Lashes - Non study eye - Day 14±2 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Cornea tranparency - Non study eye - Day 28±4 | 0.0 score on a scale | Standard Deviation 0.2 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Cornea transparency - Non study eye - Day 14±2 | 0.0 score on a scale | Standard Deviation 0.2 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Cornea neovascularization - Study eye - Day 28±4 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Eyelid - Erythema - Study eye - Day 14±2 | -0.3 score on a scale | Standard Deviation 0.6 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Cornea neovascularization - Non study eye - Day 28±4 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Cornea neovascularisation - Study eye - Day 14±2 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Eyelid - Meibomian gland - Study eye - Day 31-41 | -0.6 score on a scale | Standard Deviation 0.8 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Conjunctiva - Erythema - Study eye - Day 14±2 | -0.4 score on a scale | Standard Deviation 0.6 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Eyelid - Meibomian gland - Non study eye - Day 31-41 | -0.7 score on a scale | Standard Deviation 0.9 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Cornea neovascularisation - Non study eye - Day 14±2 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Eyelid - erythema - Study eye - Day 31-41 | -0.6 score on a scale | Standard Deviation 0.7 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Conjunctiva - Oedema - Non study eye - Day 28±4 | 0.0 score on a scale | Standard Deviation 0.7 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Eyelid - erythema - Non study eye - Day 31-41 | -0.6 score on a scale | Standard Deviation 0.9 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Eyelid - Meibomian gland - Study eye - Day 28±4 | -0.5 score on a scale | Standard Deviation 0.7 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Eyelid - Oedema - Study eye - Day 31-41 | -0.4 score on a scale | Standard Deviation 0.7 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Conjunctiva - Erythema - Non study eye - Day 14±2 | -0.3 score on a scale | Standard Deviation 0.6 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Eyelid - Oedema - Non study eye - Day 31-41 | -0.3 score on a scale | Standard Deviation 0.9 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Eyelid - Meibomian gland - Non study eye -Day 28±4 | -0.5 score on a scale | Standard Deviation 0.8 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Lashes - Study eye - Day 31-41 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Eyelid - Erythema - Non study eye - Day 14±2 | -0.2 score on a scale | Standard Deviation 0.6 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Lashes - Non study eye - Day 31-41 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Eyelid - Meibomian gland - Study eye - Day 14±2 | -0.5 score on a scale | Standard Deviation 0.6 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Conjunctiva - erythema - Study eye - Day 31-41 | -0.8 score on a scale | Standard Deviation 1 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Eyelid - erythema - Non study eye - Day 28±4 | -0.5 score on a scale | Standard Deviation 0.9 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Conjunctiva - erythema - Non study eye - Day 31-41 | -0.5 score on a scale | Standard Deviation 1 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Conjunctiva - Oedema - Non study eye - Day 14±2 | -0.1 score on a scale | Standard Deviation 0.5 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Conjunctiva - Oedema - Study eye - Day 31-41 | -0.1 score on a scale | Standard Deviation 0.9 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Eyelid - Oedema - Study eye - Day 28±4 | -0.3 score on a scale | Standard Deviation 0.8 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Conjunctiva - Oedema - Non study eye - Day 31-41 | 0.0 score on a scale | Standard Deviation 0.8 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Eyelid - Oedema - Non study eye - Day 28±4 | -0.3 score on a scale | Standard Deviation 0.7 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Lens - Study eye - Day 31-41 | 0.0 score on a scale | Standard Deviation 0.2 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Eyelid - Oedema - Study eye - Day 14±2 | -0.2 score on a scale | Standard Deviation 0.5 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Lens - Non study eye - Day 31-41 | 0.0 score on a scale | Standard Deviation 0.2 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Lashes - Study eye - Day 28±4 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Iris - Study eye - Day 31-41 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Lens - Study eye - Day 14±2 | 0.0 score on a scale | Standard Deviation 0.2 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Iris - Non study eye - Day 31-41 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Lashes - Non study eye - Day 28±4 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Anterior chamber inflammation - Study eye - Day 31-41 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Lens - Non study eye - Day 14±2 | 0.0 score on a scale | Standard Deviation 0.2 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Anterior chamber inflammation - Non study eye - Day 31-41 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Conjunctiva - erythema - Study eye - Day 28±4 | -0.6 score on a scale | Standard Deviation 0.8 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Cornea transparency - Study eye - Day 31-41 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Conjunctiva - erythema - Non study eye - Day 28±4 | -0.4 score on a scale | Standard Deviation 0.9 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Cornea transparency - Non study eye - Day 31-41 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Iris - Non study eye - Day 14±2 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Cornea neovascularization - Study eye - Day 31-41 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Conjunctiva - Oedema - Study eye - Day 28±4 | -0.2 score on a scale | Standard Deviation 0.7 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Cornea neovascularization - Non study eye - Day 31-41 | 0.0 score on a scale | Standard Deviation 0 |
| Lubricin PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Conjunctiva - Oedema - Study eye - Day 14±2 | 0.0 score on a scale | Standard Deviation 0.5 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Cornea neovascularization - Non study eye - Day 31-41 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Lens - Study eye - Day 14±2 | 0.0 score on a scale | Standard Deviation 0.3 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Eyelid - Oedema - Study eye - Day 28±4 | -0.3 score on a scale | Standard Deviation 0.8 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Conjunctiva - erythema - Study eye - Day 28±4 | -0.6 score on a scale | Standard Deviation 0.8 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Eyelid - Meibomian gland - Study eye - Day 14±2 | -0.4 score on a scale | Standard Deviation 0.5 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Eyelid - Meibomian gland - Non study eye - Day 14±2 | -0.4 score on a scale | Standard Deviation 0.6 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Eyelid - Erythema - Study eye - Day 14±2 | -0.4 score on a scale | Standard Deviation 0.7 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Eyelid - Erythema - Non study eye - Day 14±2 | -0.4 score on a scale | Standard Deviation 0.7 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Eyelid - Oedema - Study eye - Day 14±2 | -0.1 score on a scale | Standard Deviation 0.6 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Eyelid - Oedema - Non study eye - Day 14±2 | -0.1 score on a scale | Standard Deviation 0.5 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Lashes - Study eye - Day 14±2 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Lashes - Non study eye - Day 14±2 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Conjunctiva - Erythema - Study eye - Day 14±2 | -0.4 score on a scale | Standard Deviation 0.7 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Conjunctiva - Erythema - Non study eye - Day 14±2 | -0.4 score on a scale | Standard Deviation 0.8 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Conjunctiva - Oedema - Study eye - Day 14±2 | -0.1 score on a scale | Standard Deviation 0.7 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Conjunctiva - Oedema - Non study eye - Day 14±2 | -0.1 score on a scale | Standard Deviation 0.6 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Lens - Non study eye - Day 14±2 | 0.0 score on a scale | Standard Deviation 0.2 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Iris - Study eye - Day 14±2 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Iris - Non study eye - Day 14±2 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Anterior chamber inflammation - Study eye - Day 14±2 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Anterior chamber inflammation - Non study eye - Day 14±2 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Cornea transparency - Study eye - Day 14±2 | 0.0 score on a scale | Standard Deviation 0.2 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Cornea transparency - Non study eye - Day 14±2 | 0.0 score on a scale | Standard Deviation 0.2 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Cornea neovascularisation - Study eye - Day 14±2 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Cornea neovascularisation - Non study eye - Day 14±2 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Eyelid - Meibomian gland - Study eye - Day 28±4 | -0.7 score on a scale | Standard Deviation 0.7 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Eyelid - Meibomian gland - Non study eye -Day 28±4 | -0.6 score on a scale | Standard Deviation 0.7 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Eyelid - erythema - Study eye - Day 28±4 | -0.4 score on a scale | Standard Deviation 0.8 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Eyelid - erythema - Non study eye - Day 28±4 | -0.4 score on a scale | Standard Deviation 0.8 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Eyelid - Oedema - Non study eye - Day 28±4 | -0.2 score on a scale | Standard Deviation 0.7 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Lashes - Study eye - Day 28±4 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Lashes - Non study eye - Day 28±4 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Conjunctiva - erythema - Non study eye - Day 28±4 | -0.5 score on a scale | Standard Deviation 0.9 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Conjunctiva - Oedema - Study eye - Day 28±4 | 0.0 score on a scale | Standard Deviation 0.8 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Conjunctiva - Oedema - Non study eye - Day 28±4 | -0.1 score on a scale | Standard Deviation 0.8 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Lens - Study eye - Day 28±4 | 0.0 score on a scale | Standard Deviation 0.3 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Lens - Non study eye - Day 28±4 | 0.0 score on a scale | Standard Deviation 0.2 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Iris - Study eye - Day 28±4 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Iris - Non study eye - Day 28±4 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Anterior chamber inflammation - Study eye - Day 28±4 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Anterior chamber inflammation - Non study eye - Day 28±4 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Cornea tranparency - Study eye - Day 28±4 | 0.0 score on a scale | Standard Deviation 0.2 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Cornea tranparency - Non study eye - Day 28±4 | 0.0 score on a scale | Standard Deviation 0.2 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Cornea neovascularization - Study eye - Day 28±4 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Cornea neovascularization - Non study eye - Day 28±4 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Eyelid - Meibomian gland - Study eye - Day 31-41 | -0.9 score on a scale | Standard Deviation 0.8 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Eyelid - Meibomian gland - Non study eye - Day 31-41 | -0.7 score on a scale | Standard Deviation 0.8 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Eyelid - erythema - Study eye - Day 31-41 | -0.6 score on a scale | Standard Deviation 0.8 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Eyelid - erythema - Non study eye - Day 31-41 | -0.4 score on a scale | Standard Deviation 0.8 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Eyelid - Oedema - Study eye - Day 31-41 | 0.0 score on a scale | Standard Deviation 0.6 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Eyelid - Oedema - Non study eye - Day 31-41 | 0.0 score on a scale | Standard Deviation 0.6 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Lashes - Study eye - Day 31-41 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Lashes - Non study eye - Day 31-41 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Conjunctiva - erythema - Study eye - Day 31-41 | -0.4 score on a scale | Standard Deviation 1 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Conjunctiva - erythema - Non study eye - Day 31-41 | -0.4 score on a scale | Standard Deviation 0.9 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Conjunctiva - Oedema - Study eye - Day 31-41 | 0.0 score on a scale | Standard Deviation 0.9 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Conjunctiva - Oedema - Non study eye - Day 31-41 | -0.1 score on a scale | Standard Deviation 0.9 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Lens - Study eye - Day 31-41 | 0.0 score on a scale | Standard Deviation 0.4 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Lens - Non study eye - Day 31-41 | -0.1 score on a scale | Standard Deviation 0.3 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Iris - Study eye - Day 31-41 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Iris - Non study eye - Day 31-41 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Anterior chamber inflammation - Study eye - Day 31-41 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Anterior chamber inflammation - Non study eye - Day 31-41 | 0.0 score on a scale | Standard Deviation 0 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Cornea transparency - Study eye - Day 31-41 | 0.0 score on a scale | Standard Deviation 0.2 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Cornea transparency - Non study eye - Day 31-41 | 0.0 score on a scale | Standard Deviation 0.2 |
| Sodium Hyaluronate PP | Change From Baseline in Slit Lamp Examination (SLE) Values | Cornea neovascularization - Study eye - Day 31-41 | 0.0 score on a scale | Standard Deviation 0 |
Comparison: Eyelid - Meibomian glands in Study eye analytic statistic is presented. The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.p-value: 0.789195% CI: [-0.16, 0.2]ANOVA
Comparison: Eyelid - Erythema in Study eye analytic statistic is presented. The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.p-value: 0.607595% CI: [-0.24, 0.14]ANOVA
Comparison: Eyelid - Oedema in Study eye analytic statistic is presented.The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.p-value: 0.663995% CI: [-0.14, 0.21]ANOVA
Comparison: Conjunctiva - Erythema in Study eye analytic statistic is presented.The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value is not duplicated or triplicated, reflecting the global outcome consistent with repeated measures ANOVA methodology.p-value: 0.348295% CI: [-0.1, 0.29]ANOVA
Comparison: Conjunctiva - Oedema in Study eye analytic statistic is presented.The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline (Visit 2 - Day 1) across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.p-value: 0.242295% CI: [-0.34, 0.09]ANOVA
Comparison: Lens in Study eye analytic statistic is presented.The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.p-value: 0.864595% CI: [-0.11, 0.14]ANOVA
Comparison: Cornea transparency in Study eye analytic statistic is presented.The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.p-value: 0.37995% CI: [-0.11, 0.04]ANOVA
Secondary
Change From Baseline in Tear Film Osmolarity
Tear film osmolarity as a marker of tear film solute content was performed with a TearLab Osmolarity System. The concentration of the tears was assessed in both eyes before the instillation of any dilating or anaesthetic drops. The tear fluid was collected onto the bottom tip of the test card by passive capillary action. After a successful tear collection, the Pen was docked into the Reader, which showed the quantitative tear film osmolarity result in mOsm/L on the liquid crystal display. Normal Patients: 275-316 mOsms/L (mean 302 mOsms/L), Dry Eye Disease Patients: \> 316 mOsms/L. The higher the score the worst the outcome.
Time frame: Visit 3 - Day 14±2, Visit 4 - Day 28±4, Visit 5 - Final visit/Follow up - Day 31- 41
Population: The Per Protocol set (PP) population included all enrolled subjects who fulfilled the investigation protocol requirements in terms of IMD intake (Lubricin or OcuYal®) during the treatment phase and collection of primary efficacy data and with no major deviations that could affect the results. This analysis set was used for the efficacy analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lubricin PP | Change From Baseline in Tear Film Osmolarity | Day 14±2 - Non Study eye | -10.3 mOsm /L | Standard Deviation 8.4 |
| Lubricin PP | Change From Baseline in Tear Film Osmolarity | Day 28±4 - Non study eye | -10.8 mOsm /L | Standard Deviation 11.4 |
| Lubricin PP | Change From Baseline in Tear Film Osmolarity | Day 14±2 - Study eye | -9.6 mOsm /L | Standard Deviation 15 |
| Lubricin PP | Change From Baseline in Tear Film Osmolarity | Day 28±4 - Study eye | -7.0 mOsm /L | Standard Deviation 24.4 |
| Lubricin PP | Change From Baseline in Tear Film Osmolarity | Day 31-41 - Non study eye | -7.8 mOsm /L | Standard Deviation 8 |
| Lubricin PP | Change From Baseline in Tear Film Osmolarity | Day 31-41 - Study eye | -7.6 mOsm /L | Standard Deviation 14.4 |
| Sodium Hyaluronate PP | Change From Baseline in Tear Film Osmolarity | Day 31-41 - Non study eye | -11.2 mOsm /L | Standard Deviation 11.5 |
| Sodium Hyaluronate PP | Change From Baseline in Tear Film Osmolarity | Day 14±2 - Study eye | -12.7 mOsm /L | Standard Deviation 11.8 |
| Sodium Hyaluronate PP | Change From Baseline in Tear Film Osmolarity | Day 14±2 - Non Study eye | -12.1 mOsm /L | Standard Deviation 11.5 |
| Sodium Hyaluronate PP | Change From Baseline in Tear Film Osmolarity | Day 28±4 - Study eye | -12.4 mOsm /L | Standard Deviation 11.3 |
| Sodium Hyaluronate PP | Change From Baseline in Tear Film Osmolarity | Day 28±4 - Non study eye | -12.7 mOsm /L | Standard Deviation 13 |
| Sodium Hyaluronate PP | Change From Baseline in Tear Film Osmolarity | Day 31-41 - Study eye | -9.2 mOsm /L | Standard Deviation 10.2 |
Comparison: Study Eye analytic statistic is presented. The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.p-value: 0.648495% CI: [-5.07, 3.19]ANOVA
Secondary
Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (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 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 extreme limits of the parameter.
Time frame: Visit 3 - Day 14±2, Visit 4 - Day 28±4, Visit 5 - Final visit/Follow up - Day 31- 41
Population: The Per Protocol set (PP) population included all enrolled subjects who fulfilled the investigation protocol requirements in terms of IMD intake (Lubricin or OcuYal®) during the treatment phase and collection of primary efficacy data and with no major deviations that could affect the results. This analysis set was used for the efficacy analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lubricin PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Photophobia - Study eye - Day 14±2 | -19.5 mm | Standard Deviation 17.3 |
| Lubricin PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Foreign Body sensation - Non Study eye -Day 14±2 | -9.4 mm | Standard Deviation 10.8 |
| Lubricin PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Burning /Stinging - Study eye - Day 14±2 | -15.9 mm | Standard Deviation 13.5 |
| Lubricin PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Burning /Stinging - Non Study eye - Day 14±2 | -8.9 mm | Standard Deviation 12.1 |
| Lubricin PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Itching - Study eye - Day 14±2 | -15.7 mm | Standard Deviation 12.7 |
| Lubricin PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Itching - Non Study eye - Day 14±2 | -10.9 mm | Standard Deviation 15.7 |
| Lubricin PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Pain - Study eye - Day 14±2 | -13.7 mm | Standard Deviation 13 |
| Lubricin PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Pain - Non Study eye - Day 14±2 | -8.2 mm | Standard Deviation 12.8 |
| Lubricin PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Sticky feeling- Study eye - Day 14±2 | -13.5 mm | Standard Deviation 12.5 |
| Lubricin PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Sticky feeling- Non Study eye - Day 14±2 | -11.2 mm | Standard Deviation 9.8 |
| Lubricin PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Blurred vision- Study eye - Day 14±2 | -11.3 mm | Standard Deviation 16.1 |
| Lubricin PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Blurred vision- Non Study eye - Day 14±2 | -9.1 mm | Standard Deviation 14.5 |
| Lubricin PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Foreign Body sensation - Study eye -Day 14±2 | -12.6 mm | Standard Deviation 11.4 |
| Lubricin PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Photophobia - Non Study eye - Day 14±2 | -11.7 mm | Standard Deviation 13.4 |
| Lubricin PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Total score - Study eye - Day 14±2 | -102.2 mm | Standard Deviation 64.2 |
| Lubricin PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Total score - Non Study eye - Day 14±2 | -69.5 mm | Standard Deviation 48.9 |
| Lubricin PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Foreign Body sensation - Study eye -Day 28±4 | -25.0 mm | Standard Deviation 17.6 |
| Lubricin PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Foreign Body sensation - Non Study eye -Day 28±4 | -17.0 mm | Standard Deviation 17.3 |
| Lubricin PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Burning /Stinging - Study eye - Day 28±4 | -27.6 mm | Standard Deviation 18.36 |
| Lubricin PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Burning /Stinging - Non Study eye - Day 28±4 | -14.6 mm | Standard Deviation 16.3 |
| Lubricin PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Itching - Study eye - Day 28±4 | -27.6 mm | Standard Deviation 18.5 |
| Lubricin PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Itching - Non Study eye - Day 28±4 | -19.3 mm | Standard Deviation 16.8 |
| Lubricin PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Pain - Study eye - Day 28±4 | -24.1 mm | Standard Deviation 18.4 |
| Lubricin PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Pain - Non Study eye - Day 28±4 | -15.0 mm | Standard Deviation 18.8 |
| Lubricin PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Sticky feeling- Study eye - Day 28±4 | -21.9 mm | Standard Deviation 18.6 |
| Lubricin PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Sticky feeling - Non Study eye - Day 28±4 | -17.6 mm | Standard Deviation 19.4 |
| Lubricin PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Blurred vision - Study eye - Day 28±4 | -14.0 mm | Standard Deviation 19.4 |
| Lubricin PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Blurred vision - Non Study eye - Day 28±4 | -13.4 mm | Standard Deviation 18.6 |
| Lubricin PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Photophobia - Study eye - Day 28±4 | -28.8 mm | Standard Deviation 25.1 |
| Lubricin PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Photophobia - Non Study eye - Day 28±4 | -17.1 mm | Standard Deviation 27.1 |
| Lubricin PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Total score - Study eye - Day 28±4 | -168.9 mm | Standard Deviation 82.8 |
| Lubricin PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Total score - Non Study eye - Day 28±4 | -114.1 mm | Standard Deviation 74.3 |
| Lubricin PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Foreign Body sensation - Study eye - Day 31-41 | -28.3 mm | Standard Deviation 21.8 |
| Lubricin PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Foreign Body sensation - Non study eye - Day 31-41 | -19.7 mm | Standard Deviation 15.8 |
| Lubricin PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Burning/Stinging -Study eye -Day 31-41 | -30.5 mm | Standard Deviation 23.5 |
| Lubricin PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Burning/Stinging - Non study eye - Day 31-41 | -11.1 mm | Standard Deviation 19.2 |
| Lubricin PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Itching - Study eye - Day 31-41 | -28.6 mm | Standard Deviation 22.9 |
| Lubricin PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Itching - Non study eye - Day 31-41 | -18.9 mm | Standard Deviation 17.5 |
| Lubricin PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Pain - Study eye - Day 31-41 | -26.9 mm | Standard Deviation 20.1 |
| Lubricin PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Pain - Non study eye - Day 31-41 | -12.0 mm | Standard Deviation 21.7 |
| Lubricin PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Sticky feeling - Study eye - Day 31-41 | -20.5 mm | Standard Deviation 23.1 |
| Lubricin PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Sticky feeling - Non study eye - Day 31-41 | -21.4 mm | Standard Deviation 21.8 |
| Lubricin PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Blurred vision - Study eye - Day 31-41 | -14.6 mm | Standard Deviation 19.4 |
| Lubricin PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Blurred vision - Non study eye - Day 31-41 | -10.9 mm | Standard Deviation 19.8 |
| Lubricin PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Photophobia - Study eye - Day 31-41 | -25.3 mm | Standard Deviation 25.1 |
| Lubricin PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Photophobia - Non study eye - Day 31-41 | -17.6 mm | Standard Deviation 27.5 |
| Lubricin PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Total score - Study eye - Day 31-41 | -174.8 mm | Standard Deviation 96 |
| Lubricin PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Total score - Non study eye - Day 31-41 | -11.5 mm | Standard Deviation 86.2 |
| Sodium Hyaluronate PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Total score - Study eye - Day 31-41 | -145.1 mm | Standard Deviation 102.2 |
| Sodium Hyaluronate PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Foreign Body sensation - Study eye -Day 14±2 | -16.2 mm | Standard Deviation 15.4 |
| Sodium Hyaluronate PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Sticky feeling- Study eye - Day 28±4 | -13.1 mm | Standard Deviation 21.5 |
| Sodium Hyaluronate PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Foreign Body sensation - Non Study eye -Day 14±2 | -11.7 mm | Standard Deviation 10.4 |
| Sodium Hyaluronate PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Itching - Study eye - Day 31-41 | -19.1 mm | Standard Deviation 21.4 |
| Sodium Hyaluronate PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Burning /Stinging - Study eye - Day 14±2 | -15.7 mm | Standard Deviation 17.2 |
| Sodium Hyaluronate PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Sticky feeling - Non Study eye - Day 28±4 | -9.2 mm | Standard Deviation 18 |
| Sodium Hyaluronate PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Burning /Stinging - Non Study eye - Day 14±2 | -8.6 mm | Standard Deviation 10.1 |
| Sodium Hyaluronate PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Blurred vision - Study eye - Day 31-41 | -15.3 mm | Standard Deviation 23.9 |
| Sodium Hyaluronate PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Itching - Study eye - Day 14±2 | -10.9 mm | Standard Deviation 15 |
| Sodium Hyaluronate PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Blurred vision - Study eye - Day 28±4 | -15.6 mm | Standard Deviation 24.5 |
| Sodium Hyaluronate PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Itching - Non Study eye - Day 14±2 | -8.9 mm | Standard Deviation 12.6 |
| Sodium Hyaluronate PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Itching - Non study eye - Day 31-41 | -15.7 mm | Standard Deviation 21.4 |
| Sodium Hyaluronate PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Pain - Study eye - Day 14±2 | -14.2 mm | Standard Deviation 17.3 |
| Sodium Hyaluronate PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Blurred vision - Non Study eye - Day 28±4 | -8.8 mm | Standard Deviation 19 |
| Sodium Hyaluronate PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Pain - Non Study eye - Day 14±2 | -10.7 mm | Standard Deviation 11 |
| Sodium Hyaluronate PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Photophobia - Non study eye - Day 31-41 | -19.9 mm | Standard Deviation 26.6 |
| Sodium Hyaluronate PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Sticky feeling- Study eye - Day 14±2 | -5.6 mm | Standard Deviation 15 |
| Sodium Hyaluronate PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Photophobia - Study eye - Day 28±4 | -26.1 mm | Standard Deviation 23.4 |
| Sodium Hyaluronate PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Sticky feeling- Non Study eye - Day 14±2 | -5.7 mm | Standard Deviation 12.2 |
| Sodium Hyaluronate PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Pain - Study eye - Day 31-41 | -20.7 mm | Standard Deviation 18 |
| Sodium Hyaluronate PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Blurred vision- Study eye - Day 14±2 | -12.0 mm | Standard Deviation 15.3 |
| Sodium Hyaluronate PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Photophobia - Non Study eye - Day 28±4 | -23.3 mm | Standard Deviation 26.2 |
| Sodium Hyaluronate PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Blurred vision- Non Study eye - Day 14±2 | -5.7 mm | Standard Deviation 12 |
| Sodium Hyaluronate PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Blurred vision - Non study eye - Day 31-41 | -9.8 mm | Standard Deviation 18.7 |
| Sodium Hyaluronate PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Photophobia - Study eye - Day 14±2 | -18.5 mm | Standard Deviation 17.5 |
| Sodium Hyaluronate PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Total score - Study eye - Day 28±4 | -143.1 mm | Standard Deviation 107.5 |
| Sodium Hyaluronate PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Photophobia - Non Study eye - Day 14±2 | -19.5 mm | Standard Deviation 20.9 |
| Sodium Hyaluronate PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Pain - Non study eye - Day 31-41 | -18.6 mm | Standard Deviation 19.4 |
| Sodium Hyaluronate PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Total score - Study eye - Day 14±2 | -93.2 mm | Standard Deviation 74.3 |
| Sodium Hyaluronate PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Total score - Non Study eye - Day 28±4 | -105.0 mm | Standard Deviation 75.9 |
| Sodium Hyaluronate PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Total score - Non Study eye - Day 14±2 | -70.9 mm | Standard Deviation 56.3 |
| Sodium Hyaluronate PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Total score - Non study eye - Day 31-41 | -101.4 mm | Standard Deviation 95.8 |
| Sodium Hyaluronate PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Foreign Body sensation - Study eye -Day 28±4 | -26.7 mm | Standard Deviation 19.8 |
| Sodium Hyaluronate PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Foreign Body sensation - Study eye - Day 31-41 | -28.1 mm | Standard Deviation 18.2 |
| Sodium Hyaluronate PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Foreign Body sensation - Non Study eye -Day 28±4 | -21.8 mm | Standard Deviation 12.1 |
| Sodium Hyaluronate PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Sticky feeling - Study eye - Day 31-41 | -13.3 mm | Standard Deviation 19.4 |
| Sodium Hyaluronate PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Burning /Stinging - Study eye - Day 28±4 | -23.0 mm | Standard Deviation 20 |
| Sodium Hyaluronate PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Foreign Body sensation - Non study eye - Day 31-41 | -18.4 mm | Standard Deviation 14.2 |
| Sodium Hyaluronate PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Burning /Stinging - Non Study eye - Day 28±4 | -12.3 mm | Standard Deviation 15.6 |
| Sodium Hyaluronate PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Photophobia - Study eye - Day 31-41 | -24.9 mm | Standard Deviation 26 |
| Sodium Hyaluronate PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Itching - Study eye - Day 28±4 | -18.5 mm | Standard Deviation 17.3 |
| Sodium Hyaluronate PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Burning/Stinging -Study eye -Day 31-41 | -23.6 mm | Standard Deviation 20.2 |
| Sodium Hyaluronate PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Itching - Non Study eye - Day 28±4 | -15.1 mm | Standard Deviation 16.2 |
| Sodium Hyaluronate PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Sticky feeling - Non study eye - Day 31-41 | -5.2 mm | Standard Deviation 16.3 |
| Sodium Hyaluronate PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Pain - Study eye - Day 28±4 | -20.1 mm | Standard Deviation 18.4 |
| Sodium Hyaluronate PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Burning/Stinging - Non study eye - Day 31-41 | -14.1 mm | Standard Deviation 18.6 |
| Sodium Hyaluronate PP | Changes From Baseline (Visit 2, Day 1) in Ocular Tolerability Using a Visual Analogue Scale (VAS) | Pain - Non Study eye - Day 28±4 | -14.5 mm | Standard Deviation 15.3 |
Comparison: Foreign Body Sensation in the Study Eye was analyzed using a repeated measures ANOVA, which evaluates changes from baseline across all time points in a single analysis. This method provides one overall value for comparison, as it incorporates all time points into a unified analysis. Consequently, the reported value represents the global outcome across time points, consistent with the repeated measures ANOVA methodology.p-value: 0.822695% CI: [-7.66, 6.11]ANOVA
Comparison: Burning/Stinging in Study eye was analyzed using a repeated measures ANOVA, which evaluates changes from baseline across all time points in a single analysis. This method provides one overall value for comparison, as it incorporates all time points into a unified analysis. Consequently, the reported value represents the global outcome across time points, consistent with the repeated measures ANOVA methodology.p-value: 0.317895% CI: [-3.13, 9.44]ANOVA
Comparison: Itching in Study eye was analyzed using a repeated measures ANOVA, which evaluates changes from baseline across all time points in a single analysis. This method provides one overall value for comparison, as it incorporates all time points into a unified analysis. Consequently, the reported value represents the global outcome across time points, consistent with the repeated measures ANOVA methodology.p-value: 0.008595% CI: [1.74, 11.3]ANOVA
Comparison: Pain in Study eye was analyzed using a repeated measures ANOVA, which evaluates changes from baseline across all time points in a single analysis. This method provides one overall value for comparison, as it incorporates all time points into a unified analysis. Consequently, the reported value represents the global outcome across time points, consistent with the repeated measures ANOVA methodology.p-value: 0.312495% CI: [-3.31, 10.13]ANOVA
Comparison: Sticky feeling in Study eye was analyzed using a repeated measures ANOVA, which evaluates changes from baseline across all time points in a single analysis. This method provides one overall value for comparison, as it incorporates all time points into a unified analysis. Consequently, the reported value represents the global outcome across time points, consistent with the repeated measures ANOVA methodology.p-value: 0.037795% CI: [0.4, 13.12]ANOVA
Comparison: Blurred vision in Study eye was analyzed using a repeated measures ANOVA, which evaluates changes from baseline across all time points in a single analysis. This method provides one overall value for comparison, as it incorporates all time points into a unified analysis. Consequently, the reported value represents the global outcome across time points, consistent with the repeated measures ANOVA methodology.p-value: 0.532195% CI: [-4.62, 8.83]ANOVA
Comparison: Photophobia in Study eye was analyzed using a repeated measures ANOVA, which evaluates changes from baseline across all time points in a single analysis. This method provides one overall value for comparison, as it incorporates all time points into a unified analysis. Consequently, the reported value represents the global outcome across time points, consistent with the repeated measures ANOVA methodology.p-value: 0.57995% CI: [-6.04, 10.68]ANOVA
Comparison: Total ocular tolerability score in Study eye was analyzed using a repeated measures ANOVA, which evaluates changes from baseline across all time points in a single analysis. This method provides one overall value for comparison, as it incorporates all time points into a unified analysis. Consequently, the reported value represents the global outcome across time points, consistent with the repeated measures ANOVA methodology.p-value: 0.338395% CI: [-17.41, 49.68]ANOVA
Secondary
Treatment-emergent Adverse Events (TEAEs), Including Adverse Device Effects (ADEs)
Occurrence of Treatment-emergent adverse events (TEAEs), including adverse device effects (ADEs) assessed throughout the study after the first IMD administration.
Time frame: From Visit 2 (Day 1) i.e., the day of the first IMD administration to Visit 5 - Final visit/Follow up - Day 31- 41
Population: The Safety Population (SAF) included all subjects who received at least one dose of the IMDs (Lubricin or Sodium Hyaluronate-OcuYal®).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lubricin PP | Treatment-emergent Adverse Events (TEAEs), Including Adverse Device Effects (ADEs) | TEAEs - Related to Treatment | 4 Number of adverse events |
| Lubricin PP | Treatment-emergent Adverse Events (TEAEs), Including Adverse Device Effects (ADEs) | TEAEs - Moderate | 4 Number of adverse events |
| Lubricin PP | Treatment-emergent Adverse Events (TEAEs), Including Adverse Device Effects (ADEs) | TEAEs - Unknown | 0 Number of adverse events |
| Lubricin PP | Treatment-emergent Adverse Events (TEAEs), Including Adverse Device Effects (ADEs) | TEAEs - Severe | 0 Number of adverse events |
| Lubricin PP | Treatment-emergent Adverse Events (TEAEs), Including Adverse Device Effects (ADEs) | TEAEs - Not Related to Treatment | 0 Number of adverse events |
| Lubricin PP | Treatment-emergent Adverse Events (TEAEs), Including Adverse Device Effects (ADEs) | All serious TEAEs | 0 Number of adverse events |
| Lubricin PP | Treatment-emergent Adverse Events (TEAEs), Including Adverse Device Effects (ADEs) | TEAEs - Mild | 0 Number of adverse events |
| Lubricin PP | Treatment-emergent Adverse Events (TEAEs), Including Adverse Device Effects (ADEs) | TEAEs - Leading to discontinuation | 4 Number of adverse events |
| Lubricin PP | Treatment-emergent Adverse Events (TEAEs), Including Adverse Device Effects (ADEs) | All TEAEs | 4 Number of adverse events |
| Sodium Hyaluronate PP | Treatment-emergent Adverse Events (TEAEs), Including Adverse Device Effects (ADEs) | TEAEs - Leading to discontinuation | 0 Number of adverse events |
| Sodium Hyaluronate PP | Treatment-emergent Adverse Events (TEAEs), Including Adverse Device Effects (ADEs) | All TEAEs | 6 Number of adverse events |
| Sodium Hyaluronate PP | Treatment-emergent Adverse Events (TEAEs), Including Adverse Device Effects (ADEs) | TEAEs - Related to Treatment | 0 Number of adverse events |
| Sodium Hyaluronate PP | Treatment-emergent Adverse Events (TEAEs), Including Adverse Device Effects (ADEs) | TEAEs - Not Related to Treatment | 6 Number of adverse events |
| Sodium Hyaluronate PP | Treatment-emergent Adverse Events (TEAEs), Including Adverse Device Effects (ADEs) | TEAEs - Unknown | 5 Number of adverse events |
| Sodium Hyaluronate PP | Treatment-emergent Adverse Events (TEAEs), Including Adverse Device Effects (ADEs) | TEAEs - Mild | 0 Number of adverse events |
| Sodium Hyaluronate PP | Treatment-emergent Adverse Events (TEAEs), Including Adverse Device Effects (ADEs) | TEAEs - Moderate | 1 Number of adverse events |
| Sodium Hyaluronate PP | Treatment-emergent Adverse Events (TEAEs), Including Adverse Device Effects (ADEs) | TEAEs - Severe | 0 Number of adverse events |
| Sodium Hyaluronate PP | Treatment-emergent Adverse Events (TEAEs), Including Adverse Device Effects (ADEs) | All serious TEAEs | 0 Number of adverse events |