Dry Eye Syndromes
Conditions
Brief summary
This study will evaluate the safety, tolerability and efficacy of IC265 compared to vehicle in participants with signs and symptoms dry eye disease.
Interventions
DRUGIC265 Ophthalmic Solution 1%
1 drop will be instilled in each eye twice a day
1 drop will be instilled in each eye twice a day
Sponsors
Iacta Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Be at least 18 years of age; * Provide written informed consent * Have a reported or documented history of dry eye for at least 6 months prior to Visit 1 * Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1 * Report a score of ≥ 2 on a Ocular Discomfort & 4-symptom questionnaire in at least one symptom at Visits 1 and 2 * Have a Schirmer's Test score of ≤10mm and ≥1mm in at least one eye at Visits 1and 2 * Have a pre-CAE(controlled adverse environment) (conjunctival redness score ≥ 1 according to the Conjunctival Redness for Dry Eye Scale in at least one eye at Visits 1 and 2 * Have a corneal fluorescein staining score of ≥ 2 in at least one region (e.g. inferior, superior, or central) at Visits 1 and 2 * Have a sum corneal fluorescein staining score of ≥ 4, based on the sum of the inferior, superior, and central regions at Visits 1 and 2 * Have a total lissamine green conjunctival score of ≥ 2, based on the sum of the temporal and nasal regions at Visits 1 and 2 * Demonstrate a response to the CAE at Visits 1 and 2 as defined by: 1. Having at least a ≥1 point increase in fluorescein staining in the inferior region in at least one eye following CAE exposure 2. Reporting an Ocular Discomfort Score ≥3 at 2 or more consecutive time points in at least one eye during CAE exposure (if a subject has an ocular discomfort rating of 3 at time = 0 for an eye, s/he must report an ocular discomfort rating of 4 for two consecutive measurements for that eye) Note: a subject cannot have an ocular discomfort score of 4 at time = 0)
Exclusion criteria
* Have any clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction, ocular rosacea, lid margin inflammation or active ocular allergies that require therapeutic treatment * Have any clinically significant (CS) posterior chamber findings, or a history of such findings/disorders, that may include exudative (i.e., wet) age-related macular degeneration, retinal vein occlusion, diabetic retinopathy, glaucoma, ocular hypertension, or any other retinal or optic nerve disease/disorder that require therapeutic treatment and/or in the opinion of the Investigator may interfere with study parameters * Have worn contact lenses within 48 hours prior to Visit 1 or anticipate using contact lenses during the study * Have laser-assisted in situ keratomileusis (LASIK) or similar type of corneal refractive surgery and/or any other ocular surgical procedure within 12 months prior to Visit 1; or have any ocular surgical procedure scheduled to be conducted during the study period * Have had any surgeries of the ocular surface or lid in the past 6 months * Have a history of lacrimal duct obstruction in either eye within 12 months prior to Visit 1 * Have used temporary (i.e., collagen) punctal plugs within 12 weeks prior to Visit 1 or anticipate their use during the study period * Have permanent punctal plugs inserted or removed - including falling out - or have had surgical punctal occlusion within 12 weeks prior to Visit 1 or anticipate any such event at any time during the study period * Use any of the following treatments in the period indicated before Visit 1 or anticipate their use at any time during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Discomfort and Dry Eye Symptoms | Change from Baseline Post-CAE® (controlled adverse environment) Day 15 | Subjects will rate the severity of each of the following symptoms, with regard to how both their eyes feel, in general - overall ocular discomfort, burning, dryness, grittiness and stinging according to the following 6-point (0 to 5) scale where 0 = none and 5 = worst. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Tear Film Break-up Time (TFBUT) | Change from Baseline Pre-CAE® (controlled adverse environment) in TFBUT in Study Eye Day 15 | With the aid of a slit-lamp, the examiner will monitor the integrity of the tear film, noting the time it takes to form micelles from the time that the eye is opened. TFBUT will be measured in seconds using a stopwatch and a digital image recording system for the right eye followed by the left eye. For each eye, 2 measurements will be taken and averaged unless the 2 measurements are \> 2 seconds apart and are each \< 10 seconds, in which case, a third measurement would be taken and the 2 closest of the 3 would be averaged. |
| Ocular Surface Disease Index (OSDI)© | Day 15 | Change from baseline to Visit 3 (Day 15). Subjects will complete the OSDI© questionnaire. The OSDI© is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease. the OSDI© is a valid and reliable instrument for measure dry eye disease (normal, mild to moderate, and severe) and effects vision-related function. |
| Schirmer's Test | Day 15 | Change from Baseline. Schirmer Tear Test will be performed according to the following procedure: * Using a sterile Tear Flo Schirmer test strip, a bend in the strip will be made in line with the notch in the strip. * The subject will be instructed to gaze up and in. * The Schirmer test strip will be placed in the lower temporal lid margin of each eye such that the strip fits tightly. Subjects will be instructed to close their eyes. * After 5 minutes have elapsed, the Schirmer strip will be removed. The length of the moistened area will be recorded (mm) for each eye. |
| Ocular Discomfort During CAE - Change From Baseline to Visit 3 | Day 15 | Change from Baseline in Ora to Visit 3 Calibra® Ocular Discomfort Scale During the CAE® in the Study Eye. Ocular discomfort scores will be subjectively graded by the subjects according to the following scale: 0 - no discomfort, 1 - intermittent awareness, 2 - constant awareness, 3 - intermittent discomfort, 4 - constant discomfort. |
| Daily Diary Symptom Score | Daily Diary Evening - Day 8 to Day 14 | Subject Daily Diary in the Evening - Day 8 to Day 14 average, Subjects will rate the severity of each of the following symptoms, with regard to how both their eyes feel, in general - overall ocular discomfort, burning, dryness, grittiness and stinging according to the following 6-point (0 to 5) scale where 0 = none and 5 = worst.The average of the daily diary scores will be summarized using continuous descriptive statistics for the time period. |
| Conjunctival Redness | Change from Baseline to Day 15 | Conjunctival Redness 5 point scale (0 - Normal, without vasodilation, 1 - Trace ciliary or conjunctival vasodilation, 2 - Broad ciliary vasodilation, 3 - Broad ciliary and slight, horizontal conjunctival vasodilation, 4 - Broad ciliary and prominent, horizontal conjunctival vasodilation) |
| Lissamine Green Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score | Day 15 | Change from Baseline Pre-CAE® in Corneal Lissamine Green Staining in Study Eye. The staining will be graded with a Corneal and Conjunctival Staining Scale. The scale is a 5 point scale from 0 (no staining) to 4 (confluent). |
| Fluorescein Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score | Day 15 | Change from Baseline Pre-CAE® to Post-CAE® in Corneal Fluorescein Staining in the Study Eye. The staining will be graded with a Corneal and Conjunctival Staining Scale. The scale is a 5 point scale from 0 (no staining) to 4 (confluent). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IC265 Ophthalmic Solution 1% 1 drop will be instilled in each eye twice daily.
IC265 Ophthalmic Solution 1%: 1 drop will be instilled in each eye twice a day | 20 |
| Placebo Ophthalmic Solution (Vehicle) 1 drop will be instilled in each eye twice daily.
Placebo Ophthalmic Solution (Vehicle): 1 drop will be instilled in each eye twice a day | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 6 | 0 |
| Overall Study | Sponsor Termination of Study | 14 | 20 |
Baseline characteristics
| Characteristic | Total | IC265 Ophthalmic Solution 1% | Placebo Ophthalmic Solution (Vehicle) |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 19 Participants | 10 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 10 Participants | 11 Participants |
| Age, Continuous | 67.1 years STANDARD_DEVIATION 10.06 | 68.4 years STANDARD_DEVIATION 8.48 | 65.8 years STANDARD_DEVIATION 11.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 40 Participants | 20 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 24 Participants | 11 Participants | 13 Participants |
| Sex: Female, Male Male | 16 Participants | 9 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 20 / 20 | 5 / 20 |
| serious Total, serious adverse events | 1 / 20 | 0 / 20 |
Outcome results
Primary
Ocular Discomfort and Dry Eye Symptoms
Subjects will rate the severity of each of the following symptoms, with regard to how both their eyes feel, in general - overall ocular discomfort, burning, dryness, grittiness and stinging according to the following 6-point (0 to 5) scale where 0 = none and 5 = worst.
Time frame: Change from Baseline Post-CAE® (controlled adverse environment) Day 15
Population: Intent to Treat - only 14 participants in the IC265 Ophthalmic Solution 1% and 19 in the Placebo Ophthalmic Solution reached Day 15.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IC265 Ophthalmic Solution 1% | Ocular Discomfort and Dry Eye Symptoms | Burning | -0.5 score on a scale | Standard Deviation 1.34 |
| IC265 Ophthalmic Solution 1% | Ocular Discomfort and Dry Eye Symptoms | Dryness | -0.7 score on a scale | Standard Deviation 1.27 |
| IC265 Ophthalmic Solution 1% | Ocular Discomfort and Dry Eye Symptoms | Grittiness | -0.4 score on a scale | Standard Deviation 1.22 |
| IC265 Ophthalmic Solution 1% | Ocular Discomfort and Dry Eye Symptoms | Stinging | -0.8 score on a scale | Standard Deviation 1.63 |
| IC265 Ophthalmic Solution 1% | Ocular Discomfort and Dry Eye Symptoms | Overall Ocular Discomfort | -0.6 score on a scale | Standard Deviation 1.09 |
| Placebo Ophthalmic Solution (Vehicle) | Ocular Discomfort and Dry Eye Symptoms | Stinging | -0.1 score on a scale | Standard Deviation 1.15 |
| Placebo Ophthalmic Solution (Vehicle) | Ocular Discomfort and Dry Eye Symptoms | Overall Ocular Discomfort | 0.3 score on a scale | Standard Deviation 0.82 |
| Placebo Ophthalmic Solution (Vehicle) | Ocular Discomfort and Dry Eye Symptoms | Burning | -0.7 score on a scale | Standard Deviation 1.38 |
| Placebo Ophthalmic Solution (Vehicle) | Ocular Discomfort and Dry Eye Symptoms | Grittiness | 0.2 score on a scale | Standard Deviation 1.38 |
| Placebo Ophthalmic Solution (Vehicle) | Ocular Discomfort and Dry Eye Symptoms | Dryness | 0.3 score on a scale | Standard Deviation 0.56 |
Other Pre-specified
Conjunctival Redness
Conjunctival Redness 5 point scale (0 - Normal, without vasodilation, 1 - Trace ciliary or conjunctival vasodilation, 2 - Broad ciliary vasodilation, 3 - Broad ciliary and slight, horizontal conjunctival vasodilation, 4 - Broad ciliary and prominent, horizontal conjunctival vasodilation)
Time frame: Change from Baseline to Day 15
Population: Intent to Treat - Only 14 participants in the IC265 Ophthalmic Solution 1% and 19 in the Placebo Ophthalmic Solution provided daily diaries in this timeframe.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IC265 Ophthalmic Solution 1% | Conjunctival Redness | -0.3 score on a scale | Standard Deviation 15.45 |
| Placebo Ophthalmic Solution (Vehicle) | Conjunctival Redness | -0.15 score on a scale | Standard Deviation 12.12 |
Other Pre-specified
Daily Diary Symptom Score
Subject Daily Diary in the Evening - Day 8 to Day 14 average, Subjects will rate the severity of each of the following symptoms, with regard to how both their eyes feel, in general - overall ocular discomfort, burning, dryness, grittiness and stinging according to the following 6-point (0 to 5) scale where 0 = none and 5 = worst.The average of the daily diary scores will be summarized using continuous descriptive statistics for the time period.
Time frame: Daily Diary Evening - Day 8 to Day 14
Population: Intent to Treat - Only 14 participants in the IC265 Ophthalmic Solution 1% and 19 in the Placebo Ophthalmic Solution provided daily diaries in this timeframe.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IC265 Ophthalmic Solution 1% | Daily Diary Symptom Score | Burning | 1.3 score on a scale | Standard Deviation 1.2 |
| IC265 Ophthalmic Solution 1% | Daily Diary Symptom Score | Grittiness | 2.1 score on a scale | Standard Deviation 1.45 |
| IC265 Ophthalmic Solution 1% | Daily Diary Symptom Score | Dryness | 2.7 score on a scale | Standard Deviation 1.21 |
| IC265 Ophthalmic Solution 1% | Daily Diary Symptom Score | Stinging | 1.3 score on a scale | Standard Deviation 1.25 |
| IC265 Ophthalmic Solution 1% | Daily Diary Symptom Score | Ocular Discomfort | 2.6 score on a scale | Standard Deviation 1.3 |
| Placebo Ophthalmic Solution (Vehicle) | Daily Diary Symptom Score | Stinging | 1.3 score on a scale | Standard Deviation 1.38 |
| Placebo Ophthalmic Solution (Vehicle) | Daily Diary Symptom Score | Ocular Discomfort | 2.2 score on a scale | Standard Deviation 1.06 |
| Placebo Ophthalmic Solution (Vehicle) | Daily Diary Symptom Score | Burning | 1.5 score on a scale | Standard Deviation 1.28 |
| Placebo Ophthalmic Solution (Vehicle) | Daily Diary Symptom Score | Dryness | 2.6 score on a scale | Standard Deviation 0.99 |
| Placebo Ophthalmic Solution (Vehicle) | Daily Diary Symptom Score | Grittiness | 1.2 score on a scale | Standard Deviation 1.24 |
Other Pre-specified
Fluorescein Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score
Change from Baseline Pre-CAE® to Post-CAE® in Corneal Fluorescein Staining in the Study Eye. The staining will be graded with a Corneal and Conjunctival Staining Scale. The scale is a 5 point scale from 0 (no staining) to 4 (confluent).
Time frame: Day 15
Population: Intent-to-Treat Population - Only 14 participants in the IC265 Ophthalmic Solution 1% and 19 in the Placebo Ophthalmic Solution provided daily diaries in this timeframe.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IC265 Ophthalmic Solution 1% | Fluorescein Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score | Inferior | -0.32 score on a scale | Standard Deviation 0.75 |
| IC265 Ophthalmic Solution 1% | Fluorescein Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score | Superior | -0.21 score on a scale | Standard Deviation 0.752 |
| IC265 Ophthalmic Solution 1% | Fluorescein Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score | Central | -0.04 score on a scale | Standard Deviation 1.308 |
| IC265 Ophthalmic Solution 1% | Fluorescein Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score | Temporal | 0.07 score on a scale | Standard Deviation 0.675 |
| IC265 Ophthalmic Solution 1% | Fluorescein Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score | Nasal | 0.11 score on a scale | Standard Deviation 0.836 |
| IC265 Ophthalmic Solution 1% | Fluorescein Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score | Corneal Sum | -0.57 score on a scale | Standard Deviation 2.165 |
| IC265 Ophthalmic Solution 1% | Fluorescein Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score | Conjunctival Sum | 0.18 score on a scale | Standard Deviation 0.868 |
| IC265 Ophthalmic Solution 1% | Fluorescein Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score | Total Sum | -0.39 score on a scale | Standard Deviation 2.558 |
| Placebo Ophthalmic Solution (Vehicle) | Fluorescein Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score | Total Sum | 0.26 score on a scale | Standard Deviation 3.048 |
| Placebo Ophthalmic Solution (Vehicle) | Fluorescein Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score | Inferior | -0.55 score on a scale | Standard Deviation 0.832 |
| Placebo Ophthalmic Solution (Vehicle) | Fluorescein Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score | Nasal | -0.08 score on a scale | Standard Deviation 0.886 |
| Placebo Ophthalmic Solution (Vehicle) | Fluorescein Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score | Superior | 0.26 score on a scale | Standard Deviation 1.046 |
| Placebo Ophthalmic Solution (Vehicle) | Fluorescein Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score | Conjunctival Sum | 0.32 score on a scale | Standard Deviation 1.406 |
| Placebo Ophthalmic Solution (Vehicle) | Fluorescein Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score | Central | 0.24 score on a scale | Standard Deviation 1.147 |
| Placebo Ophthalmic Solution (Vehicle) | Fluorescein Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score | Corneal Sum | -0.05 score on a scale | Standard Deviation 2.598 |
| Placebo Ophthalmic Solution (Vehicle) | Fluorescein Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score | Temporal | 0.39 score on a scale | Standard Deviation 0.809 |
Other Pre-specified
Lissamine Green Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score
Change from Baseline Pre-CAE® in Corneal Lissamine Green Staining in Study Eye. The staining will be graded with a Corneal and Conjunctival Staining Scale. The scale is a 5 point scale from 0 (no staining) to 4 (confluent).
Time frame: Day 15
Population: Intent-to-Treat Population - Only 14 participants in the IC265 Ophthalmic Solution 1% and 19 in the Placebo Ophthalmic Solution provided daily diaries in this timeframe.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IC265 Ophthalmic Solution 1% | Lissamine Green Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score | Inferior | 0.50 score on a scale | Standard Deviation 0.92 |
| IC265 Ophthalmic Solution 1% | Lissamine Green Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score | Superior | 0.43 score on a scale | Standard Deviation 1.107 |
| IC265 Ophthalmic Solution 1% | Lissamine Green Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score | Central | 0.43 score on a scale | Standard Deviation 0.756 |
| IC265 Ophthalmic Solution 1% | Lissamine Green Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score | Temporal | -0.07 score on a scale | Standard Deviation 0.616 |
| IC265 Ophthalmic Solution 1% | Lissamine Green Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score | Nasal | 0.07 score on a scale | Standard Deviation 0.584 |
| IC265 Ophthalmic Solution 1% | Lissamine Green Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score | Corneal Sum | 1.36 score on a scale | Standard Deviation 2.089 |
| IC265 Ophthalmic Solution 1% | Lissamine Green Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score | Conjunctival Sum | 0.00 score on a scale | Standard Deviation 0.941 |
| IC265 Ophthalmic Solution 1% | Lissamine Green Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score | Total Sum | 1.36 score on a scale | Standard Deviation 2.825 |
| Placebo Ophthalmic Solution (Vehicle) | Lissamine Green Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score | Total Sum | 1.24 score on a scale | Standard Deviation 2.791 |
| Placebo Ophthalmic Solution (Vehicle) | Lissamine Green Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score | Inferior | 0.32 score on a scale | Standard Deviation 1.017 |
| Placebo Ophthalmic Solution (Vehicle) | Lissamine Green Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score | Nasal | 0.11 score on a scale | Standard Deviation 0.658 |
| Placebo Ophthalmic Solution (Vehicle) | Lissamine Green Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score | Superior | 0.55 score on a scale | Standard Deviation 0.985 |
| Placebo Ophthalmic Solution (Vehicle) | Lissamine Green Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score | Conjunctival Sum | 0.05 score on a scale | Standard Deviation 1.177 |
| Placebo Ophthalmic Solution (Vehicle) | Lissamine Green Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score | Central | 0.32 score on a scale | Standard Deviation 0.582 |
| Placebo Ophthalmic Solution (Vehicle) | Lissamine Green Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score | Corneal Sum | 1.18 score on a scale | Standard Deviation 2.129 |
| Placebo Ophthalmic Solution (Vehicle) | Lissamine Green Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score | Temporal | -0.05 score on a scale | Standard Deviation 0.864 |
Other Pre-specified
Ocular Discomfort During CAE - Change From Baseline to Visit 3
Change from Baseline in Ora to Visit 3 Calibra® Ocular Discomfort Scale During the CAE® in the Study Eye. Ocular discomfort scores will be subjectively graded by the subjects according to the following scale: 0 - no discomfort, 1 - intermittent awareness, 2 - constant awareness, 3 - intermittent discomfort, 4 - constant discomfort.
Time frame: Day 15
Population: Intent to Treat - Only 14 participants in the IC265 Ophthalmic Solution 1% and 19 in the Placebo Ophthalmic Solution reached Day 15.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IC265 Ophthalmic Solution 1% | Ocular Discomfort During CAE - Change From Baseline to Visit 3 | 25 Minutes | -0.1 score on a scale | Standard Deviation 0.73 |
| IC265 Ophthalmic Solution 1% | Ocular Discomfort During CAE - Change From Baseline to Visit 3 | 50 Minutes | -0.1 score on a scale | Standard Deviation 0.77 |
| IC265 Ophthalmic Solution 1% | Ocular Discomfort During CAE - Change From Baseline to Visit 3 | 15 Minutes | 0.1 score on a scale | Standard Deviation 1 |
| IC265 Ophthalmic Solution 1% | Ocular Discomfort During CAE - Change From Baseline to Visit 3 | 55 Minutes | -0.1 score on a scale | Standard Deviation 0.77 |
| IC265 Ophthalmic Solution 1% | Ocular Discomfort During CAE - Change From Baseline to Visit 3 | 30 Minutes | -0.3 score on a scale | Standard Deviation 0.73 |
| IC265 Ophthalmic Solution 1% | Ocular Discomfort During CAE - Change From Baseline to Visit 3 | 60 Minutes | 0.0 score on a scale | Standard Deviation 0.55 |
| IC265 Ophthalmic Solution 1% | Ocular Discomfort During CAE - Change From Baseline to Visit 3 | 10 Minutes | -0.1 score on a scale | Standard Deviation 0.66 |
| IC265 Ophthalmic Solution 1% | Ocular Discomfort During CAE - Change From Baseline to Visit 3 | 65 Minutes | -0.1 score on a scale | Standard Deviation 0.47 |
| IC265 Ophthalmic Solution 1% | Ocular Discomfort During CAE - Change From Baseline to Visit 3 | 35 Minutes | -0.2 score on a scale | Standard Deviation 0.8 |
| IC265 Ophthalmic Solution 1% | Ocular Discomfort During CAE - Change From Baseline to Visit 3 | 70 Minutes | 0.0 score on a scale | Standard Deviation 0.55 |
| IC265 Ophthalmic Solution 1% | Ocular Discomfort During CAE - Change From Baseline to Visit 3 | 20 Minutes | -0.1 score on a scale | Standard Deviation 0.86 |
| IC265 Ophthalmic Solution 1% | Ocular Discomfort During CAE - Change From Baseline to Visit 3 | 75 Minutes | 0.0 score on a scale | Standard Deviation 0.55 |
| IC265 Ophthalmic Solution 1% | Ocular Discomfort During CAE - Change From Baseline to Visit 3 | 40 Minutes | -0.1 score on a scale | Standard Deviation 0.77 |
| IC265 Ophthalmic Solution 1% | Ocular Discomfort During CAE - Change From Baseline to Visit 3 | 80 Minutes | 0.1 score on a scale | Standard Deviation 0.47 |
| IC265 Ophthalmic Solution 1% | Ocular Discomfort During CAE - Change From Baseline to Visit 3 | 5 Minutes | -0.1 score on a scale | Standard Deviation 0.73 |
| IC265 Ophthalmic Solution 1% | Ocular Discomfort During CAE - Change From Baseline to Visit 3 | 85 Minutes | 0.0 score on a scale | Standard Deviation 0.39 |
| IC265 Ophthalmic Solution 1% | Ocular Discomfort During CAE - Change From Baseline to Visit 3 | 45 Minutes | -0.1 score on a scale | Standard Deviation 0.77 |
| IC265 Ophthalmic Solution 1% | Ocular Discomfort During CAE - Change From Baseline to Visit 3 | 90 Minutes | 0.0 score on a scale | Standard Deviation 0.39 |
| IC265 Ophthalmic Solution 1% | Ocular Discomfort During CAE - Change From Baseline to Visit 3 | 0 Minutes | -0.4 score on a scale | Standard Deviation 0.84 |
| Placebo Ophthalmic Solution (Vehicle) | Ocular Discomfort During CAE - Change From Baseline to Visit 3 | 90 Minutes | 0.1 score on a scale | Standard Deviation 0.52 |
| Placebo Ophthalmic Solution (Vehicle) | Ocular Discomfort During CAE - Change From Baseline to Visit 3 | 0 Minutes | 0.2 score on a scale | Standard Deviation 0.6 |
| Placebo Ophthalmic Solution (Vehicle) | Ocular Discomfort During CAE - Change From Baseline to Visit 3 | 5 Minutes | -0.1 score on a scale | Standard Deviation 0.85 |
| Placebo Ophthalmic Solution (Vehicle) | Ocular Discomfort During CAE - Change From Baseline to Visit 3 | 10 Minutes | -0.2 score on a scale | Standard Deviation 0.83 |
| Placebo Ophthalmic Solution (Vehicle) | Ocular Discomfort During CAE - Change From Baseline to Visit 3 | 15 Minutes | 0.1 score on a scale | Standard Deviation 0.71 |
| Placebo Ophthalmic Solution (Vehicle) | Ocular Discomfort During CAE - Change From Baseline to Visit 3 | 20 Minutes | 0.1 score on a scale | Standard Deviation 0.62 |
| Placebo Ophthalmic Solution (Vehicle) | Ocular Discomfort During CAE - Change From Baseline to Visit 3 | 25 Minutes | 0.1 score on a scale | Standard Deviation 0.97 |
| Placebo Ophthalmic Solution (Vehicle) | Ocular Discomfort During CAE - Change From Baseline to Visit 3 | 30 Minutes | 0.0 score on a scale | Standard Deviation 0.75 |
| Placebo Ophthalmic Solution (Vehicle) | Ocular Discomfort During CAE - Change From Baseline to Visit 3 | 35 Minutes | 0.1 score on a scale | Standard Deviation 0.85 |
| Placebo Ophthalmic Solution (Vehicle) | Ocular Discomfort During CAE - Change From Baseline to Visit 3 | 40 Minutes | 0.1 score on a scale | Standard Deviation 0.66 |
| Placebo Ophthalmic Solution (Vehicle) | Ocular Discomfort During CAE - Change From Baseline to Visit 3 | 45 Minutes | 0.2 score on a scale | Standard Deviation 0.6 |
| Placebo Ophthalmic Solution (Vehicle) | Ocular Discomfort During CAE - Change From Baseline to Visit 3 | 50 Minutes | 0.2 score on a scale | Standard Deviation 0.6 |
| Placebo Ophthalmic Solution (Vehicle) | Ocular Discomfort During CAE - Change From Baseline to Visit 3 | 55 Minutes | 0.2 score on a scale | Standard Deviation 0.63 |
| Placebo Ophthalmic Solution (Vehicle) | Ocular Discomfort During CAE - Change From Baseline to Visit 3 | 60 Minutes | 0.4 score on a scale | Standard Deviation 0.68 |
| Placebo Ophthalmic Solution (Vehicle) | Ocular Discomfort During CAE - Change From Baseline to Visit 3 | 65 Minutes | 0.2 score on a scale | Standard Deviation 0.71 |
| Placebo Ophthalmic Solution (Vehicle) | Ocular Discomfort During CAE - Change From Baseline to Visit 3 | 70 Minutes | 0.1 score on a scale | Standard Deviation 0.71 |
| Placebo Ophthalmic Solution (Vehicle) | Ocular Discomfort During CAE - Change From Baseline to Visit 3 | 75 Minutes | 0.2 score on a scale | Standard Deviation 0.69 |
| Placebo Ophthalmic Solution (Vehicle) | Ocular Discomfort During CAE - Change From Baseline to Visit 3 | 80 Minutes | 0.2 score on a scale | Standard Deviation 0.96 |
| Placebo Ophthalmic Solution (Vehicle) | Ocular Discomfort During CAE - Change From Baseline to Visit 3 | 85 Minutes | 0.1 score on a scale | Standard Deviation 0.78 |
Other Pre-specified
Ocular Surface Disease Index (OSDI)©
Change from baseline to Visit 3 (Day 15). Subjects will complete the OSDI© questionnaire. The OSDI© is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease. the OSDI© is a valid and reliable instrument for measure dry eye disease (normal, mild to moderate, and severe) and effects vision-related function.
Time frame: Day 15
Population: Only 14 participants in the IC265 Ophthalmic Solution 1% and 19 in the Placebo Ophthalmic Solution reached Day 15.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IC265 Ophthalmic Solution 1% | Ocular Surface Disease Index (OSDI)© | -3.0 score on a scale | Standard Deviation 15.45 |
| Placebo Ophthalmic Solution (Vehicle) | Ocular Surface Disease Index (OSDI)© | -0.5 score on a scale | Standard Deviation 12.12 |
Other Pre-specified
Schirmer's Test
Change from Baseline. Schirmer Tear Test will be performed according to the following procedure: * Using a sterile Tear Flo Schirmer test strip, a bend in the strip will be made in line with the notch in the strip. * The subject will be instructed to gaze up and in. * The Schirmer test strip will be placed in the lower temporal lid margin of each eye such that the strip fits tightly. Subjects will be instructed to close their eyes. * After 5 minutes have elapsed, the Schirmer strip will be removed. The length of the moistened area will be recorded (mm) for each eye.
Time frame: Day 15
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IC265 Ophthalmic Solution 1% | Schirmer's Test | 0.57 mm | Standard Deviation 3.567 |
| Placebo Ophthalmic Solution (Vehicle) | Schirmer's Test | 1.95 mm | Standard Deviation 8.721 |
Other Pre-specified
Tear Film Break-up Time (TFBUT)
With the aid of a slit-lamp, the examiner will monitor the integrity of the tear film, noting the time it takes to form micelles from the time that the eye is opened. TFBUT will be measured in seconds using a stopwatch and a digital image recording system for the right eye followed by the left eye. For each eye, 2 measurements will be taken and averaged unless the 2 measurements are \> 2 seconds apart and are each \< 10 seconds, in which case, a third measurement would be taken and the 2 closest of the 3 would be averaged.
Time frame: Change from Baseline Pre-CAE® (controlled adverse environment) in TFBUT in Study Eye Day 15
Population: Change from Baseline Pre-CAE® in TFBUT in Study Eye - Intent-to-Treat Population. Only 14 participants in the IC265 Ophthalmic Solution 1% and 19 in the Placebo Ophthalmic Solution reached Day 15.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IC265 Ophthalmic Solution 1% | Tear Film Break-up Time (TFBUT) | 1.357 seconds | Standard Deviation 0.531 |
| Placebo Ophthalmic Solution (Vehicle) | Tear Film Break-up Time (TFBUT) | 0.883 seconds | Standard Deviation 0.4572 |