Dry Eye
Conditions
Brief summary
A Multi-Center, Phase 2, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Clinical Trial to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution (0.25% Novel Formulation) Compared to Vehicle in Subjects with Dry Eye Disease
Interventions
DRUGReproxalap Ophthalmic Solution (0.25% Novel Formulation) QID to BID
Reproxalap Opthalmic Solution (0.25% Novel Formulation) administered QID for four weeks, followed by BID administration for eight weeks
DRUGVehicle Ophthalmic Solution (0.25% Novel Formulation) QID to BID
Vehicle Ophthalmic Solution administered QID for four weeks, followed by BID administration for eight weeks
Sponsors
Aldeyra Therapeutics, Inc.
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 of either gender and any race; * Have a reported 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
Exclusion criteria
* Have any clinically significant slit-lamp findings at Visit 1, including active blepharitis; meibomian gland dysfunction (MGD); lid margin inflammation; or active ocular allergies that require therapeutic treatment, or, in the opinion of the investigator may interfere with the assessment of the safety or efficacy of reproxalap or vehicle; * Have or be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal) or active ocular inflammation at Visit 1; * Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study; * Have used any eye drops within 2 hours of Visit 1; * Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months; * Have used ophthalmic cyclosporine or lifitegrast 5.0% ophthalmic solution within 90 days of Visit 1; * Have any planned ocular and/or lid surgeries over the study period or any ocular surgery within 6 months of Visit 1; * Have used temporary or permanent punctal plugs within 30 days prior to Visit 1 or anticipate their use during the study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Subject-reported Ocular Dryness Score (0 - 100 Visual Analogue Scale (VAS)) | Efficacy assessment period (Day 1 through 85) - assessed at Weeks 1, 2, 4, 6, 8, 10, and 12. Baseline was Day 1. | Change from baseline comparison of reproxalap to vehicle for subject-reported Ocular Dryness Score VAS (0 = no discomfort - 100 = maximal discomfort), where a higher score means a worse outcome. The intervention was administered bilaterally. The Least Squares Mean (standard error) was derived from mixed model repeated measures for change from baseline calculated using baseline score, treatment arm, visit, and the interaction of treatment arm and visit as fixed effects. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Reproxalap (0.25% Novel Formulation) Reproxalap ophthalmic solution administered QID for four weeks, followed by BID administration for eight weeks | 102 |
| Vehicle Vehicle ophthalmic solution administered QID for four weeks, followed by BID administration for eight weeks | 104 |
| Total | 206 |
Baseline characteristics
| Characteristic | Reproxalap (0.25% Novel Formulation) | Vehicle | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 50 Participants | 46 Participants | 96 Participants |
| Age, Categorical Between 18 and 65 years | 52 Participants | 58 Participants | 110 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 8 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 94 Participants | 96 Participants | 190 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Iris Color (Left Eye) Black | 0 Participants | 3 Participants | 3 Participants |
| Iris Color (Left Eye) Blue | 28 Participants | 27 Participants | 55 Participants |
| Iris Color (Left Eye) Brown | 46 Participants | 44 Participants | 90 Participants |
| Iris Color (Left Eye) Gray | 1 Participants | 1 Participants | 2 Participants |
| Iris Color (Left Eye) Green | 6 Participants | 9 Participants | 15 Participants |
| Iris Color (Left Eye) Hazel | 21 Participants | 20 Participants | 41 Participants |
| Iris Color (Left Eye) Other | 0 Participants | 0 Participants | 0 Participants |
| Iris Color (Right Eye) Black | 0 Participants | 3 Participants | 3 Participants |
| Iris Color (Right Eye) Blue | 28 Participants | 27 Participants | 55 Participants |
| Iris Color (Right Eye) Brown | 46 Participants | 44 Participants | 90 Participants |
| Iris Color (Right Eye) Gray | 1 Participants | 1 Participants | 2 Participants |
| Iris Color (Right Eye) Green | 6 Participants | 9 Participants | 15 Participants |
| Iris Color (Right Eye) Hazel | 21 Participants | 20 Participants | 41 Participants |
| Iris Color (Right Eye) Other | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 5 Participants | 6 Participants |
| Race/Ethnicity, Customized Black or African American | 10 Participants | 14 Participants | 24 Participants |
| Race/Ethnicity, Customized Multiple | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 89 Participants | 83 Participants | 172 Participants |
| Region of Enrollment United States | 102 participants | 104 participants | 206 participants |
| Sex: Female, Male Female | 82 Participants | 69 Participants | 151 Participants |
| Sex: Female, Male Male | 20 Participants | 35 Participants | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 102 | 0 / 104 |
| other Total, other adverse events | 91 / 102 | 8 / 104 |
| serious Total, serious adverse events | 1 / 102 | 1 / 104 |
Outcome results
Primary
Change From Baseline in Subject-reported Ocular Dryness Score (0 - 100 Visual Analogue Scale (VAS))
Change from baseline comparison of reproxalap to vehicle for subject-reported Ocular Dryness Score VAS (0 = no discomfort - 100 = maximal discomfort), where a higher score means a worse outcome. The intervention was administered bilaterally. The Least Squares Mean (standard error) was derived from mixed model repeated measures for change from baseline calculated using baseline score, treatment arm, visit, and the interaction of treatment arm and visit as fixed effects.
Time frame: Efficacy assessment period (Day 1 through 85) - assessed at Weeks 1, 2, 4, 6, 8, 10, and 12. Baseline was Day 1.
Population: Intent-to-treat Ocular Dryness Population with observed data only
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Reproxalap (0.25% Novel Formulation) | Change From Baseline in Subject-reported Ocular Dryness Score (0 - 100 Visual Analogue Scale (VAS)) | -16.0 score on a scale | Standard Error 2.2 |
| Vehicle | Change From Baseline in Subject-reported Ocular Dryness Score (0 - 100 Visual Analogue Scale (VAS)) | -9.1 score on a scale | Standard Error 2.18 |