Dry Eye Syndrome
Conditions
Keywords
reproxalap
Brief summary
A Multi-Center, Phase 2b, Randomized, Double Masked, Parallel-Group, Vehicle-Controlled, Clinical Study to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution (0.25% and 0.1%) Compared to Vehicle in Subjects with Dry Eye Disease
Interventions
Reproxalap Ophthalmic Solution (0.25%) administered for approximately twelve weeks.
DRUGReproxalap Ophthalmic Solution (0.1%)
Reproxalap Ophthalmic Solution (0.1%) administered for approximately twelve weeks.
DRUGVehicle Ophthalmic Solution
Vehicle Ophthalmic Solution administered for approximately twelve 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 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters; * 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 cyclosporine 0.05% or lifitigrast 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; * Be using or anticipate using temporary punctal plugs during the study that have not been stable within 30 days of Visit 1;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of ADX-102 on the Ora Calibra® Discomfort & 4-Symptom Questionnaire for Dryness. | Efficacy assessment period (Day 1 through Day 85) - assessed on Days 1, 15, 29, 57, and 85. | Change from baseline comparison of ADX-102 to Vehicle on the Ora Calibra® Discomfort & 4-Symptom Questionnaire (0 = least, 5 = most) for dryness across all time points. The intervention was administered bilaterally. The Least Squares Mean (Standard Error) was derived from Mixed Model Repeated Measure for change from baseline calculated using baseline score, visit, treatment, and visit-by-treatment interaction. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Reproxalap Ophthalmic Solution (0.25%) Reproxalap Ophthalmic Solution (0.25%): Reproxalap Ophthalmic Solution (0.25%) administered for approximately twelve weeks. | 100 |
| Reproxalap Ophthalmic Solution (0.1%) Reproxalap Ophthalmic Solution (0.1%): Reproxalap Ophthalmic Solution (0.1%) administered for approximately twelve weeks. | 100 |
| Vehicle Ophthalmic Solution Vehicle Ophthalmic Solution: Vehicle Ophthalmic Solution administered for approximately twelve weeks. | 100 |
| Total | 300 |
Baseline characteristics
| Characteristic | Reproxalap Ophthalmic Solution (0.25%) | Reproxalap Ophthalmic Solution (0.1%) | Vehicle Ophthalmic Solution | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 42 Participants | 50 Participants | 49 Participants | 141 Participants |
| Age, Categorical Between 18 and 65 years | 58 Participants | 50 Participants | 51 Participants | 159 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 4 Participants | 1 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 98 Participants | 96 Participants | 99 Participants | 293 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Iris Color (Left Eye) Black | 1 Participants | 1 Participants | 2 Participants | 4 Participants |
| Iris Color (Left Eye) Blue | 15 Participants | 22 Participants | 26 Participants | 63 Participants |
| Iris Color (Left Eye) Brown | 55 Participants | 47 Participants | 46 Participants | 148 Participants |
| Iris Color (Left Eye) Gray | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Iris Color (Left Eye) Green | 7 Participants | 11 Participants | 10 Participants | 28 Participants |
| Iris Color (Left Eye) Hazel | 22 Participants | 17 Participants | 16 Participants | 55 Participants |
| Iris Color (Left Eye) Other | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Iris Color (Right Eye) Black | 1 Participants | 1 Participants | 2 Participants | 4 Participants |
| Iris Color (Right Eye) Blue | 15 Participants | 22 Participants | 26 Participants | 63 Participants |
| Iris Color (Right Eye) Brown | 55 Participants | 47 Participants | 46 Participants | 148 Participants |
| Iris Color (Right Eye) Gray | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Iris Color (Right Eye) Green | 7 Participants | 11 Participants | 10 Participants | 28 Participants |
| Iris Color (Right Eye) Hazel | 22 Participants | 17 Participants | 16 Participants | 55 Participants |
| Iris Color (Right Eye) Other | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 22 Participants | 17 Participants | 17 Participants | 56 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 77 Participants | 80 Participants | 80 Participants | 237 Participants |
| Region of Enrollment United States | 100 participants | 100 participants | 100 participants | 300 participants |
| Sex: Female, Male Female | 75 Participants | 76 Participants | 28 Participants | 179 Participants |
| Sex: Female, Male Male | 25 Participants | 24 Participants | 72 Participants | 121 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 100 | 0 / 100 | 0 / 100 |
| other Total, other adverse events | 93 / 100 | 37 / 100 | 2 / 100 |
| serious Total, serious adverse events | 1 / 100 | 1 / 100 | 0 / 100 |
Outcome results
Primary
Efficacy of ADX-102 on the Ora Calibra® Discomfort & 4-Symptom Questionnaire for Dryness.
Change from baseline comparison of ADX-102 to Vehicle on the Ora Calibra® Discomfort & 4-Symptom Questionnaire (0 = least, 5 = most) for dryness across all time points. The intervention was administered bilaterally. The Least Squares Mean (Standard Error) was derived from Mixed Model Repeated Measure for change from baseline calculated using baseline score, visit, treatment, and visit-by-treatment interaction.
Time frame: Efficacy assessment period (Day 1 through Day 85) - assessed on Days 1, 15, 29, 57, and 85.
Population: Intent to treat population with observed data only.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Reproxalap (0.25%) | Efficacy of ADX-102 on the Ora Calibra® Discomfort & 4-Symptom Questionnaire for Dryness. | -0.7 units on a scale | Standard Error 0.09 |
| Reproxalap (0.1%) | Efficacy of ADX-102 on the Ora Calibra® Discomfort & 4-Symptom Questionnaire for Dryness. | -0.5 units on a scale | Standard Error 0.08 |
| Vehicle | Efficacy of ADX-102 on the Ora Calibra® Discomfort & 4-Symptom Questionnaire for Dryness. | -0.4 units on a scale | Standard Error 0.08 |