Dry Eye
Conditions
Brief summary
An Exploratory, Single-Center, Double-Masked, Crossover Clinical Trial to Assess Safety and Tolerability of 0.25% Reproxalap Ophthalmic Solution Compared to Xiidra® in Subjects with Dry Eye Disease in a Dry Eye Chamber
Interventions
Reproxalap Ophthalmic Solution (0.25%) dosed once
DRUGXiidra® (5% lifitegrast ophthalmic solution)
Xiidra® (5% lifitegrast ophthalmic solution) dosed once
Sponsors
Aldeyra Therapeutics, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Eighteen (18) to70 years of age at the time of screening (either gender and any race). 2. Ability to provide written informed consent. 3. Reported history of dry eye for at least 6 months prior to Visit 1.
Exclusion criteria
1. Diagnosis of an ongoing ocular infection (bacterial, viral, or fungal) or active ocular inflammation at Visit 1. 2. Contact lens use within 7 days of Visit 1 or anticipate using contact lenses during the trial. 3. A condition that the investigator feels may put the subject at significant risk may confound the study results or may interfere significantly with the subject's participation in the trial. 4. Inability or unwillingness to follow instructions, including participation in all study assessments/procedures and visits.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Ocular Discomfort | The efficacy assessment period was approximately every 5 minutes during a 45-minute dry eye chamber. Baseline was prior to dosing for each treatment period. | Ocular discomfort (0 = none, 10 = extremely severe) was reported by patients in a dry eye chamber. Change from baseline was analyzed using a mixed model repeated measures (MMRM) analysis, with baseline as a covariate, and treatment and intra-chamber time point as factors. |
| Change From Baseline in Ocular Itching | The efficacy assessment period was approximately every 5 minutes during a 45-minute dry eye chamber. Baseline was prior to dosing for each treatment period. | Ocular itching (0 = none, 10 = extremely severe) was reported by patients in a dry eye chamber. Change from baseline was analyzed using a MMRM analysis, with baseline as a covariate, and treatment and intra-chamber time point as factors. |
Countries
Canada
Participant flow
Pre-assignment details
Fifty-six subjects were enrolled in a two-period crossover design trial in which each subject received lifitegrast and reproxalp during separate treatment periods separated by approximately 7 days. Subjects were dosed once for each treatment period just before entry into a 45-minute dry eye chamber.
Participants by arm
| Arm | Count |
|---|---|
| Lifitegrast, Reproxalap Subjects received a single dose of 5% lifitegrast ophthalmic solution just before dry eye chamber entry, followed by a seven-day washout. Subjects then received a single dose of 0.25% reproxalap just before dry eye chamber entry. | 56 |
| Total | 56 |
Baseline characteristics
| Characteristic | Lifitegrast, Reproxalap |
|---|---|
| Age, Continuous | 47.9 years STANDARD_DEVIATION 12.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 47 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 12 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 33 Participants |
| Sex: Female, Male Female | 36 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 54 | 0 / 56 |
| other Total, other adverse events | 40 / 54 | 12 / 56 |
| serious Total, serious adverse events | 0 / 54 | 0 / 56 |
Outcome results
Primary
Change From Baseline in Ocular Discomfort
Ocular discomfort (0 = none, 10 = extremely severe) was reported by patients in a dry eye chamber. Change from baseline was analyzed using a mixed model repeated measures (MMRM) analysis, with baseline as a covariate, and treatment and intra-chamber time point as factors.
Time frame: The efficacy assessment period was approximately every 5 minutes during a 45-minute dry eye chamber. Baseline was prior to dosing for each treatment period.
Population: Safety population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Reproxalap | Change From Baseline in Ocular Discomfort | 1.35 score on a scale | Standard Error 0.21 |
| Lifitegrast | Change From Baseline in Ocular Discomfort | 2.07 score on a scale | Standard Error 0.25 |
Primary
Change From Baseline in Ocular Itching
Ocular itching (0 = none, 10 = extremely severe) was reported by patients in a dry eye chamber. Change from baseline was analyzed using a MMRM analysis, with baseline as a covariate, and treatment and intra-chamber time point as factors.
Time frame: The efficacy assessment period was approximately every 5 minutes during a 45-minute dry eye chamber. Baseline was prior to dosing for each treatment period.
Population: Safety population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Reproxalap | Change From Baseline in Ocular Itching | 0.93 score on a scale | Standard Error 0.21 |
| Lifitegrast | Change From Baseline in Ocular Itching | 1.54 score on a scale | Standard Error 0.25 |