Phase 3
N=318
ALLEVIATE Trial - A Phase 3 Trial in Subjects With Allergic Conjunctivitis
Allergic Conjunctivitis
Bottom Line
View on ClinicalTrials.gov: NCT03494504 ↗Enrolled (actual)
318
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Subject-reported Ocular Itching Score — 52.003; 60.040; 74.657 units on a scale*minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Reproxalap Ophthalmic Solution (0.25%) (Drug); Reproxalap Ophthalmic Solution (0.5%) (Drug); Vehicle Ophthalmic Solution (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Aldeyra Therapeutics, Inc.
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subject-reported Ocular Itching Score |
52.003; 60.040; 74.657 | — |
| SECONDARY Number of Subjects With Two-point Reduction in Itching Score |
88; 77; 77 | — |
Summary
A Multi-Center, Double-Masked, Randomized, Parallel-Group, Vehicle-Controlled, Clinical Trial to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solutions in Subjects with Acute Allergic Conjunctivitis
Eligibility Criteria
Inclusion Criteria
- be at least 18 years of age of either gender and any race
- have a positive history of ocular allergies and a positive skin test reaction to a seasonal allergen (grasses, ragweed, and/or trees) as confirmed by an allergic skin test at the Screening Visit or within the past 24 months;
- have a calculated visual acuity of 0.7 logMAR or better in each eye as measured using an ETDRS chart
Exclusion Criteria
- have known contraindications or sensitivities to the use of the investigational product or any of its components
- have any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters (including but not limited to narrow angle glaucoma, clinically significant blepharitis, follicular conjunctivitis, iritis, pterygium or a diagnosis of dry eye)
- have had ocular surgical intervention within three (3) months prior to Visit 1 or during the trial and/or a history of refractive surgery six (6) months prior to Visit 1 or have ocular or systemic surgery planned during the study or within 30 days after
- have a known history of retinal detachment, diabetic retinopathy, or active retinal disease
- have the presence of an active ocular infection (bacterial, viral or fungal) or positive history of an ocular herpetic infection at any visit
- be a female who is currently pregnant, planning a pregnancy, lactating, not using a medically acceptable form of birth control throughout the trial duration, or has a positive urine pregnancy test at Visit 1
Data sourced from ClinicalTrials.gov (NCT03494504). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.