Phase 2
N=70
A Methodology Development Clinical Trial of Reproxalap in Subjects With Seasonal Allergic Conjunctivitis Using the Environmental Exposure Chamber
Conjunctivitis, Allergic
Bottom Line
View on ClinicalTrials.gov: NCT03709121 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Subject-Reported Ocular Itching Score — 16.410; 16.964; 22.310 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- 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
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subject-Reported Ocular Itching Score |
16.410; 16.964; 22.310 | — |
| SECONDARY Subject-Reported Ocular Tearing Score |
0.8777; 0.8915; 1.0507 | — |
| SECONDARY Investigator-Assessed Conjunctival Redness Score |
0.5004; 0.5462; 0.6497 | — |
Summary
An Exploratory Clinical Trial Evaluating Reproxalap Ophthalmic Solutions (0.25% and 0.5%) in Subjects with Seasonal Allergic Conjunctivitis Using the Environmental Exposure Chamber (EEC)
Eligibility Criteria
Inclusion Criteria
- be at least 18 years of age of either gender and any race
- have at least a two-year history of moderate-to-severe ragweed-induced allergic conjunctivitis based on principal investigator's judgement
- have a positive skin prick test to ragweed pollen within the past year of screening
Exclusion Criteria
- known contraindication or hypersensitivities to any components of the investigational product medication or components
- history of uveitis, blepharitis, dry eye syndrome, herpes simplex keratitis, or herpes zoster keratitis;
- presence of any ocular infection (bacterial, viral, or fungal) or active ocular inflammation (e.g., follicular conjunctivitis, allergic conjunctivitis) within 14 days prior to screening
- presence of any chronic ocular degenerative condition or ocular inflammation that, in the opinion of the investigator, is likely to worsen over the course of the clinical trial;
- presence of any chronic ocular degenerative condition or ocular inflammation that, in the opinion of the investigator, is likely to worsen over the course of the clinical trial
- diagnosis of moderate-to-severe pinguecula or pterygium (particularly if it results in chronic erythema), Stevens-Johnson Syndrome, ocular cicatricial pemphigoid, mucous membrane pemphigoid, significant conjunctival scarring, chemical burn, herpetic or neurotrophic keratitis, Cryopyrin Associated Periodic Syndrome (CAPS), or keratoconus
- woman of childbearing potential who is pregnant or nursing
Data sourced from ClinicalTrials.gov (NCT03709121). 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.