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Phase 3 N=318 Randomized Quadruple-blind Treatment

ALLEVIATE Trial - A Phase 3 Trial in Subjects With Allergic Conjunctivitis

Allergic Conjunctivitis

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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