Skip to main content
OpenTrials
Completed

NCT Number: NCT03660878

A Methodology Development Environmental Clinical Trial of Reproxalap in Subjects With Seasonal Allergic Conjunctivitis

A Multi-Center, Double-Masked, Randomized, Parallel-Group, Vehicle-Controlled, Methodology Development Environmental Clinical Trial with Reproxalap Ophthalmic Solutions (0.25% and 0.5%) in Subjects with Seasonal Allergic Conjunctivitis.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Slade & Baker Vision

Houston, Texas, 77027, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 ragweed pollen as confirmed by the allergic skin test given to the subject within 24 months of the subject's Visit 1
  • 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 any of the investigational product medication or 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 months prior to Visit 1, or during the trial, or a history of refractive surgery six months prior to Visit 1, or have systemic surgery planned during the clinical trial or within 30 days after;
  • have a known history of retinal detachment, diabetic retinopathy, or active retinal disease
  • have an active ocular infection (bacterial, viral or fungal), active uveitis, or positive history of an ocular herpetic infection at any visit;
  • be a female who is currently pregnant, planning a pregnancy, or lactating

Treatment and study plan

Reproxalap ophthalmic solution (0.25%)

Drug

Reproxalap Ophthalmic Solution (0.25%) administered four times a day and an additional four times a day on an as needed basis.

Reproxalap Ophthalmic Solution (0.5%)

Drug

Reproxalap Ophthalmic Solution (0.5%) administered four times a day and an additional four times a day on an as needed basis.

Vehicle Ophthalmic Solution

Drug

Vehicle Ophthalmic Solution administered four times a day and an additional four times a day on an as needed basis.

Primary outcomes

  1. Change From Baseline Ocular Itching Score on High Pollen Days

    Time frame: Efficacy was assessed on high-pollen days over 28 days of treatment; baseline was assessed approximately one week before dosing.

    Mean change from baseline in ocular itching score using a 0 to 4 scale (0 = least, 4 = most) was assessed on days when peak pollen counts meet or exceed the American Academy of Allergy Asthma & Immunology weed pollen scale 95th percentile (325 grains per cubic meter). The least squares mean (standard error) was derived from analysis of covariance with baseline, treatment, and day as factors.

Sponsors and collaborators

Lead sponsor

Aldeyra Therapeutics, Inc.

Industry

Registry information

Official study title

A Multi-Center, Double-Masked, Randomized, Parallel-Group, Vehicle-Controlled, Methodology Development Environmental Clinical Trial With Reproxalap Ophthalmic Solutions (0.25% and 0.5%) in Subjects With Seasonal Allergic Conjunctivitis

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 7, 2018
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.