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NCT03660878 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Aldeyra Therapeutics.

Completed
Registry status
Phase 1
Development phase
52
Enrollment target

NCT03660878: Completed Phase 1 study, sponsored by Aldeyra Therapeutics.

NCT03660878 is a Phase 1 study that has completed, run by Aldeyra Therapeutics. The registered enrollment target is 52 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03660878, a Phase 1 study, has completed, sponsored by Aldeyra Therapeutics.

COMPLETED
Registry status
Phase 1
Development phase
52 participants
Enrollment target

Study Summary

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.

Primary Outcome

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.

Interventions

  • DRUG Vehicle Ophthalmic Solution
  • DRUG Reproxalap Ophthalmic Solution (0.25%)
  • DRUG Reproxalap Ophthalmic Solution (0.5%)

Trial Details

FieldValue
Enrollment Target 52 participants
Start Date 2018-09-08
Est. Completion 2019-11-19
Phase Phase 1
Aldeyra Therapeutics

26 total trials

What the finished NCT03660878 record still lists

NCT03660878 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower).

The record links to 0 conditions, and to 3 interventions - of which Vehicle Ophthalmic Solution is the first listed.

NCT03660878 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03660878 about?

NCT03660878 is a clinical study titled "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.

What is the current status of trial NCT03660878?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2018-09-08. Estimated completion is 2019-11-19.

What interventions are being tested in trial NCT03660878?

The interventions under investigation include: Vehicle Ophthalmic Solution (DRUG), Reproxalap Ophthalmic Solution (0.25%) (DRUG), Reproxalap Ophthalmic Solution (0.5%) (DRUG).

Who is sponsoring clinical trial NCT03660878?

This trial is sponsored by Aldeyra Therapeutics, which has 26 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03660878's enrollment target sits among peer trials

52 956th of 2000 higher than 1,032 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03660878, the US trial registry maintained by the National Library of Medicine. NCT03660878 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.