NCT04207736Phase 3Completed

The INVIGORATE Trial: A Clinical Trial to Assess the Efficacy and Safety of Subjects With Seasonal Allergic Conjunctivitis.

Study sponsor: Aldeyra Therapeutics, Inc. · ALDX

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

Open ClinicalTrials.gov record CSV export · Pro

Primary completion2021-02-16Actual

Enrollment · participants95Actual

Source updated2024-11-20Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

Pro unlocks the full available history and CSV export. View Pro features

No recorded changes are available for this view and time period. Our history may be incomplete; this does not establish that the trial stayed unchanged.

Study details

Conditions studied

Allergic Conjunctivitis

Treatments or interventions studied

Reproxalap Ophthalmic Solution (0.25%)Drug
Vehicle Ophthalmic SolutionDrug

Primary outcomes · main study measures

Read the study measures

measure: Subject-Reported Ocular Itching Score Assessed Over 110 to 210 Minutes in the Allergy Chamber; description: Change from baseline comparison of reproxalap to vehicle for ocular itching on a 0 to 4 scale ( 0 = none, 4 = severe). The treatment comparison was performed using a mixed model repeated measures approach for a crossover trial with two treatment periods. The model included time point, treatment, treatment period, treatment sequence, and interaction between time point and treatment as fixed effects, and subject nested within treatment sequence as a repeated measure.; timeFrame: The efficacy assessment period was 110 to 210 minutes in the allergy chamber; baseline was pre-Dose #1 for each treatment period.

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

How to read this history