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NCT06424444 (Reproxalap Ophthalmic Solution Vehicle… in Dry Eye Disease): BVCT ex-ante prediction vs. reported outcome

On 11 Jul 2024, BioinvestGPT's BVCT predicted technical success and commercial partial success for this trial. The 8 Aug 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially maybe sufficient.

Clinical Trial

NCTID
NCT06424444
Drug Name
Reproxalap Ophthalmic Solution (0.25%) Vehicle ophthalmic solution
Drug MoA
RASP inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Eye Diseases
Indication
Dry Eye Disease
Human Patients
400
Sponsor
Aldeyra Therapeutics
Phase
Phase 3

Prediction of , index 1675

Prospective Prediction
Prediction Index
1675
Prediction Date
Commercial Prediction
partial SUCCESS (commercially maybe sufficient yet mixed clinical benefit in treating ocular symptoms)
Technical Prediction
SUCCESS (statistically significant yet weak clinical benefit in treating ocular discomfort)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
28 days in advance
Readout Data Interpretation
statistically significant (p=0.004 without improvement data released (usually a sign of not strong efficacy); yet commercially sufficient for an unsaturated market
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially maybe sufficient
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Multicenter, Phase 3, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Environment Exposure Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects With Dry Eye Disease
Phase
Phase 3
Status
Completed
Enrollment
421
Lead sponsor
Aldeyra Therapeutics, Inc.
Conditions
Dry Eye Disease
Interventions
DRUG: Reproxalap ophthalmic solution (0.25%); DRUG: Vehicle ophthalmic solution
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2024-04-29
Primary completion
2024-11-03
Completion
2024-11-03
Primary outcomes
  • Subject-reported ocular discomfort score over Week 1 to Week 6 (From Day -14 to Day 43)

NCT06424444 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials