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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Aldeyra Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Allergic Conjunctivitis

Interventions

Type	Name	Description
DRUG	Reproxalap Ophthalmic Solution (0.25%)	Reproxalap Ophthalmic Solution (0.25%) administered four times a day and an additional four times a day on an as needed basis.
DRUG	Reproxalap Ophthalmic Solution (0.5%)	Reproxalap Ophthalmic Solution (0.5%) administered four times a day and an additional four times a day on an as needed basis.
DRUG	Vehicle Ophthalmic Solution	Vehicle Ophthalmic Solution administered four times a day and an additional four times a day on an as needed basis.

Timeline

• Start date: 2018-09-08
• Primary completion: 2019-11-19
• Completion: 2019-11-19
• First posted: 2018-09-07
• Last updated: 2025-04-08
• Results posted: 2025-04-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study