NCT03494504

ALLEVIATE Trial - A Phase 3 Trial in Subjects With Allergic Conjunctivitis

A Multi-Center, Double-Masked, Randomized, Parallel-Group, Vehicle-Controlled, Phase 3 Clinical Trial to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solutions (0.25% and 0.5%) Compared to Vehicle in the Conjunctival Allergen Challenge (Ora-CAC®) Model of Acute Allergic Conjunctivitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 318 (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, Clinical Trial to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solutions in Subjects with Acute Allergic Conjunctivitis

Conditions

• Allergic Conjunctivitis

Interventions

Type	Name	Description
DRUG	Reproxalap Ophthalmic Solution (0.25%)	Reproxalap Ophthalmic Solution (0.25%) administered once.
DRUG	Reproxalap Ophthalmic Solution (0.5%)	Reproxalap Ophthalmic Solution (0.5%) administered once.
DRUG	Vehicle Ophthalmic Solution	Vehicle Ophthalmic Solution administered once.

Timeline

• Start date: 2018-03-30
• Primary completion: 2018-11-05
• Completion: 2018-11-05
• First posted: 2018-04-11
• Last updated: 2025-02-11
• Results posted: 2025-02-11

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study