NCT03162783

A Randomized, Double Masked, Clinical Study of Subjects With Dry Eye Syndrome

A Single-Center, Phase 2a, Randomized, Double Masked, Clinical Study to Assess the Safety, Tolerability, and Pharmacodynamic Activity of ADX-102 Ophthalmic Solution in Subjects With Dry Eye Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Aldeyra Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the safety, tolerability, and pharmacodynamic activity of ADX-102 Ophthalmic Solutions and ADX-102 Ophthalmic Lipid Solution in subjects with dry eye syndrome.

Conditions

• Dry Eye Syndromes

Interventions

Type	Name	Description
DRUG	ADX-102 Ophthalmic Solution (0.5%)	ADX-102 Ophthalmic Solution (0.5%) administered for approximately 4 weeks.
DRUG	ADX-102 Ophthalmic Solution (0.1%)	ADX-102 Ophthalmic Solution (0.1%) administered for approximately 4 weeks.
DRUG	ADX-102 Ophthalmic Lipid Solution (0.5%)	ADX-102 Ophthalmic Lipid Solution administered for approximately 4 weeks.

Timeline

• Start date: 2017-05-15
• Primary completion: 2017-07-06
• Completion: 2017-07-06
• First posted: 2017-05-22
• Last updated: 2025-01-16
• Results posted: 2025-01-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study