NCT06444529

A Double-Masked Comparison of FID 123320 Ophthalmic Solution to Vehicle for the Reduction of Ocular Redness

A Double-Masked Comparison of Apraclonidine Hydrochloride Ophthalmic Solution to Vehicle for the Reduction of Ocular Redness

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 159 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and efficacy of Apraclonidine Hydrochloride Ophthalmic Solution 0.125% when compared to Vehicle, in relieving redness of the eye due to minor eye irritations. This study will be conducted in the United States.

Detailed description

The study will consist of six (6) scheduled visits: Screening and/or Baseline Visit (Day -7 to -1), Eligibility Confirmation/Randomization/1st Treatment Visit (Day 1), Week 2 Follow-Up Visit (Day 14), Week 4 Follow-Up Visit (Day 28), Week 8 Follow-Up/Treatment Discontinuation Visit (Day 56) and Exit Visit (Day 63). The expected individual duration of participation in the study is approximately 10 weeks with approximately 56 days of exposure to the investigational product.

Conditions

• Ocular Redness

Interventions

Type	Name	Description
DRUG	Apraclonidine Hydrochloride Ophthalmic Solution	Investigational ophthalmic solution applied topically to the eye with a dropper bottle
DRUG	Vehicle	Vehicle (inactive ingredients) applied topically to the eye with a dropper bottle

Timeline

• Start date: 2024-08-21
• Primary completion: 2024-11-14
• Completion: 2025-01-08
• First posted: 2024-06-05
• Last updated: 2025-10-23

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study