NCT06444516

Study of Safety and Performance of a Novel Ocular Lubricant in Subjects With Dry Eye Disease

A Single-Arm Study to Evaluate and Demonstrate Safety and Performance of a Novel Ocular Lubricant in Adult Subjects With Dry Eye Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 188 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate and demonstrate the efficacy and safety of an investigational ocular lubricant formulation in patients with mild to moderate dry eye disease (DED).

Detailed description

The study will consist of a Screening visit, a Baseline visit on Day 1, a remote Compliance Check on Day 14, and an Exit visit on Day 30. The expected study duration of participation for each subject is 37 days, with 30 ± 5 days of exposure to the investigational product.

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
OTHER	FID123300 ocular lubricant	Investigational ocular lubricant

Timeline

• Start date: 2024-09-04
• Primary completion: 2025-02-07
• Completion: 2025-02-07
• First posted: 2024-06-05
• Last updated: 2026-02-18
• Results posted: 2026-02-18

Locations

9 sites across 1 country: United States