NCT06571656

Evaluation of the Safety and Tolerability of Ocular Lubricants

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and tolerability of three new artificial tear formulations in subjects with moderate dry eye disease.

Detailed description

This study will be conducted in 2 stages. In Stage 1, subjects will attend a total of 10 scheduled visits: one Screening visit, four Investigational Product visits, four 12-hour Follow Up visits (one for each Investigational Product visit), and an Exit visit. At each Investigational Product visit, subjects will receive one drop of the investigational product in each eye (2 drops total), as randomized. The first Investigational Product visit will occur 1 to 7 days after the Screening visit. A washout period of 2 to 7 days will separate each Investigational Product visit. Total individual duration of participation in Stage 1 will be 8 to 34 days. The planned enrollment for Stage 1 is 72 subjects. At the conclusion of Stage 1, an interim analysis will be conducted to help determine potential adaptations to the study design for Stage 2. This study will be conducted in Australia.

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
OTHER	FID123359 test formulation	Investigational product
OTHER	FID123360 test formulation	Investigational product
OTHER	FID123361 test formulation	Investigational product
OTHER	FID121843 ocular lubricant	Commercially available, preservative-free eye drops

Timeline

• Start date: 2025-04-02
• Primary completion: 2025-07-11
• Completion: 2025-07-11
• First posted: 2024-08-26
• Last updated: 2025-08-17

Locations

5 sites across 1 country: Australia