Evaluation of Safety and Tolerability of Investigational Ocular Lubricants

Not Applicable

Completed

• Conditions: Dry Eye Disease
• Interventions: Other: FID123300 ocular lubricant; Other: FID123301 ocular lubricant; Other: FID122505 ocular lubricant

• Registration Number: NCT05888519
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to evaluate investigational ocular lubricants for their safety and tolerability on subjects with mild to moderate dry eye disease.

Detailed Description

Subjects will be expected to attend a screening visit followed by 6 additional study visits. The expected duration of subject participation is approximately 3 weeks. This study will be conducted in Australia.

Study Timeline

• Study First Submitted: 2023-05-09
• Study First Submitted QC: 2023-06-02
• Study First Posted: 2023-06-05
• Study Start: 2023-07-24
• Primary Completion: 2023-09-27
• Study Completion: 2023-09-27
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-10
• Last Update Posted: 2023-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

• Sign an Informed Consent;
• Have dry eye symptoms;
• Other protocol-specified inclusion criteria may apply.

Key

Exclusion Criteria

• Ocular abnormalities;
• Active ocular infection or inflammation not associated with dry eye;
• History of ocular or intraocular surgery;
• Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
FID123300/FID123301/FID122505	FID123300 ocular lubricant	FID123300 ocular lubricant in Period 1, followed by FID12330 ocular lubricant in Period 2, followed by FID122505 ocular lubricant in Period 3, as randomized. For each period, the subject will receive one drop in each eye for one day. A 1-4 day washout will separate each period.
FID123300/FID123301/FID122505	FID123301 ocular lubricant	FID123300 ocular lubricant in Period 1, followed by FID12330 ocular lubricant in Period 2, followed by FID122505 ocular lubricant in Period 3, as randomized. For each period, the subject will receive one drop in each eye for one day. A 1-4 day washout will separate each period.
FID123300/FID123301/FID122505	FID122505 ocular lubricant	FID123300 ocular lubricant in Period 1, followed by FID12330 ocular lubricant in Period 2, followed by FID122505 ocular lubricant in Period 3, as randomized. For each period, the subject will receive one drop in each eye for one day. A 1-4 day washout will separate each period.
FID122505/FID123300/FID123301	FID122505 ocular lubricant	FID122505 ocular lubricant in Period 1, followed by FID123300 ocular lubricant in Period 2, followed by FID123301 ocular lubricant in Period 3, as randomized. For each period, the subject will receive one drop in each eye for one day. A 1-4 day washout will separate each period.
FID123301/FID122505/FID123300	FID122505 ocular lubricant	FID123301 ocular lubricant in Period 1, followed by FID122505 ocular lubricant in Period 2, followed by FID123300 ocular lubricant in Period 3, as randomized. For each period, the subject will receive one drop in each eye for one day. A 1-4 day washout will separate each period.
FID123301/FID122505/FID123300	FID123300 ocular lubricant	FID123301 ocular lubricant in Period 1, followed by FID122505 ocular lubricant in Period 2, followed by FID123300 ocular lubricant in Period 3, as randomized. For each period, the subject will receive one drop in each eye for one day. A 1-4 day washout will separate each period.
FID123301/FID122505/FID123300	FID123301 ocular lubricant	FID123301 ocular lubricant in Period 1, followed by FID122505 ocular lubricant in Period 2, followed by FID123300 ocular lubricant in Period 3, as randomized. For each period, the subject will receive one drop in each eye for one day. A 1-4 day washout will separate each period.
FID122505/FID123300/FID123301	FID123300 ocular lubricant	FID122505 ocular lubricant in Period 1, followed by FID123300 ocular lubricant in Period 2, followed by FID123301 ocular lubricant in Period 3, as randomized. For each period, the subject will receive one drop in each eye for one day. A 1-4 day washout will separate each period.
FID122505/FID123300/FID123301	FID123301 ocular lubricant	FID122505 ocular lubricant in Period 1, followed by FID123300 ocular lubricant in Period 2, followed by FID123301 ocular lubricant in Period 3, as randomized. For each period, the subject will receive one drop in each eye for one day. A 1-4 day washout will separate each period.

Primary Outcome Measures

Name	Time	Method
Best corrected visual acuity (BCVA) with manifest refraction, at distance	Day 1, each wear period. A wear period is 1 day.	BCVA will be collected for each eye individually and recorded in logarithm Minimum Angle of Resolution (logMAR)

Trial Locations

Locations (3)

George Street Eye Centre; 🇦🇺 Sydney, New South Wales, Australia

Ophthalmic Trials Australia; 🇦🇺 Teneriffe, Queensland, Australia

University of Melbourne, Department of Optometry and Vision Science; 🇦🇺 Carlton, Victoria, Australia