Evaluation of Comfort of Ocular Lubricants in Symptomatic Contact Lens Wearers

Not Applicable

Completed

• Conditions: Dry Eye
• Interventions: Other: OTF Ocular Lubricant; Other: Ocular Lubricant

• Registration Number: NCT05741216
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to evaluate the ocular comfort of 3 ocular lubricants and a comparator.

Detailed Description

The expected duration of subject participation is at least 7 days. This study will be conducted in Australia and Canada.

Study Timeline

• Study First Submitted: 2023-02-14
• Study First Submitted QC: 2023-02-14
• Study First Posted: 2023-02-23
• Study Start: 2023-05-01
• Status Verified: 2023-10
• Primary Completion: 2023-10-02
• Study Completion: 2023-10-02
• Last Update Submitted: 2023-10-10
• Last Update Posted: 2023-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Is able to understand and sign an approved information consent letter;
• Habitually wears daily disposable soft contact lenses in both eyes
• Uses rewetting drops on a regular basis;
• Other protocol-defined inclusion criteria may apply.

Key

Exclusion Criteria

• Routinely sleeps in habitual contact lenses;
• Has any known active ocular disease and/or infection;
• Is pregnant or lactating;
• Other protocol specified exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OTF Test 2	OTF Ocular Lubricant	One application of ocular lubricant to each eye at night for 5 consecutive nights
OTF Test 1	OTF Ocular Lubricant	One application of ocular lubricant to each eye at night for 5 consecutive nights
OTF Test 3	OTF Ocular Lubricant	One application of ocular lubricant to each eye at night for 5 consecutive nights
Ocular lubricant	Ocular Lubricant	One drop of ocular lubricant applied to each eye at night for 5 consecutive nights

Primary Outcome Measures

Name	Time	Method
Ocular comfort	Up to Day 5	Comfort will be rated using a visual analog scale (0-100) from 0-100, where 0=poor and 100=excellent.

Trial Locations

Locations (3)

School of Optometry and Vision Science, University of Waterloo; 🇨🇦 Waterloo, Ontario, Canada

School of Optometry and Vision; 🇦🇺 Sydney, New South Wales, Australia

Deakin Collaborative Eye Care Clinic, Deakin University; 🇦🇺 Waurn Ponds, Victoria, Australia