Evaluation of Comfort of Ocular Lubricants in Symptomatic Contact Lens Wearers

• Sponsor: Alcon Research (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05741216
• Collaborator: (none)
• Enrollment: 80
• Locations: 3
• Arms: 4
• Anticipated Duration (Months): 9
• Patients Per Site: 26.7
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Dry Eye	Other: OTF Ocular Lubricant; Other: Ocular Lubricant	N/A

Detailed Description

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of Comfort of Ocular Lubricants in Symptomatic Contact Lens Wearers
• Anticipated Study Start Date: Mar 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: OTF Test 1 One application of ocular lubricant to each eye at night for 5 consecutive nights	Other: OTF Ocular Lubricant; Ocular lubricant in 1 of 3 test formulations
Experimental: OTF Test 2 One application of ocular lubricant to each eye at night for 5 consecutive nights	Other: OTF Ocular Lubricant; Ocular lubricant in 1 of 3 test formulations
Experimental: OTF Test 3 One application of ocular lubricant to each eye at night for 5 consecutive nights	Other: OTF Ocular Lubricant; Ocular lubricant in 1 of 3 test formulations
Active Comparator: Ocular lubricant 1-2 drops of ocular lubricant applied to each eye at night for 5 consecutive nights	Other: Ocular Lubricant; Commercially available ocular lubricant; Other Names: SYSTANE™ Gel Genteal™ Gel

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Key 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	School of Optometry and Vision	Sydney	New South Wales	Australia	2052
2	Deakin Collaborative Eye Care Clinic, Deakin University	Waurn Ponds	Victoria	Australia	3216
3	School of Optometry and Vision Science, University of Waterloo	Waterloo	Ontario	Canada	N2L3G1

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Clinical Trial Lead, Dry Eye, Alcon Research, LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT05741216
• Other Study ID Numbers: DEJ475-E006
• First Posted: Feb 23, 2023
• Last Update Posted: Feb 24, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dry Eye Syndromes

Study Results

No Results Posted as of Feb 24, 2023