Evaluation of Comfort of Ocular Lubricants in Symptomatic Contact Lens Wearers

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

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Other: OTF Ocular Lubricant; Other: Ocular Lubricant

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alcon Call Center; Phone Number: 1-888-451-3937; Email: alcon.medinfo@alcon.com

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2052
      • School of Optometry and Vision
  • Victoria
    • Waurn Ponds, Victoria, Australia, 3216
      • Deakin Collaborative Eye Care Clinic, Deakin University
• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L3G1
      • School of Optometry and Vision Science, University of Waterloo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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; One drop 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): October 2, 2023
• Study Completion (Actual): October 2, 2023

Study Registration Dates

• First Submitted: February 14, 2023
• First Submitted That Met QC Criteria: February 14, 2023
• First Posted (Actual): February 23, 2023

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: DEJ475-E006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No