Evaluation of Comfort in Symptomatic Contact Lens Wearers

The purpose of this study is to evaluate the comfort of an ocular lubricant in symptomatic contact lens wearers. This study will be conducted in Canada.

Study Overview

• Status: Completed
• Conditions: Ocular Comfort
• Intervention / Treatment: Other: FID123238

Detailed Description

The duration of individual participation is six days.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L 3G1
      • Alcon Investigative Site 6189

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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;
• Is able to achieve 20/40 or better monocular VA with habitual contact lenses;
• Has a pair of spectacles for vision correction.
• 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-defined exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FID123238; FID123238 applied to the ocular surface, 1 application per day, for five consecutive days	Other: FID123238; Lubricant applied to the ocular surface

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comfort, collected for each eye	A visual analogue scale will be used	Up to Day 6

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): July 22, 2021
• Primary Completion (Actual): October 29, 2021
• Study Completion (Actual): October 29, 2021

Study Registration Dates

• First Submitted: July 6, 2021
• First Submitted That Met QC Criteria: July 6, 2021
• First Posted (Actual): July 15, 2021

Study Record Updates

• Last Update Posted (Actual): November 3, 2021
• Last Update Submitted That Met QC Criteria: November 2, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Contact Lenses
• Other Study ID Numbers: DEJ475-E003

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