Evaluation of Comfort in Symptomatic Contact Lens Wearers

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04963543
• Collaborator: (none)
• Enrollment: 17
• Location: 1
• Arm: 1
• Actual Duration (Months): 3.3
• Patients Per Site Per Month: 5.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Ocular Comfort	Other: FID123238	N/A

Detailed Description

The duration of individual participation is six days.

Study Design

• Study Type: Interventional
• Actual Enrollment: 17 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Evaluation of Comfort in Symptomatic Contact Lens Wearers
• Actual Study Start Date: Jul 22, 2021
• Actual Primary Completion Date: Oct 29, 2021
• Actual Study Completion Date: Oct 29, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Comfort, collected for each eye [Up to Day 6]

   A visual analogue scale will be used

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;

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alcon Investigative Site 6189	Waterloo	Ontario	Canada	N2L 3G1

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: NCT04963543
• Other Study ID Numbers: DEJ475-E003
• First Posted: Jul 15, 2021
• Last Update Posted: Nov 3, 2021
• Last Verified: Nov 1, 2021

• 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
• Keywords provided by Alcon Research: Contact Lenses

Study Results

No Results Posted as of Nov 3, 2021