Back to resultsEvaluation of Comfort of Ocular Lubricants in Symptomatic Contact Lens Wearers
Primary Purpose
Dry Eye
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
OTF Ocular Lubricant
Ocular Lubricant
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye
Eligibility Criteria
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.
Sites / Locations
- School of Optometry and Vision
- Deakin Collaborative Eye Care Clinic, Deakin University
- School of Optometry and Vision Science, University of Waterloo
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
OTF Test 1
OTF Test 2
OTF Test 3
Ocular lubricant
Arm Description
One application of ocular lubricant to each eye at night for 5 consecutive nights
One application of ocular lubricant to each eye at night for 5 consecutive nights
One application of ocular lubricant to each eye at night for 5 consecutive nights
One drop of ocular lubricant applied to each eye at night for 5 consecutive nights
Outcomes
Primary Outcome Measures
Ocular comfort
Comfort will be rated using a visual analog scale (0-100) from 0-100, where 0=poor and 100=excellent.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05741216
Brief Title
Evaluation of Comfort of Ocular Lubricants in Symptomatic Contact Lens Wearers
Official Title
Evaluation of Comfort of Ocular Lubricants in Symptomatic Contact Lens Wearers
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
October 2, 2023 (Actual)
Study Completion Date
October 2, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OTF Test 1
Arm Type
Experimental
Arm Description
One application of ocular lubricant to each eye at night for 5 consecutive nights
Arm Title
OTF Test 2
Arm Type
Experimental
Arm Description
One application of ocular lubricant to each eye at night for 5 consecutive nights
Arm Title
OTF Test 3
Arm Type
Experimental
Arm Description
One application of ocular lubricant to each eye at night for 5 consecutive nights
Arm Title
Ocular lubricant
Arm Type
Active Comparator
Arm Description
One drop of ocular lubricant applied to each eye at night for 5 consecutive nights
Intervention Type
Other
Intervention Name(s)
OTF Ocular Lubricant
Intervention Description
Ocular lubricant in 1 of 3 test formulations
Intervention Type
Other
Intervention Name(s)
Ocular Lubricant
Other Intervention Name(s)
SYSTANE™ Gel, Genteal™ Gel
Intervention Description
Commercially available ocular lubricant
Primary Outcome Measure Information:
Title
Ocular comfort
Description
Comfort will be rated using a visual analog scale (0-100) from 0-100, where 0=poor and 100=excellent.
Time Frame
Up to Day 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Lead, Dry Eye
Organizational Affiliation
Alcon Research, LLC
Official's Role
Study Director
Facility Information:
Facility Name
School of Optometry and Vision
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2052
Country
Australia
Facility Name
Deakin Collaborative Eye Care Clinic, Deakin University
City
Waurn Ponds
State/Province
Victoria
ZIP/Postal Code
3216
Country
Australia
Facility Name
School of Optometry and Vision Science, University of Waterloo
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L3G1
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Comfort of Ocular Lubricants in Symptomatic Contact Lens Wearers
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