Evaluation of Comfort in Subjects With Moderate Dry Eye Disease
1 other identifier
interventional
40
1 country
1
Brief Summary
The purpose of this study is to evaluate the comfort of an ocular lubricant in dry eye subjects. This study will be conducted in Canada and Australia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2021
CompletedFirst Posted
Study publicly available on registry
April 5, 2021
CompletedStudy Start
First participant enrolled
June 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 10, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 10, 2021
CompletedNovember 16, 2021
November 1, 2021
4 months
April 1, 2021
November 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in comfort rating
A visual analogue scale will be used
Baseline, up to 12 Hours (Day 1, each product)
Study Arms (5)
Sequence 1
EXPERIMENTALFID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product.
Sequence 2
EXPERIMENTALFID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product.
Sequence 3
EXPERIMENTALFID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product.
Sequence 4
EXPERIMENTALFID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product.
Sequence 5
EXPERIMENTALFID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product.
Interventions
Lubricant applied to the ocular surface
Drops applied to the ocular surface
Eligibility Criteria
You may qualify if:
- Able to understand and sign an information consent letter
- Willing and able to follow instructions and maintain the appointment schedule
- Has dry eye symptoms
You may not qualify if:
- Has suffered any ocular injury to either eye in the past 12 weeks
- Is pregnant or lactating at the time of enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (1)
Alcon Investigator 8169
Carlton, Victoria, 3053, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trial Lead, Dry Eye
Alcon Research, LLC
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2021
First Posted
April 5, 2021
Study Start
June 30, 2021
Primary Completion
November 10, 2021
Study Completion
November 10, 2021
Last Updated
November 16, 2021
Record last verified: 2021-11