Status:
TERMINATED
Evaluation of the Safety and Tolerability of Ocular Lubricants
Lead Sponsor:
Alcon Research
Conditions:
Dry Eye Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of three new artificial tear formulations in subjects with moderate dry eye disease.
Detailed Description
This study will be conducted in 2 stages. In Stage 1, subjects will attend a total of 10 scheduled visits: one Screening visit, four Investigational Product visits, four 12-hour Follow Up visits (one ...
Eligibility Criteria
Inclusion
- Key
- Willing and able to understand and sign an Ethics Committee-approved informed consent form.
- Willing and able to attend all study visits as required by the protocol.
- Exhibits symptoms of dry eye at the Screening Visit.
- Currently uses habitual artificial tears to alleviate dry eye symptoms.
- Willing and able to maintain similar environmental conditions throughout the study (for example, avoid extreme changes in humidity/temperature, avoid windy conditions) and refrain from swimming on Investigational Product visit days.
- Other protocol-specified inclusion criteria may apply.
- Key
Exclusion
- Has any known active ocular disease and/or infection.
- Has any known infection or inflammation that requires treatment or has a systemic condition that in the opinion of the investigator, may affect a study outcome variable.
- Has had an ocular injury to either eye in the past 12 weeks prior to screening.
- Currently wears contact lenses or has a history of contact lens wear within the previous 1 month.
- Has undergone any ocular surgery (including intraocular surgery) within the past 12 months or has any ocular surgery planned during the study.
- Is pregnant, intends to become pregnant, or is breastfeeding.
- Other protocol-specified exclusion criteria may apply.
Key Trial Info
Start Date :
April 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 11 2025
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT06571656
Start Date
April 2 2025
End Date
July 11 2025
Last Update
August 17 2025
Active Locations (5)
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1
School of Optometry and Vision
Sydney, New South Wales, Australia, 2052
2
Advanced Optometry
Spring Hill, Queensland, Australia, 4000
3
Ophthalmic Trials Australia
Teneriffe, Queensland, Australia, 4005
4
The University of Melbourne, Department of Optometry and Vision Science
Carlton, Victoria, Australia, 3053