Evaluation of Safety and Tolerability of Investigational Ocular Lubricants
Not Applicable
Completed
- Conditions
- Dry Eye Disease
- Registration Number
- NCT05888519
- Lead Sponsor
- Alcon Research
- Brief Summary
The purpose of this study is to evaluate investigational ocular lubricants for their safety and tolerability on subjects with mild to moderate dry eye disease.
- Detailed Description
Subjects will be expected to attend a screening visit followed by 6 additional study visits. The expected duration of subject participation is approximately 3 weeks. This study will be conducted in Australia.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 47
Inclusion Criteria
- Sign an Informed Consent;
- Have dry eye symptoms;
- Other protocol-specified inclusion criteria may apply.
Key
Exclusion Criteria
- Ocular abnormalities;
- Active ocular infection or inflammation not associated with dry eye;
- History of ocular or intraocular surgery;
- Other protocol-defined exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Best corrected visual acuity (BCVA) with manifest refraction, at distance Day 1, each wear period. A wear period is 1 day. BCVA will be collected for each eye individually and recorded in logarithm Minimum Angle of Resolution (logMAR)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
George Street Eye Centre
🇦🇺Sydney, New South Wales, Australia
Ophthalmic Trials Australia
🇦🇺Teneriffe, Queensland, Australia
University of Melbourne, Department of Optometry and Vision Science
🇦🇺Carlton, Victoria, Australia
George Street Eye Centre🇦🇺Sydney, New South Wales, Australia