NCT05888519
Completed
Not Applicable
Evaluation of Safety and Tolerability of Investigational Ocular Lubricants
ConditionsDry Eye Disease
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 47
- Locations
- 3
- Primary Endpoint
- Best corrected visual acuity (BCVA) with manifest refraction, at distance
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Sign an Informed Consent;
- •Have dry eye symptoms;
- •Other protocol-specified inclusion criteria may apply.
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.
Outcomes
Primary Outcomes
Best corrected visual acuity (BCVA) with manifest refraction, at distance
Time Frame: 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 Outcomes
No secondary outcomes reported
Investigators
Study Sites (3)
Loading locations...
Similar Trials
Completed
Not Applicable
Evaluation of Safety and Tolerability of Ocular LubricantsDry EyeNCT05573360Alcon Research41
Completed
Not Applicable
Fluorophotometry Evaluation of Lubricant Eye DropsHealthyNCT00347854Alcon Research40
Terminated
Not Applicable
Evaluation of the Safety and Tolerability of Ocular LubricantsDry Eye DiseaseNCT06571656Alcon Research73
Completed
Not Applicable
Clinical Evaluation of the FluidVision Accommodating Intraocular Lens (AIOL)AphakiaNCT02049567PowerVision170
Completed
Not Applicable
Evaluation of Comfort of Ocular Lubricants in Symptomatic Contact Lens WearersDry EyeNCT05741216Alcon Research36