An Evaluation of the Safety and Tolerability of Ocular Lubricants
- Conditions
- Dry Eye Disease
- Registration Number
- NCT07238699
- Lead Sponsor
- Alcon Research
- Brief Summary
The purpose of this study is to evaluate the safety and tolerability of two new artificial tear formulations in subjects with moderate dry eye disease.
- Detailed Description
Each subject will receive 2 investigational products (one drop per eye of each investigational product) in a cross-over study design according to a randomization schedule. Individual duration of participation will be approximately 21 days.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 148
- Subject must be willing and able to understand and sign an ethics committee approved informed consent form.
- Subject must be willing and able to attend all study visits as required by the protocol.
- Subject must exhibit symptoms of dry eye at the Screening Visit.
- Subject must currently use artificial tears.
- Other protocol-defined inclusion criteria may apply.
- 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.
- Any ocular injury to either eye in the 12 weeks prior to screening.
- Current wearer of contact lenses or has a history of contact lens wear within the previous 1 month.
- Other protocol-defined exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Number of Treatment-Emergent Adverse Events (AEs) Visit 2 [1 to 7 days after Visit 1/Screening (Day 1)] through Exit Visit. Exit Visit will occur 3 to 13 days after Visit 2 depending on observed visit windows.] An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the investigational medical device (test product). The number of adverse events as observed or reported will be recorded.
Number of Subjects with Biomicroscopy Findings Outside of Normal Limit Visit 1/Screening (Day 1) through Exit Visit. Exit Visit will occur 4 to 20 days after Visit 1 depending on observed visit windows. The investigator will observe the corneal and other ocular structures under white light of the slit lamp. The number of subjects with biomicroscopy findings outside of normal limits will be recorded.
Best Corrected Visual Acuity (BCVA) Visit 1/Screening (Day 1) through Exit Visit. Exit Visit will occur 4 to 20 days after Visit 1 depending on observed visit windows. BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts and recorded in logarithm Minimum angle of resolution (logMar).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Contact Alcon Call Center for Trial Locations
🇺🇸Fort Worth, Texas, United States
School of Optometry and Vision
🇦🇺Sydney, New South Wales, Australia
Ophthalmic Trials Australia
🇦🇺Teneriffe, Queensland, Australia
The University of Melbourne, Department of Optometry and Vision Science
🇦🇺Carlton, Victoria, Australia
Deakin Collaborative Eye Care Clinic, Deakin University
🇦🇺Waurn Ponds, Victoria, Australia
Contact Alcon Call Center for Trial Locations🇺🇸Fort Worth, Texas, United States