Actively Recruiting
An Evaluation of the Safety and Tolerability of Ocular Lubricants
Led by Alcon Research · Updated on 2026-03-11
148
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of two new artificial tear formulations in adults with moderate dry eye disease. This interventional study aims to understand how these investigational ocular lubricants affect symptoms and eye health. Participants must currently use artificial tears and have dry eye symptoms to join the study. Participants will receive two different investigational eye drop formulations in a randomized crossover design. Each subject will use one formulation in both eyes for one day, followed by at least two days without treatment, then use the other formulation for one day. The two products being studied are named FID123440 and FID123437. The crossover allows comparison of each product's effects within the same individual. Each participant's involvement will last about 21 days, including screening, treatment periods, and follow-up visits. Researchers will monitor treatment-emergent adverse events, examine eyes with biomicroscopy for any abnormal findings, and measure best corrected visual acuity. Safety and tolerability will be assessed throughout the study, with visits scheduled from screening through an exit visit occurring up to 20 days later.
CONDITIONS
Brief Title
An Evaluation of the Safety and Tolerability of Ocular Lubricants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to understand and sign informed consent
- Willing and able to attend all required study visits
- Exhibiting symptoms of dry eye at screening
- Currently using artificial tears
- Other protocol-defined inclusion criteria may apply
You will not qualify if you...
- Known active ocular disease or infection
- Known infection or inflammation requiring treatment or systemic condition affecting study outcomes
- Ocular injury within 12 weeks prior to screening
- Current contact lens wearer or history of contact lens wear within previous 1 month
- Other protocol-defined exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 21 days
Participants receive two investigational ocular lubricant products in a cross-over design with one drop per eye of each product on separate days.
2 treatment days separated by at least 2 calendar days
Duration - Up to 20 days after screening
Participants are monitored for safety and tolerability after treatment.
Approximately 2 follow-up visits
Trial Site Locations
Total: 4 locations
1
School of Optometry and Vision
Sydney, New South Wales, Australia, 2052
Actively Recruiting
2
Ophthalmic Trials Australia
Teneriffe, Queensland, Australia, 4005
Actively Recruiting
3
The University of Melbourne, Department of Optometry and Vision Science
Carlton, Victoria, Australia, 3053
Actively Recruiting
4
Deakin Collaborative Eye Care Clinic, Deakin University
Waurn Ponds, Victoria, Australia, 3216
Actively Recruiting
Research Team
A
Alcon Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here