Safety and comfort of two new artificial tear eye drops
An Evaluation of the Safety and Tolerability of Ocular Lubricants
This will test two new artificial tear eye drops to see how safe and comfortable they are for people with moderate dry eye.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 148 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Alcon Research Industry-sponsored |
| Locations | 4 sites (Sydney, New South Wales and 3 other locations) |
| Trial ID | NCT07238699 on ClinicalTrials.gov |
What this trial studies
Adults with moderate dry eye who currently use artificial tears will be randomized in a crossover design to receive each of two investigational artificial tear formulations, with participants using one drop per eye of the assigned product during each treatment period. Each person’s total participation is approximately 21 days. Safety and tolerability will be tracked through eye examinations and participant-reported symptoms. Key exclusions include active ocular infection, recent ocular injury, and recent contact lens wear.
Who should consider this trial
Good fit: Ideal candidates are adults with moderate dry eye who currently use artificial tears, can attend all study visits, and meet the other protocol criteria.
Not a fit: People with active eye disease or infection, recent eye injury, or recent contact lens use are excluded and likely would not benefit from participation.
Why it matters
Potential benefit: If successful, the formulations could offer safer or more comfortable artificial tears for people with moderate dry eye.
How similar studies have performed: Other artificial tear formulations have commonly provided symptom relief and shown good tolerability, though each new formulation requires its own safety testing.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Sydney, New South Wales and 3 other locations
- School of Optometry and Vision — Sydney, New South Wales, Australia (Recruiting)
- Ophthalmic Trials Australia — Teneriffe, Queensland, Australia (Recruiting)
- The University of Melbourne, Department of Optometry and Vision Science — Carlton, Victoria, Australia (Recruiting)
- Deakin Collaborative Eye Care Clinic, Deakin University — Waurn Ponds, Victoria, Australia (Recruiting)
Study contacts
- Study coordinator: Alcon Call Center
- Email: alcon.medinfo@alcon.com
- Phone: 1-888-451-3937
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.