Evaluating new eye drops for dry eye relief
Evaluation of the Safety and Tolerability of Ocular Lubricants
This study is testing three new eye drop formulas to see if they can safely help people with moderate dry eye feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Alcon Research Industry-sponsored |
| Locations | 5 sites (Sydney, New South Wales and 4 other locations) |
| Trial ID | NCT06571656 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and tolerability of three new artificial tear formulations in individuals suffering from moderate dry eye disease. Participants will attend a series of visits where they will receive different investigational products in each eye, with a structured follow-up to monitor their responses. The study is divided into two stages, with an interim analysis planned after the first stage to inform potential adjustments for the second stage. A total of 72 subjects will be enrolled in the first stage, which will last between 8 to 34 days.
Who should consider this trial
Good fit: Ideal candidates are individuals experiencing moderate dry eye symptoms who currently use artificial tears.
Not a fit: Patients with active ocular diseases, infections, or those who wear contact lenses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatments for individuals suffering from dry eye disease.
How similar studies have performed: Other studies evaluating artificial tear formulations have shown promise, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Willing and able to understand and sign an Ethics Committee-approved informed consent form. * Willing and able to attend all study visits as required by the protocol. * Exhibits symptoms of dry eye at the Screening Visit. * Currently uses habitual artificial tears to alleviate dry eye symptoms. * Willing and able to maintain similar environmental conditions throughout the study (for example, avoid extreme changes in humidity/temperature, avoid windy conditions) and refrain from swimming on Investigational Product visit days. * Other protocol-specified inclusion criteria may apply. Key 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. * Has had an ocular injury to either eye in the past 12 weeks prior to screening. * Currently wears contact lenses or has a history of contact lens wear within the previous 1 month. * Has undergone any ocular surgery (including intraocular surgery) within the past 12 months or has any ocular surgery planned during the study. * Is pregnant, intends to become pregnant, or is breastfeeding. * Other protocol-specified exclusion criteria may apply.
Where this trial is running
Sydney, New South Wales and 4 other locations
- School of Optometry and Vision — Sydney, New South Wales, Australia (Recruiting)
- Advanced Optometry — Spring Hill, Queensland, 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 — 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.