RecruitingNot Applicable

An Evaluation of the Safety and Tolerability of Ocular Lubricants

Australia148 participantsStarted 2026-03-04

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Treatment-Emergent Adverse Events (AEs)

Timeframe: 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.]

Number of Subjects with Biomicroscopy Findings Outside of Normal Limit

Timeframe: Visit 1/Screening (Day 1) through Exit Visit. Exit Visit will occur 4 to 20 days after Visit 1 depending on observed visit windows.

Best Corrected Visual Acuity (BCVA)

Timeframe: Visit 1/Screening (Day 1) through Exit Visit. Exit Visit will occur 4 to 20 days after Visit 1 depending on observed visit windows.

Trial details

NCT IDNCT07238699

SponsorAlcon Research

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-08

Contact for this trial

Alcon Call Center

1-888-451-3937 alcon.medinfo@alcon.com

View on ClinicalTrials.gov More Dry Eye Disease trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Treatment-Emergent Adverse Events (AEs)

Timeframe: 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.]

Number of Subjects with Biomicroscopy Findings Outside of Normal Limit

Timeframe: Visit 1/Screening (Day 1) through Exit Visit. Exit Visit will occur 4 to 20 days after Visit 1 depending on observed visit windows.

Best Corrected Visual Acuity (BCVA)

Timeframe: Visit 1/Screening (Day 1) through Exit Visit. Exit Visit will occur 4 to 20 days after Visit 1 depending on observed visit windows.