CompletedNot Applicable

Evaluation of SYSTANE® BALANCE in Dry Eye Subjects With Lipid Deficiency

91 participantsStarted 2012-12

Plain-language summary

The purpose of this study is to evaluate the repeated use of SYSTANE® BALANCE on stabilizing the tear film of dry eye patients with an unstable tear film.

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: * Non-contact lens wearer; * Symptomatology as defined by the Ocular Surface Disease Index (OSDI) questionnaire; * Lipid deficiency; * Best visual acuity of 6/9 or better in each eye; * Willingness to adhere to the instructions set in the clinical protocol; * Signature of the subject informed consent form; * Other protocol-defined inclusion criteria may apply. Exclusion Criteria: * Use of systemic medication which might produce dry eye side effects; * Systemic disease which might produce dry eye side effects; * Active or recent ocular inflammation or infection; * Use of ocular medication; * Significant ocular anomaly; * Previous ocular surgery; * Previous use of Restasis; * Any medical condition that might be prejudicial to the study; * Pregnant or lactating; * 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

Mean Bulbar Conjunctival Staining

Timeframe: Month 1

Trial details

NCT IDNCT01688726

SponsorAlcon Research

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-11

Results submitted2014-11-11

View on ClinicalTrials.gov More Dry Eye Syndrome 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.