Twice-Daily Systane Complete Versus Four-Times-Daily Thealoz Duo for Dry Eye Disease (NCT07722650) | Clinical Trial Compass
CompletedNot Applicable
Twice-Daily Systane Complete Versus Four-Times-Daily Thealoz Duo for Dry Eye Disease
Mexico120 participantsStarted 2025-01-06
Plain-language summary
The goal of this clinical trial is to learn whether a twice-daily dosing schedule of Systane Complete eye drops works as well as a four-times-daily dosing schedule of Thealoz Duo eye drops to treat dry eye disease in adults. The main questions it aims to answer are:
* Does twice-daily Systane Complete provide similar improvement in dry eye symptoms, measured by the Ocular Surface Disease Index (OSDI), compared with four-times-daily Thealoz Duo after 30 days of treatment?
* How do the treatments affect tear film stability, tear production, and damage to the surface of the eye?
Researchers will compare Systane Complete (used twice a day) to Thealoz Duo (used four times a day) to see if the simpler dosing schedule maintains similar benefits for symptoms and eye surface health.
Participants will be adults with mild to moderate dry eye disease who are seen in an outpatient eye clinic. They will be randomly assigned to one of the two treatment groups. All participants will use their assigned eye drops in both eyes for 30 days and will attend clinic visits at the start of the study and after 30 days. At each visit, participants will complete the OSDI questionnaire and undergo standard eye tests, including tear break-up time, Schirmer test, and grading of surface staining on the eye.
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:
* Adults (≥18 years of age) with mild to moderate dry eye disease (DED).
* Ocular Surface Disease Index (OSDI) score between 13 and 32 at baseline.
* At least one abnormal objective test of ocular surface dysfunction, defined as one or more of the following:
* Schirmer test result \< 10 mm in 5 minutes (without anesthesia), or
* Tear break-up time (TBUT) \< 10 seconds, or
* Ocular surface staining graded between stages 1 and 3 according to the Oxford scale.
* Best-corrected visual acuity of 20/200 or better in both eyes.
* Able to provide written informed consent and comply with study procedures and scheduled visits.
Exclusion Criteria:
* Pregnancy or breastfeeding.
* Participation in another clinical trial or prior participation in the present study.
* Best-corrected visual acuity worse than 20/200 in either eye.
* Active ocular disease including conjunctivitis, blepharitis, keratitis, ocular trauma, ocular surface scarring, corneal ulcers, neurotrophic keratitis, bullous keratopathy, or neoplastic disease of the ocular surface.
* Glaucoma or eyelid disorders that affect normal eyelid function.
* Advanced dry eye disease requiring second-line TFOS DEWS II therapy.
* Ocular surgery within the previous 3 months.
* Contact lens use within 15 days prior to enrollment.
* Known hypersensitivity to any component of the study medications.
* Substance dependence within the previous 2 years.
* Systemic conditions that could increase the risk of study part…
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
1
Change in Ocular Surface Disease Index (OSDI) score from baseline to day 30
Timeframe: From baseline (day 0) to day 30 of treatment
Trial details
NCT IDNCT07722650
SponsorInstituto Internacional de Medicina y Terapia (IIMET)