Clinical Trial

Twice-Daily Systane Complete Versus Four-Times-Daily Thealoz Duo for Dry Eye Disease

Completed
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-07-19.
Trial Details
NCT Number NCT07722650
Lead Sponsor Instituto Internacional de Medicina y Terapia (IIMET)
Collaborators: Hospital Puerta de Hierro, Zapopan, Centro de Retina Médica y Quirúrgica S.C.
Conditions Dry Eye Syndrome (DES), Ocular Surface Disease
Enrollment 120 participants
Start Date 2025-01-06
Primary Completion 2025-06-30 (estimated)
Study Completion 2025-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-24