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Twice-Daily Systane Complete Versus Four-Times-Daily Thealoz Duo for Dry Eye Disease
Sponsor: Instituto Internacional de Medicina y Terapia (IIMET)
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.
Official title: Twice-Daily Systane Complete Versus Four-Times-Daily Thealoz Duo for Dry Eye Disease: A Randomized Controlled Non-Inferiority Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2025-01-06
Completion Date
2025-06-30
Last Updated
2026-07-23
Healthy Volunteers
No
Interventions
Systane Complete
Systane Complete is a commercially available lipid-containing artificial tear formulation that combines mineral oils with nano-droplet lipid technology to support all three layers of the tear film (lipid, aqueous, and mucin). In this study, participants assigned to this intervention will instill one to two drops in each eye twice daily for 30 days, maintaining a minimum interval of eight hours between doses and avoiding additional topical ophthalmic medications during the study period unless clinically necessary and documented by investigators.
Thealoz Duo
Thealoz Duo is a commercially available ophthalmic solution that combines hyaluronic acid with trehalose to protect the ocular surface and support epithelial recovery in dry eye disease. In this study, participants assigned to this intervention will instill one to two drops in each eye four times daily for 30 days, maintaining a minimum interval of four hours between doses and avoiding additional topical ophthalmic medications during the study period unless clinically necessary and documented by investigators.
Locations (1)
Hospital Puerta de Hierro
Zapopan, Jalisco, Mexico