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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
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 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.
Hospital Puerta de Hierro
Zapopan, Jalisco, Mexico
Change in Ocular Surface Disease Index (OSDI) score from baseline to day 30
The Ocular Surface Disease Index (OSDI) is a validated 12-item questionnaire that measures the frequency of dry eye symptoms and their impact on visual function and daily activities. Scores range from 0 to 100, with higher scores indicating more severe symptoms. In this trial, participants complete the OSDI at baseline and after 30 days of treatment. The primary outcome is the adjusted mean OSDI score at day 30, analyzed using analysis of covariance (ANCOVA) with baseline OSDI as a covariate to compare twice-daily Systane Complete with four-times-daily Thealoz Duo within a non-inferiority framework.
Time frame: From baseline (day 0) to day 30 of treatment
Change in tear break-up time (TBUT) from baseline to day 30
Tear break-up time (TBUT) is measured using fluorescein dye as the interval in seconds between a complete blink and the first appearance of a discontinuity in the tear film. TBUT is assessed in both eyes at baseline and at day 30 under controlled environmental conditions; values from the right and left eyes are averaged to obtain a single patient-level value. The secondary outcome is the change in mean TBUT (seconds) from baseline to day 30 and the between-group comparison of TBUT at day 30.
Time frame: Baseline and day 30 after start of treatment
Change in Schirmer test value from baseline to day 30
Schirmer test without anesthesia is used to assess tear production by placing filter paper strips in the lower eyelid for 5 minutes and measuring the length of wetting in millimeters. Schirmer test is performed in both eyes at baseline and at day 30; measurements from right and left eyes are averaged to generate a single patient-level value. The secondary outcome is the change in mean Schirmer test value (millimeters) from baseline to day 30 and the between-group comparison of Schirmer values at day 30.
Time frame: Baseline and day 30 after start of treatment
Change in Oxford corneal and conjunctival staining score from baseline to day 30
Corneal and conjunctival epithelial staining is evaluated using fluorescein and graded according to the Oxford grading scale for ocular surface staining. The Oxford scale ranges from grade 0 (no staining) to grade 5 (severe staining), with higher grades indicating more extensive epithelial damage. Staining is assessed in both eyes at baseline and at day 30; scores from the right and left eyes are averaged to obtain a single patient-level value. The secondary outcome includes the change in mean Oxford staining score from baseline to day 30 and the proportion of participants achieving complete resolution of corneal staining (Oxford grade 0) at day 30 in each treatment group.
Time frame: Baseline and day 30 after start of treatment
Treatment adherence over 30 days of follow-up
Treatment adherence is evaluated using patient-completed daily treatment diaries that record each administration of the assigned study medication. Adherence (%) is calculated using the formula AD = (RA × 100) / IA, where RA is the number of recorded administrations and IA is the total number of indicated applications according to the prescribed dosing regimen. Adherence is assessed at day 15 and day 30. Participants with adherence values below 90% are considered to have protocol deviations and are excluded from the per-protocol analysis.
Time frame: Day 15 and day 30 of treatment
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