Dry Eye Syndrome (DES), Ocular Surface Disease
Conditions
Keywords
dry eye disease, Artificial tears, Systane Complete, Tear break-up time, Thealoz Duo, Non-inferiority trial, Ocular Surface Disease Index (OSDI)
Brief 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.
Interventions
DRUGSystane 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.
DRUGThealoz 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.
Sponsors
Instituto Internacional de Medicina y Terapia (IIMET)
Hospital Puerta de Hierro, Zapopan
Centro de Retina Médica y Quirúrgica S.C.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open-label design due to differences in commercial presentation and dosing frequency of the study medications.
Intervention model description
Randomized, parallel-group, active-controlled, non-inferiority trial comparing twice-daily Systane Complete with four-times-daily Thealoz Duo over 30 days in adults with mild to moderate dry eye disease.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 participation or interfere with interpretation of study outcomes, as judged by the investigators. * Women of childbearing potential not using stable contraceptive methods for at least 30 days prior to enrollment and throughout the study duration.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Ocular Surface Disease Index (OSDI) score from baseline to day 30 | From baseline (day 0) to day 30 of treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in tear break-up time (TBUT) from baseline to day 30 | Baseline and day 30 after start of treatment | 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. |
| Change in Schirmer test value from baseline to day 30 | Baseline and day 30 after start of treatment | 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. |
| Change in Oxford corneal and conjunctival staining score from baseline to day 30 | Baseline and day 30 after start of treatment | 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. |
| Treatment adherence over 30 days of follow-up | Day 15 and day 30 of treatment | 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. |
Countries
Mexico
Contacts
PRINCIPAL_INVESTIGATORDalia Denisse Ng-Aleman, MD
Hospital Puerta de Hierro
Outcome results
None listed