Dry Eye Disease (DED)
Conditions
Keywords
Topical Cyclosporine A, Topical Tacrolimus, Low-level light therapy
Brief summary
The objective of the study is to evaluate the effectiveness of Low-level light therapy (LLLT) in combination with either topical Cyclosporine A (CsA) or topical Tacrolimus, using each non-steroidal immunosuppressant as an active control.
Interventions
Three 15-minute sessions were performed at weekly intervals. The treatment was delivered with a wavelength of 625 nm and a radiance of 35 mW/cm², resulting in a total energy dose of approximately 32 J/cm² applied to the facial and eyelid regions with eyes closed.
CsA 0.1% twice per day
Tacrolimus 0.1% twice per day
Sponsors
Centro Oculistico Borroni
University of Seville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
Participants were masked to CsA and Tacrolimus, but not to LLLT.
Intervention model description
Active-controlled (CsA and Tacrolimus)
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(1) Ocular Surface Disease Index (OSDI) score \> 13; (2) non-invasive tear film break-up time (NIBUT) \< 10 seconds; and (3) tear meniscus height \< 0.25 mm.
Exclusion criteria
(1) structural abnormalities of the eyelids; (2) active blepharitis; (3) corneal disorders that could interfere with study assessments, such as active corneal infections or corneal dystrophies; (4) active ocular allergy; (5) history of procedures for DED treatment within the previous 12 months, such as eyelid exfoliation, thermal eyelid therapies, light therapies, or quantum molecular resonance (QMR); (6) history of intraocular or laser ocular surgery within the past 5 years; (7) current use of topical antibiotics or anti-inflammatory agents; (8) diagnosis of systemic autoimmune disease; (9) contact lens wear; (10) pregnancy or lactation; and (11) inability to understand or provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular surface disease index (OSDI) | From baseline visit to the end of follow-up (12 months) | A standardized questionnaire designed to assess the symptoms of dry eye disease and their impact on vision-related functioning. It consists of 12 items that evaluate the frequency of symptoms, environmental triggers, and functional limitations over the previous week. The OSDI provides a score from 0 to 100, with higher scores indicating more severe symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Non-invasive tear film break-up time (NIBUT) | From baseline visit to the end of follow-up (12 months) | NIBUT is a clinical test used to evaluate tear film stability without the use of dyes. It measures the time interval between a complete blink and the first appearance of a disruption or break in the tear film. Shorter NIBUT values indicate reduced tear film stability. |
| Tear meniscus height (TMH) | From baseline visit to the end of follow-up (12 months) | TMH is a quantitative parameter used to assess tear volume. Reduced TMH values are indicative of aqueous tear deficiency. |
Countries
Italy
Outcome results
None listed