Photobiomodulation in Combination With Topical Cyclosporine A or Tacrolimus
- Conditions
- Dry Eye Disease (DED)
- Interventions
- Registration Number
- NCT07239128
- Lead Sponsor
- University of Seville
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
(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.
(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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CsA Topical Cyclosporine A CsA 0.1% twice per day Tacrolimus Topical tacrolimus Tacrolimus 0.1% twice per day LLLT-CsA Low-level light therapy (LLLT) Three 15-minute sessions of LLLT 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. LLLT-CsA Topical Cyclosporine A Three 15-minute sessions of LLLT 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. LLLT-Tacrolimus Topical tacrolimus Three 15-minute sessions of LLLT 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. Tacrolimus 0.1% twice per day. LLLT-Tacrolimus Low-level light therapy (LLLT) Three 15-minute sessions of LLLT 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. Tacrolimus 0.1% twice per day.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (2)
Biomeeting Day Surgery center
🇮🇹Reggio Calabria, Calabria, Italy
Centro Oculistico Borroni
🇮🇹Gallarate, Varese, Italy
Biomeeting Day Surgery center🇮🇹Reggio Calabria, Calabria, Italy