Photobiomodulation in Combination With Topical Cyclosporine A or Tacrolimus

University of Seville

Status and phase: Completed; Early Phase 1

Conditions: Dry Eye Disease (DED)

Treatments: Drug: Topical tacrolimus; Device: Low-level light therapy (LLLT); Drug: Topical Cyclosporine A

Study type: Interventional

Funder types: Other

Identifiers

NCT07239128

29/20092016

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: All

Ages: 25+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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160 participants in 4 patient groups

CsA

Active Comparator group

Description:

CsA 0.1% twice per day

Treatment:

Drug: Topical Cyclosporine A

Tacrolimus

Active Comparator group

Description:

Tacrolimus 0.1% twice per day

Treatment:

Drug: Topical tacrolimus

LLLT-CsA

Experimental group

Description:

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.

Treatment:

Drug: Topical Cyclosporine A

Device: Low-level light therapy (LLLT)

LLLT-Tacrolimus

Experimental group

Description:

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.

Treatment:

Device: Low-level light therapy (LLLT)

Drug: Topical tacrolimus