Photobiomodulation in Combination With Topical Cyclosporine A or Tacrolimus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2025-06-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Dry Eye Disease (DED)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Active-controlled (CsA and Tacrolimus)

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Participants were masked to CsA and Tacrolimus, but not to LLLT.

Study Groups

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LLLT-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.

Group Type EXPERIMENTAL

Low-level light therapy (LLLT)

Intervention Type DEVICE

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.

Topical tacrolimus

Intervention Type DRUG

Tacrolimus 0.1% twice per day

CsA

CsA 0.1% twice per day

Group Type ACTIVE_COMPARATOR

Topical Cyclosporine A

Intervention Type DRUG

CsA 0.1% twice per day

Tacrolimus

Tacrolimus 0.1% twice per day

Group Type ACTIVE_COMPARATOR

Topical tacrolimus

Intervention Type DRUG

Tacrolimus 0.1% twice per day

LLLT-CsA

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.

Group Type EXPERIMENTAL

Low-level light therapy (LLLT)

Intervention Type DEVICE

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.

Topical Cyclosporine A

Intervention Type DRUG

CsA 0.1% twice per day

Interventions

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Low-level light therapy (LLLT)

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.

Intervention Type DEVICE

Topical Cyclosporine A

CsA 0.1% twice per day

Intervention Type DRUG

Topical tacrolimus

Tacrolimus 0.1% twice per day

Intervention Type DRUG

Other Intervention Names

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Photobiomodulation

Eligibility Criteria

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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.

Minimum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No