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Photobiomodulation in Combination With Topical Cyclosporine A or Tacrolimus

NCT07239128 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-11-20

No results posted yet for this study

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.

Conditions

  • Dry Eye Disease (DED)

Interventions

DEVICE

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.

DRUG

Topical Cyclosporine A

CsA 0.1% twice per day

DRUG

Topical tacrolimus

Tacrolimus 0.1% twice per day

Sponsors & Collaborators

  • Centro Oculistico Borroni

    collaborator OTHER

  • University of Seville

    lead OTHER

Principal Investigators

  • Davide Borroni, MD, PhD · Department of Ophthalmology, Riga Stradins University, Riga, Latvia

  • Antonio Spinelli, MD · Biomeeting Day Surgery center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2025-06-01
Completion
2025-06-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07239128 on ClinicalTrials.gov