Photobiomodulation in Combination With Topical Cyclosporine A or Tacrolimus

November 15, 2025 updated by: Antonio Ballesteros Sánchez, University of Seville

Efficacy of Low-Level Light Therapy in Combination With Topical Non-Steroidal Immunosuppressants for the Treatment of Dry Eye Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Calabria
      • Reggio Calabria, Calabria, Italy, 89123
        • Biomeeting Day Surgery center
    • Varese
      • Gallarate, Varese, Italy, 21013
        • Centro Oculistico Borroni

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CsA
CsA 0.1% twice per day
Drug: Topical Cyclosporine A
CsA 0.1% twice per day
Active Comparator: Tacrolimus
Tacrolimus 0.1% twice per day
Drug: Topical tacrolimus
Tacrolimus 0.1% twice per day
Experimental: 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.
Drug: Topical Cyclosporine A
CsA 0.1% twice per day
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.
Other Names:
  • Photobiomodulation
Experimental: 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.
Drug: Topical tacrolimus
Tacrolimus 0.1% twice per day
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.
Other Names:
  • Photobiomodulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ocular surface disease index (OSDI)
Time Frame: 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.
From baseline visit to the end of follow-up (12 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non-invasive tear film break-up time (NIBUT)
Time Frame: 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.
From baseline visit to the end of follow-up (12 months)
Tear meniscus height (TMH)
Time Frame: 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.
From baseline visit to the end of follow-up (12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Seville

Collaborators

Centro Oculistico Borroni

Investigators

  • Principal Investigator: Davide Borroni, MD, PhD, Department of Ophthalmology, Riga Stradins University, Riga, Latvia
  • Principal Investigator: Antonio Spinelli, MD, Biomeeting Day Surgery center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Actual)

June 1, 2025

Study Completion (Actual)

June 1, 2025

Study Registration Dates

First Submitted

November 15, 2025

First Submitted That Met QC Criteria

November 15, 2025

First Posted (Actual)

November 20, 2025

Study Record Updates

Last Update Posted (Actual)

November 20, 2025

Last Update Submitted That Met QC Criteria

November 15, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29/20092016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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