Trials Sponsors Conditions Drugs Pricing

Conditions

Dry Eye Disease (DED)

Keywords

Topical Cyclosporine ATopical TacrolimusLow-level light therapy

Outcome Measures

Primary Outcomes (1)

Ocular surface disease index (OSDI)
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 Outcomes (2)

Non-invasive tear film break-up time (NIBUT)
From baseline visit to the end of follow-up (12 months)
Tear meniscus height (TMH)
From baseline visit to the end of follow-up (12 months)

Study Arms (4)

CsA

ACTIVE COMPARATOR

CsA 0.1% twice per day

Drug: Topical Cyclosporine A

Tacrolimus

ACTIVE COMPARATOR

Tacrolimus 0.1% twice per day

Drug: Topical tacrolimus

LLLT-CsA

EXPERIMENTAL

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.

Interventions

Low-level light therapy (LLLT)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.

Also known as: Photobiomodulation

LLLT-CsALLLT-Tacrolimus

Topical Cyclosporine ADrug

Eligibility Criteria

Age25 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

(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.

You may not qualify if:

Sponsors & Collaborators

Centro Oculistico Borroni
Othercollaborator
University of Seville
Otherlead

Study Sites (2)

Biomeeting Day Surgery center

Reggio Calabria, Calabria, 89123, Italy

Centro Oculistico Borroni

Gallarate, Varese, 21013, Italy

Related Publications (3)

Jones L, Craig JP, Markoulli M, Karpecki P, Akpek EK, Basu S, Bitton E, Chen W, Dhaliwal DK, Dogru M, Gomes JAP, Koehler M, Mehta JS, Perez VL, Stapleton F, Sullivan DA, Tauber J, Tong L, Trave-Huarte S, Wolffsohn JS; TFOS Collaborator Group. TFOS DEWS III: Management and Therapy. Am J Ophthalmol. 2025 Nov;279:289-386. doi: 10.1016/j.ajo.2025.05.039. Epub 2025 Jun 2.
PMID: 40467022BACKGROUND
Antwi A, Schill AW, Redfern R, Ritchey ER. Effect of low-level light therapy in individuals with dry eye disease. Ophthalmic Physiol Opt. 2024 Nov;44(7):1464-1471. doi: 10.1111/opo.13371. Epub 2024 Aug 2.
PMID: 39096028BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Low-Level Light TherapyCyclosporineTacrolimus

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapyCyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic Compounds

Study Officials

Davide Borroni, MD, PhD
Department of Ophthalmology, Riga Stradins University, Riga, Latvia
PRINCIPAL INVESTIGATOR
Antonio Spinelli, MD
Biomeeting Day Surgery center
PRINCIPAL INVESTIGATOR

Enrollment

160 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: early phase 1
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details: Participants were masked to CsA and Tacrolimus, but not to LLLT.
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: OD, PhD

Study Record Dates

First Submitted

November 15, 2025

First Posted

November 20, 2025

Study Start

Photobiomodulation in Combination With Topical Cyclosporine A or Tacrolimus

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (4)

CsA

Tacrolimus

LLLT-CsA

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Publications (3)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

LLLT-Tacrolimus

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (4)

CsA

Tacrolimus

LLLT-CsA

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Publications (3)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

LLLT-Tacrolimus

Source record

Documents

Locations