Photobiomodulation in Combination With Topical Cyclosporine A or Tacrolimus

NCT07239128 | Completed Early Phase 1

• 1 other identifier: 29/20092016
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

Brief 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)

Keywords

Topical Cyclosporine A; Topical Tacrolimus; Low-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.

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

LLLT-Tacrolimus

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. Tacrolimus 0.1% twice per day.

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

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-CsA; LLLT-Tacrolimus

Topical Cyclosporine A DRUG

CsA 0.1% twice per day

CsA; LLLT-CsA

Topical tacrolimus DRUG

Tacrolimus 0.1% twice per day

LLLT-Tacrolimus; Tacrolimus

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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:

• (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.

Sponsors & Collaborators

• University of Seville: lead
• Centro Oculistico Borroni: collaborator

Study Sites (2)

Biomeeting Day Surgery center

Reggio Calabria, Calabria, 89123, Italy

Location

Centro Oculistico Borroni

Gallarate, Varese, 21013, Italy

Location

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: 40467022 BACKGROUND

• 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: 39096028 BACKGROUND

• Moawad P, Shamma R, Hassanein D, Ragab G, El Zawahry O. Evaluation of the effect of topical tacrolimus 0.03% versus cyclosporine 0.05% in the treatment of dry eye secondary to Sjogren syndrome. Eur J Ophthalmol. 2022 Jan;32(1):673-679. doi: 10.1177/1120672121992680. Epub 2021 Feb 2.

  PMID: 33530719 BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Low-Level Light Therapy; Cyclosporine; Tacrolimus

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Macrolides; Lactones; Organic Chemicals

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

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

Model Details: Active-controlled (CsA and Tacrolimus)

Study Record Dates

• First Submitted: November 15, 2025
• First Posted: November 20, 2025
• Study Start: May 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-10

Locations

IT (2)