NCT07239128

Photobiomodulation in Combination With Topical Cyclosporine A or Tacrolimus

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: University of Seville · Academic / Other
• Sex: All
• Age: 25 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2024-05-01
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2025-11-20
• Last updated: 2025-11-20

Locations

2 sites across 1 country: Italy