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| Name | Class |
|---|---|
| Centro Oculistico Borroni | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CsA | Active Comparator | CsA 0.1% twice per day |
|
| Tacrolimus | Active Comparator | Tacrolimus 0.1% twice per day |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Non-invasive tear film break-up time (NIBUT) | 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) |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Davide Borroni, MD, PhD | Department of Ophthalmology, Riga Stradins University, Riga, Latvia | Principal Investigator |
| Antonio Spinelli, MD | Biomeeting Day Surgery center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biomeeting Day Surgery center | Reggio Calabria | Calabria | 89123 | Italy | ||
| Centro Oculistico Borroni |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40467022 | Background | 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. | |
| 39096028 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 13, 2025 | Oct 13, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 13, 2025 | Oct 13, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| D016572 | Cyclosporine |
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
| D003524 | Cyclosporins |
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Active-controlled (CsA and Tacrolimus)
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Participants were masked to CsA and Tacrolimus, but not to LLLT.
|
|
| Topical Cyclosporine A | Drug | CsA 0.1% twice per day |
|
| Topical tacrolimus | Drug | Tacrolimus 0.1% twice per day |
|
| Tear meniscus height (TMH) | 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) |
| Gallarate |
| Varese |
| 21013 |
| Italy |
| 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. |
| 33530719 | 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. |
| D010456 |
| Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |