Dry Eye Disease (DED)Early Phase 1NCT07239128
Photobiomodulation in Combination With Topical Cyclosporine A or Tacrolimus
A Early Phase 1 study testing Low-level light therapy (LLLT), Topical Cyclosporine A and Topical tacrolimus in people with Dry Eye Disease (DED), run by University of Seville at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Dry Eye Disease (DED)
- What is being tested?
- Low-level light therapy (LLLT), Topical Cyclosporine A and Topical tacrolimus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesItaly
- Study dates
- 1 May 2024to 1 Jun 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Centro Oculistico Borroni
Gallarate, Varese, 21013
Biomeeting Day Surgery center
Reggio Calabria, Calabria, 89123
About this study
Official title: 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.
- Conditions
- Dry Eye Disease (DED)
- Being tested
- Low-level light therapy (LLLT), Topical Cyclosporine A, Topical tacrolimus
- Keywords
- Topical Cyclosporine A, Topical Tacrolimus, Low-level light therapy
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-level light therapy (LLLT)Device
Also called Photobiomodulation
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.
Topical Cyclosporine ADrug
CsA 0.1% twice per day
Topical tacrolimusDrug
Tacrolimus 0.1% twice per day
| Study group | Role | What they receive |
|---|---|---|
| CsA | Active comparator | CsA 0.1% twice per day Receives: Drug: Topical Cyclosporine A |
| Tacrolimus | Active comparator | Tacrolimus 0.1% twice per day Receives: 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. Receives: 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. Receives: Device: Low-level light therapy (LLLT); Drug: Topical tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline visit to the end of follow-up (12 months)
Secondary outcomes (2)
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.
Measured: From baseline visit to the end of follow-up (12 months)
Tear meniscus height (TMH)
TMH is a quantitative parameter used to assess tear volume. Reduced TMH values are indicative of aqueous tear deficiency.
Measured: From baseline visit to the end of follow-up (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start1 May 2024
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dry Eye Disease (DED)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Active-controlled (CsA and Tacrolimus)
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Oculistico Borroni
- Responsible party
- Principal investigator, Antonio Ballesteros Sánchez, University of Seville
- Investigators
- Davide Borroni, MD, PhD, Principal investigator, Department of Ophthalmology, Riga Stradins University, Riga, LatviaAntonio Spinelli, MD, Principal investigator, Biomeeting Day Surgery center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07239128
- Sponsor's protocol ID
- 29/20092016
- Status last verified
- Oct 2025
- First submitted
- 15 Nov 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40467022Antwi 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.
PubMed 39096028Moawad 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.
PubMed 33530719
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Low-Level Light Therapy in Combination With Topical Non-Steroidal Immunosuppressants for the Treatment of Dry Eye Disease
- ClinicalTrials.gov ID
- NCT07239128
- Acronym / sponsor ID
- 29/20092016
- Conditions
- Dry Eye Disease (DED)
- Keywords
- Topical Cyclosporine A, Topical Tacrolimus, Low-level light therapy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Collaborators
- Centro Oculistico Borroni
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Active-controlled (CsA and Tacrolimus)
| Arm | Type | Receives |
|---|---|---|
| CsA | Active comparator | Drug: Topical Cyclosporine ACsA 0.1% twice per day |
| Tacrolimus | Active comparator | Drug: Topical tacrolimusTacrolimus 0.1% twice per day |
| LLLT-CsA | Experimental | Device: Low-level light therapy (LLLT), Drug: Topical Cyclosporine AThree 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 | Device: Low-level light therapy (LLLT), Drug: Topical tacrolimusThree 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. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-level light therapy (LLLT)Also: PhotobiomodulationThree 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. | Device | LLLT-CsA, LLLT-Tacrolimus |
| Topical Cyclosporine ACsA 0.1% twice per day | Drug | CsA, LLLT-CsA |
| Topical tacrolimusTacrolimus 0.1% twice per day | Drug | LLLT-Tacrolimus, Tacrolimus |
Primary outcome
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.
2 secondary outcomes
Non-invasive tear film break-up time (NIBUT)
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Background: PubMed 40467022Jones 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.
- Background: PubMed 39096028Antwi 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.
- Background: PubMed 33530719Moawad 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Davide Borroni, MD, PhD principal investigator
Department of Ophthalmology, Riga Stradins University, Riga, Latvia
Antonio Spinelli, MD principal investigator
Biomeeting Day Surgery center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Low-level light therapy (LLLT), Topical Cyclosporine A and Topical tacrolimus in people with Dry Eye Disease (DED), run by University of Seville at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular surface disease index (OSDI) (time frame: From baseline visit to the end of follow-up (12 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07239128, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.