Dry EyeNCT05131152
Microvascular and Inflammatory Responses of 0.05 Cyclosporine Eye Drop (II) in Treatment of Dry Eye
A study testing Cyclosporine and oculus keratograph, in vivo laser confocal microscopy, Functional slit lamp biomicroscopy in people with Dry Eye, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial summary
To explore the law of changes in ocular surface inflammation when 0.05% cyclosporine eye drops (II) is used to treat dry eye, 50 cases of mild to moderate dry eyes were included. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dry Eye
- What is being tested?
- Cyclosporine and oculus keratograph, in vivo laser confocal microscopy, Functional slit lamp biomicroscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2021to May 2024
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years old;
- meet the 2-3 grade dry eye diagnosis: 1) At least one eye has one or more ocular discomfort symptoms and OSDI score ≥23; 2) At least one eye meets one of the following two: 2 mm/5min≤Schirmer I test (no anesthesia) <10 mm/5min; BUT≤10s. 3) Corneal spotting but no extensive erosion.
Who cannot join
- Contact lens wearers;
- Allergies to the study drug;
- Active eye infections; history of serious systemic diseases;
- Pregnancy or breastfeeding;
- Receiving or starting other treatments that may interfere with the interpretation of the results;
- Participating any other clinical trials within 3 months;
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- Previous eye surgery, including laser treatment and refractive surgery;
- Need or have undergone punctal embolization or nasolacrimal duct obstruction;
- KCS secondary to the destruction of conjunctival goblet cells (such as vitamin A deficiency) ;
- Scar formation (such as cicatricial pemphigus, alkali burn, trachoma or radiation).
Trial locations and contacts
1 site in 1 country.
Jin Yuan, PHD contact
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
Yuqing Deng, MD, 18120557291, 15927646647@163.com
Jin Yuan, PHD
About this study
Official title: Microvascular and Inflammatory Responses of 0.05 Cyclosporine Eye Drop (II) in Treatment of Mild to Moderate Dry Eye
To explore the law of changes in ocular surface inflammation when 0.05% cyclosporine eye drops (II) is used to treat dry eye, 50 cases of mild to moderate dry eyes were included. The expectation is finding out whether cyclosporine has a regulatory effect on conjunctival microvascular parameters and other inflammation indicators after cyclosporine eye drops treat dry eye, and analyze the value of conjunctival microvascular indicators in dry eye immunosuppressive therapy.
Read the detailed description
Dry eye is a common ocular surface disease that affects people's visual function and quality of life. In recent years, with the changes of lifestyles, the prevalence of dry eye is gradually increased. According to the consensus definition of Chinese dry eye experts in 2020, dry eye is a chronic ocular surface disease caused by multiple factors, while inflammation is emphasized as an important role in the occurrence and development of dry eye. Therefore, in addition to use artificial tears to alleviate the symptoms of dry eye, it is clinically recommended to combine low-concentration ocular surface hormones or immunosuppressant for anti-inflammatory therapy. As an immunosuppressant, cyclosporine can inhibit the infiltration of CD4+ T cells on the ocular surface, inhibit the apoptosis of conjunctival goblet and lacrimal gland acinar cells, and effectively alleviate ocular surface inflammation. In addition, cyclosporine can inhibit the calcineurin pathway by forming an intracellular complex with cyclophilin, promote the production of tears, and increase the density of goblet cells. Cyclosporine has an impact on many molecules in the immune pathway of dry eye.
However, how to use and adjust immunosuppressant according to the ocular surface inflammation still depends on the subjective experience of doctors, and there is no uniform standard. Therefore, finding biological reference indicators for ocular surface inflammation is the key to promoting the standardization and precision of anti-inflammatory drugs. The stimulation of inflammation factors can lead to the expansion of the capillary network, thus, the function of ocular surface capillaries can be used as an important indicator of ocular surface inflammation. Now, the intelligent analysis technology based on ocular surface micro vessels owned by my research team can clearly obtain blood flow imagines and topographic maps of blood vessel distribution in conjunctival micro vessels, and quantify the changes in microvascular shape, density and complexity, which is a kind of non-contact and convenient evaluation method. In our previous studies, it was confirmed that the treatment of moderate to severe dry eye with low concentrations of ocular surface hormones can cause changes of ocular surface microvascular parameters. Investigators hope to further observe the temporal and spatial changes of ocular surface microvascular function during the treatment of dry eye with cyclosporine, and correlation with inflammatory cells, inflammatory factors and neuroinflammation, explore the effect of the drug on dry eye related inflammation target issues and the guiding value of conjunctival microvascular indicators in dry eye immunosuppressive therapy, in order to change the previous dry eye anti-inflammatory treatment and the mode of medication based on the doctor's personal experience.
- Conditions
- Dry Eye
- Being tested
- Cyclosporine, oculus keratograph, in vivo laser confocal microscopy, Functional slit lamp biomicroscopy
- Keywords
- dry eye, conjunctival micro-circulation, inflammation
- Medical subject headings
- Dry Eye Syndromes, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclosporineDrug
0.05% cyclosporine Eye Drops; Sodium Hyaluronate Eye Drops, 0.02% Fluoromethalone Eye Drops.
oculus keratograph, in vivo laser confocal microscopy, Functional slit lamp biomicroscopyDevice
oculus keratograph, in vivo laser confocal microscopy, Functional slit lamp biomicroscopy
| Study group | Role | What they receive |
|---|---|---|
| cyclosporine group | Experimental | Mild DE patients: topical usage of 0.05% cyclosporine Eye Drops BID + 0.1% Sodium Hyaluronate Eye Drops QID, both use for 16 weeks.
Moderate DE patients: topical usage of 0.05% cyclosporine Eye Drops BID +0.1% Sodium Hyaluronate Eye Drops QID, both use for 16 weeks, and 0.02% Fluoromethalone Eye Drops BID for 4 weeks. Receives: Drug: Cyclosporine; Device: oculus keratograph, in vivo laser confocal microscopy, Functional slit lamp biomicroscopy |
| control group | Experimental | Mild DE patients: 0.1% Sodium Hyaluronate Eye Drops QID for 16 weeks Moderate DE patients: 0.02% Fluoromethalone Eye Drops BID for 4 weeks +0.1% Sodium Hyaluronate Eye Drops QID for 16 weeks. Receives: Device: oculus keratograph, in vivo laser confocal microscopy, Functional slit lamp biomicroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conjunctival microvascular blood flow velocity
Achieved by Functional slit lamp Biomicroscopy: a traditional slit lamp (HAAG-STREIT SWISS MADE 900.7.2.34925) with a digital. camera (Canon 60D. Canon Inc, Melville, NY) and a custom software.
Measured: 12 weeks after commencement of treatment-16 weeks after commencement of treatment
Secondary outcomes (1)
Tear collection and analysis
After communicating with the patient, 5 μL of tear fluid was collected with a 5 μL capillary tear collector at the medial and lateral canthus (collected three times per eye and mixed the tears from the left and right eyes into one centrifuge tube). The sample was transferred into Centrifuge tubes and stored at -80 °C until further analysis. Cytokine concentrations were measured using microsphere-based immunoassay analysis.
Measured: 12 weeks after commencement of treatment-16 weeks after commencement of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start1 Dec 2021
- Primary completionJul 2023 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- More trials run by Zhongshan Ophthalmic Center, Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The recruitment of subjects must meet the diagnosis criteria of DEWS.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05131152
- Sponsor's protocol ID
- 2021KYPJ186
- Status last verified
- Feb 2022
- First submitted
- 10 Nov 2021
- Last updated
- 11 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microvascular and Inflammatory Responses of 0.05 Cyclosporine Eye Drop (II) in Treatment of Mild to Moderate Dry Eye
- ClinicalTrials.gov ID
- NCT05131152
- Acronym / sponsor ID
- 2021KYPJ186
- Conditions
- Dry Eye
- Keywords
- dry eye, conjunctival micro-circulation, inflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 23 Nov 2021 (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.
To explore the law of changes in ocular surface inflammation when 0.05% cyclosporine eye drops (II) is used to treat dry eye, 50 cases of mild to moderate dry eyes were included. The expectation is finding out whether cyclosporine has a regulatory effect on conjunctival microvascular parameters and other inflammation indicators after cyclosporine eye drops treat dry eye, and analyze the value of conjunctival microvascular indicators in dry eye immunosuppressive therapy.
Detailed description
Dry eye is a common ocular surface disease that affects people's visual function and quality of life. In recent years, with the changes of lifestyles, the prevalence of dry eye is gradually increased. According to the consensus definition of Chinese dry eye experts in 2020, dry eye is a chronic ocular surface disease caused by multiple factors, while inflammation is emphasized as an important role in the occurrence and development of dry eye. Therefore, in addition to use artificial tears to alleviate the symptoms of dry eye, it is clinically recommended to combine low-concentration ocular surface hormones or immunosuppressant for anti-inflammatory therapy. As an immunosuppressant, cyclosporine can inhibit the infiltration of CD4+ T cells on the ocular surface, inhibit the apoptosis of conjunctival goblet and lacrimal gland acinar cells, and effectively alleviate ocular surface inflammation. In addition, cyclosporine can inhibit the calcineurin pathway by forming an intracellular complex with cyclophilin, promote the production of tears, and increase the density of goblet cells. Cyclosporine has an impact on many molecules in the immune pathway of dry eye.
However, how to use and adjust immunosuppressant according to the ocular surface inflammation still depends on the subjective experience of doctors, and there is no uniform standard. Therefore, finding biological reference indicators for ocular surface inflammation is the key to promoting the standardization and precision of anti-inflammatory drugs. The stimulation of inflammation factors can lead to the expansion of the capillary network, thus, the function of ocular surface capillaries can be used as an important indicator of ocular surface inflammation. Now, the intelligent analysis technology based on ocular surface micro vessels owned by my research team can clearly obtain blood flow imagines and topographic maps of blood vessel distribution in conjunctival micro vessels, and quantify the changes in microvascular shape, density and complexity, which is a kind of non-contact and convenient evaluation method. In our previous studies, it was confirmed that the treatment of moderate to severe dry eye with low concentrations of ocular surface hormones can cause changes of ocular surface microvascular parameters. Investigators hope to further observe the temporal and spatial changes of ocular surface microvascular function during the treatment of dry eye with cyclosporine, and correlation with inflammatory cells, inflammatory factors and neuroinflammation, explore the effect of the drug on dry eye related inflammation target issues and the guiding value of conjunctival microvascular indicators in dry eye immunosuppressive therapy, in order to change the previous dry eye anti-inflammatory treatment and the mode of medication based on the doctor's personal experience.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The recruitment of subjects must meet the diagnosis criteria of DEWS.
| Arm | Type | Receives |
|---|---|---|
| cyclosporine group | Experimental | Drug: Cyclosporine, Device: oculus keratograph, in vivo laser confocal microscopy, Functional slit lamp biomicroscopyMild DE patients: topical usage of 0.05% cyclosporine Eye Drops BID + 0.1% Sodium Hyaluronate Eye Drops QID, both use for 16 weeks. Moderate DE patients: topical usage of 0.05% cyclosporine Eye Drops BID +0.1% Sodium Hyaluronate Eye Drops QID, both use for 16 weeks, and 0.02% Fluoromethalone Eye Drops BID for 4 weeks. |
| control group | Experimental | Device: oculus keratograph, in vivo laser confocal microscopy, Functional slit lamp biomicroscopyMild DE patients: 0.1% Sodium Hyaluronate Eye Drops QID for 16 weeks Moderate DE patients: 0.02% Fluoromethalone Eye Drops BID for 4 weeks +0.1% Sodium Hyaluronate Eye Drops QID for 16 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-65 years old;
- meet the 2-3 grade dry eye diagnosis: 1) At least one eye has one or more ocular discomfort symptoms and OSDI score ≥23; 2) At least one eye meets one of the following two: 2 mm/5min≤Schirmer I test (no anesthesia) <10 mm/5min; BUT≤10s. 3) Corneal spotting but no extensive erosion.
Key exclusion criteria (10 listed)
- Contact lens wearers;
- Allergies to the study drug;
- Active eye infections; history of serious systemic diseases;
- Pregnancy or breastfeeding;
- Receiving or starting other treatments that may interfere with the interpretation of the results;
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 |
|---|---|---|
| Cyclosporine0.05% cyclosporine Eye Drops; Sodium Hyaluronate Eye Drops, 0.02% Fluoromethalone Eye Drops. | Drug | cyclosporine group |
| oculus keratograph, in vivo laser confocal microscopy, Functional slit lamp biomicroscopyoculus keratograph, in vivo laser confocal microscopy, Functional slit lamp biomicroscopy | Device | control group, cyclosporine group |
Primary outcome
Conjunctival microvascular blood flow velocity
Time frame: 12 weeks after commencement of treatment-16 weeks after commencement of treatment
Achieved by Functional slit lamp Biomicroscopy: a traditional slit lamp (HAAG-STREIT SWISS MADE 900.7.2.34925) with a digital. camera (Canon 60D. Canon Inc, Melville, NY) and a custom software.
1 secondary outcome
Tear collection and analysis
Time frame: 12 weeks after commencement of treatment-16 weeks after commencement of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
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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.
Jin Yuan, PHD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cyclosporine and oculus keratograph, in vivo laser confocal microscopy, Functional slit lamp biomicroscopy in people with Dry Eye, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
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 2 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 11 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuqing Deng, MD (18120557291, 15927646647@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conjunctival microvascular blood flow velocity (time frame: 12 weeks after commencement of treatment-16 weeks after commencement of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Feb 2022.