Dry EyeNCT05383612
To Evaluate the Efficacy of Diquafosol Sodium in the Treatment of MGD in Different Treatment Pattern
A study testing Warm compresses and 3% Diquafosol Sodium Eye Drops in people with Dry Eye and Meibomian Gland Dysfunction, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial summary
MGD is a chronic, diffuse abnormality of the meibomian glands, commonly characterized by terminal duct obstruction and/or qualitative/quantitative changes in the glandular secretion. It may result in alteration of the tear film, symptoms of eye irritation, clinically apparent inflammation, and ocular surface disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye, Meibomian Gland Dysfunction
- What is being tested?
- Warm compresses and 3% Diquafosol Sodium Eye Drops
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 5 Aug 2022to 20 May 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with FBUT<10s；
- Presence of ocular symptoms with OSDI score≥13；
- 0<The score of meibum quality or expressibility ≤2；
- 1/3≤The meibomian drop-out ≤2/3 (meiboscore ≤2)
Who cannot join
- patients diagnosed of dry eye with Sjogren syndrome or diabetic mellitus.
- Patients who wear contact lens during study or accepted refractive surgery within 6 months before screening.
- Patients who have allergy history or adverse reactions to the experimental drugs or its components.
- Patients with active ocular inflammation such as infectious keratitis or blepharitis.
- Patients who had received ocular or system steroids or immunosuppressant 2 weeks before screening.
- Patients who had received any other experimental drug 2 weeks before screening.
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- Patients with concomitant disease who were considered unable to evaluate efficacy or unlikely to complete the expected course of treatment and follow-up.
- Pregnant and lactating women, or those planning a pregnancy over the course of the study.
- Patients judged by the investigator to be unsuitable for the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center, Sun Yat-Sen University
Guangzhou, Guangdong, 510080
Saiqun Li, M.D., Ph.D., 86-013642710612, 123213197@qq.com
Jin Yuan, M.D., Ph.D.
About this study
Official title: To Evaluate the Efficacy of 3% Diquafosol Sodium in the Treatment of Mild to Moderate MGD in Different Treatment Pattern
MGD is a chronic, diffuse abnormality of the meibomian glands, commonly characterized by terminal duct obstruction and/or qualitative/quantitative changes in the glandular secretion. It may result in alteration of the tear film, symptoms of eye irritation, clinically apparent inflammation, and ocular surface disease. The meibomian glands, found in the upper and lower eyelids, excrete lipids onto the ocular surface that forms the outermost layer of the tear film, lubricating the ocular surface during blinking and protecting against tear evaporation.1 2 Through dysfunction of the meibomian glands, reduced lipid secretion may contribute to tear film instability and entry into the vicious circle of dry eye disease. The prevalence of MGD is higher in Asian populations, ranging from 46% to 70%.
The management and treatment subcommittee of the International Workshop on MGD proposed a treatment algorithm in which treatment is added depending on the severity of MGD. The sequence of treatment addition is eyelid hygiene, eyelid warming and massage, artificial lubricants, topical azithromycin, topical emollient lubricant, oral tetracycline derivatives, lubricant ointment, and anti-inflammatory therapy.
Topical diquafosol solution has been used to treat dry eye because it increases fluid secretion from conjunctival epithelial cells and mucin secretion from conjunctival goblet cells via the P2Y2 receptor. Because P2Y2 receptor expression is observed in sebaceous cells and ductal cells in the meibomian gland, diquafosol is expected to have some effects on meibomian glands. it has been reported that use 3% diquafosol ophthalmic solution in patients with obstructive MGD for more than 4 months. Ocular symptoms, lid margin abnormalities, the superficial punctate keratopathy score, and the meibum grade were decreased, while the tear breakup time, tear film meniscus area, and meibomian gland area were increased. These results suggest that topical diquafosol therapy is effective for patients with obstructive MGD. However, so far, no studies have reported the effect of DQS combined with eyelid hot compress and eyelid gland massage for MGD.
- Conditions
- Dry Eye, Meibomian Gland Dysfunction
- Being tested
- Warm compresses, 3% Diquafosol Sodium Eye Drops
- Medical subject headings
- Dry Eye Syndromes, Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warm compressesProcedure or surgery
Commercial eye patch, 10 min before lid massage.Warm compresses and lid massage every 2 weeks，5 times in total（0，2, 4, 6, 8W）.
3% Diquafosol Sodium Eye DropsDrug
3% Diquafosol Sodium Eye Drops (DIQUAS ophthalmic solution 3%; Santen Pharmaceutical Co. Ltd, Osaka, Japan)，3% diquafosol was administered six times a day for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group I:3% diquafosol | Experimental | 70 people, 70 eyes. Receives: Drug: 3% Diquafosol Sodium Eye Drops |
| Group II:3% diquafosol and warm compresses and lid massage | Other | 70 people, 70 eyes. Receives: Procedure: Warm compresses; Drug: 3% Diquafosol Sodium Eye Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
The tear fluorescein break-up time changes at 12 weeks from baseline in both groups.
The standard TBUT measurement was performed. After 1%fluorescein dye was instilled into the conjunctival sac, the interval between the last complete blink and the appearance of the first corneal black spot in the stained tear film was measured three times and the mean value of the measurements was calculated.
Measured: 12 weeks
Secondary outcomes (13)
The tear fluorescein break-up time changes at 2 and 4 weeks from baseline in both groups.
The standard TBUT measurement was performed. After 1%fluorescein dye was instilled into the conjunctival sac, the interval between the last complete blink and the appearance of the first corneal black spot in the stained tear film was measured three times and the mean value of the measurements was calculated.
Measured: 2,4 weeks
The CFS changes at 2 ，4 and 12 weeks from baseline in both groups.
Measured: 2,4 and 12 weeks
The OSDI changes at 2 ，4 and 12 weeks from baseline in both groups.
The dry eye diagnosis flowchart begins with history-taking, risk factors are questioned in suspicious cases, and a screening test such as the Ocular Surface Disease Index (OSDI) Questionnaire is applied.
Measured: 2,4 and 12 weeks
The lid margin hyperaemia changes at 2 ，4 and 12 weeks from baseline in both groups
lid margin hyperaemia：score=0: no or slightly congested conjunctiva at the eyelid margin, no telangiectasis at the opening of the meibomian gland; score=1: conjunctival congestion at the edge of the eyelid, no telangiectasis at the opening of the meibomian gland; score=2: conjunctival congestion at the edge of the eyelid, telangiectasis at the opening of the meibomian gland, and the scope <1/2 eyelid margin; score=3: conjunctival hyperemia at the eyelid margin, telangiectasis at the opening of the meibomian gland, and the range is 1/2 of the eyelid margin.
Measured: 2,4 and 12 weeks
The LLT changes at 2 ，4 and 12 weeks from baseline in both groups.
LLT:LipiView eye surface interferometer The optical interferometry images of the tear film lipid layer are obtained, and the LLT values are automatically obtained according to the color of the images, and the expression of the optical interferometric color units (ICU). 1 ICU stand for 1 nm LLT. LLT is less than or equal to 60nm, and MGD is 90% probable. The device also can record the number of blinks and the proportion of incomplete blinks.
Measured: 2,4 and 12 weeks
The TMH changes at 2 ，4 and 12 weeks from baseline in both groups.
TMH:measured by tear film pattern of Keratograph 5M (Oculus, Wetzlar, Germany) before other invasive procedures. In the tear meniscus measure section of TF pattern, manually measure the tear meniscus height along the middle of lower eyelid with the ruler option after image.
Measured: 2,4 and 12 weeks
The meiboscore (meibomian gland drop out score) changes at 2 ，4 and 12 weeks from baseline in both groups.
The meibomian glands drop out score(Meiboscore): meiboscore=0: without meibomian gland loss on visual inspection of images. meiboscore=1: with meibomian gland area loss of less than one-third of the total area. meiboscore=2: with meibomian gland area loss between one-third and two-thirds of the total area. meiboscore=3: with meibomian gland area loss of more than two-thirds of the total area. Evaluate the upper eyelid and record the score.
Measured: 2,4 and 12 weeks
The changes of multi-measurement of Meibomian glands by meibography at 4 and 12 weeks from baseline in both groups
Measured: 4 and 12 weeks
The changes of corneal sensitivity at 2, 4 and 12 weeks from baseline in both groups.
Cornea sensitivity：Cochet-Bonnet: The gold standard for assessing corneal perception. During the perceptual examination, the patient was asked to look forward and the perceptual apparatus acted vertically on the corneal plane. In general, the higher the number recorded, the more sensitive the cornea. Its measurement should be made before other measurements, especially before topical anesthesia is applied, and the results are more reliable. use Cochet-Bonnet to detect the sensitivity of 5 areas of cornea, the up and down of nasal side, central cornea, the up and down of temporal side.
Measured: 2,4 and 12 weeks
The correlation between the change trend of meiboscore (meibomian gland drop our score)、meibomian glands opening score、meibum expressibility score、meibum quality score、LLT、corneal sensitivity and FBUT、CFS、OSDI.
Measured: 12 weeks
meibomian glands opening score changes at 2 ，4 and 12 weeks from baseline in both groups.
Measured: 2,4 and 12 weeks
meibum quality score changes at 2 ，4 and 12 weeks from baseline in both groups.
Measured: 2,4 and 12 weeks
meibum expressibility score changes at 2 ，4 and 12 weeks from baseline in both groups.
Measured: 2,4 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start5 Aug 2022
- Primary completion20 May 2024 (estimated)
- Study completion20 May 2025 (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
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Yuan, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05383612
- Sponsor's protocol ID
- 2022KYPJ085
- Status last verified
- Feb 2023
- First submitted
- 13 Apr 2022
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Efficacy of 3% Diquafosol Sodium in the Treatment of Mild to Moderate MGD in Different Treatment Pattern
- ClinicalTrials.gov ID
- NCT05383612
- Acronym / sponsor ID
- 2022KYPJ085
- Conditions
- Dry Eye, Meibomian Gland Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 5 Aug 2022 (actual)
- Primary completion
- 20 May 2024 (estimated)
- Study completion
- 20 May 2025 (estimated)
- First posted
- 20 May 2022 (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.
MGD is a chronic, diffuse abnormality of the meibomian glands, commonly characterized by terminal duct obstruction and/or qualitative/quantitative changes in the glandular secretion. It may result in alteration of the tear film, symptoms of eye irritation, clinically apparent inflammation, and ocular surface disease. The meibomian glands, found in the upper and lower eyelids, excrete lipids onto the ocular surface that forms the outermost layer of the tear film, lubricating the ocular surface during blinking and protecting against tear evaporation.1 2 Through dysfunction of the meibomian glands, reduced lipid secretion may contribute to tear film instability and entry into the vicious circle of dry eye disease. The prevalence of MGD is higher in Asian populations, ranging from 46% to 70%.
The management and treatment subcommittee of the International Workshop on MGD proposed a treatment algorithm in which treatment is added depending on the severity of MGD. The sequence of treatment addition is eyelid hygiene, eyelid warming and massage, artificial lubricants, topical azithromycin, topical emollient lubricant, oral tetracycline derivatives, lubricant ointment, and anti-inflammatory therapy.
Topical diquafosol solution has been used to treat dry eye because it increases fluid secretion from conjunctival epithelial cells and mucin secretion from conjunctival goblet cells via the P2Y2 receptor. Because P2Y2 receptor expression is observed in sebaceous cells and ductal cells in the meibomian gland, diquafosol is expected to have some effects on meibomian glands. it has been reported that use 3% diquafosol ophthalmic solution in patients with obstructive MGD for more than 4 months. Ocular symptoms, lid margin abnormalities, the superficial punctate keratopathy score, and the meibum grade were decreased, while the tear breakup time, tear film meniscus area, and meibomian gland area were increased. These results suggest that topical diquafosol therapy is effective for patients with obstructive MGD. However, so far, no studies have reported the effect of DQS combined with eyelid hot compress and eyelid gland massage for MGD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I:3% diquafosol | Experimental | Drug: 3% Diquafosol Sodium Eye Drops70 people, 70 eyes. |
| Group II:3% diquafosol and warm compresses and lid massage | Other | Procedure: Warm compresses, Drug: 3% Diquafosol Sodium Eye Drops70 people, 70 eyes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with FBUT<10s；
- Presence of ocular symptoms with OSDI score≥13；
- 0<The score of meibum quality or expressibility ≤2；
- 1/3≤The meibomian drop-out ≤2/3 (meiboscore ≤2)
Key exclusion criteria (9 listed)
- patients diagnosed of dry eye with Sjogren syndrome or diabetic mellitus.
- Patients who wear contact lens during study or accepted refractive surgery within 6 months before screening.
- Patients who have allergy history or adverse reactions to the experimental drugs or its components.
- Patients with active ocular inflammation such as infectious keratitis or blepharitis.
- Patients who had received ocular or system steroids or immunosuppressant 2 weeks before screening.
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 |
|---|---|---|
| Warm compressesCommercial eye patch, 10 min before lid massage.Warm compresses and lid massage every 2 weeks，5 times in total（0，2, 4, 6, 8W）. | Procedure or surgery | Group II:3% diquafosol and warm compresses and lid massage |
| 3% Diquafosol Sodium Eye Drops3% Diquafosol Sodium Eye Drops (DIQUAS ophthalmic solution 3%; Santen Pharmaceutical Co. Ltd, Osaka, Japan)，3% diquafosol was administered six times a day for 12 weeks. | Drug | Group I:3% diquafosol, Group II:3% diquafosol and warm compresses and lid massage |
Primary outcome
The tear fluorescein break-up time changes at 12 weeks from baseline in both groups.
Time frame: 12 weeks
The standard TBUT measurement was performed. After 1%fluorescein dye was instilled into the conjunctival sac, the interval between the last complete blink and the appearance of the first corneal black spot in the stained tear film was measured three times and the mean value of the measurements was calculated.
13 secondary outcomes
The tear fluorescein break-up time changes at 2 and 4 weeks from baseline in both groups.
Time frame: 2,4 weeks
The CFS changes at 2 ，4 and 12 weeks from baseline in both groups.
Time frame: 2,4 and 12 weeks
The OSDI changes at 2 ，4 and 12 weeks from baseline in both groups.
Time frame: 2,4 and 12 weeks
The lid margin hyperaemia changes at 2 ，4 and 12 weeks from baseline in both groups
Time frame: 2,4 and 12 weeks
The LLT changes at 2 ，4 and 12 weeks from baseline in both groups.
Time frame: 2,4 and 12 weeks
The TMH changes at 2 ，4 and 12 weeks from baseline in both groups.
Time frame: 2,4 and 12 weeks
The meiboscore (meibomian gland drop out score) changes at 2 ，4 and 12 weeks from baseline in both groups.
Time frame: 2,4 and 12 weeks
The changes of multi-measurement of Meibomian glands by meibography at 4 and 12 weeks from baseline in both groups
Time frame: 4 and 12 weeks
The changes of corneal sensitivity at 2, 4 and 12 weeks from baseline in both groups.
Time frame: 2,4 and 12 weeks
The correlation between the change trend of meiboscore (meibomian gland drop our score)、meibomian glands opening score、meibum expressibility score、meibum quality score、LLT、corneal sensitivity and FBUT、CFS、OSDI.
Time frame: 12 weeks
meibomian glands opening score changes at 2 ，4 and 12 weeks from baseline in both groups.
Time frame: 2,4 and 12 weeks
meibum quality score changes at 2 ，4 and 12 weeks from baseline in both groups.
Time frame: 2,4 and 12 weeks
meibum expressibility score changes at 2 ，4 and 12 weeks from baseline in both groups.
Time frame: 2,4 and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Warm compresses and 3% Diquafosol Sodium Eye Drops in people with Dry Eye and Meibomian Gland Dysfunction, 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 4 inclusion and 9 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 21 Feb 2023. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The tear fluorescein break-up time changes at 12 weeks from baseline in both groups. (time frame: 12 weeks). 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 21 Feb 2023.