Clinical trial NCT05383612: To Evaluate the Efficacy of Diquafosol Sodium in the Treatment of MGD in Different Treatment Pattern
Official title: To Evaluate the Efficacy of 3% Diquafosol Sodium in the Treatment of Mild to Moderate MGD in Different Treatment Pattern
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dry Eye
Meibomian Gland Dysfunction
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-05-20
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

1. Patients with FBUT\<10s；
2. Presence of ocular symptoms with OSDI score≥13；
3. 0\<The score of meibum quality or expressibility ≤2；
4. 1/3≤The meibomian drop-out ≤2/3 (meiboscore ≤2)

Exclusion Criteria:

1. patients diagnosed of dry eye with Sjogren syndrome or diabetic mellitus.
2. Patients who wear contact lens during study or accepted refractive surgery within 6 months before screening.
3. Patients who have allergy history or adverse reactions to the experimental drugs or its components.
4. Patients with active ocular inflammation such as infectious keratitis or blepharitis.
5. Patients who had received ocular or system steroids or immunosuppressant 2 weeks before screening.
6. Patients who had received any other experimental drug 2 weeks before screening.
7. Patients with concomitant disease who were considered unable to evaluate efficacy or unlikely to complete the expected course of treatment and follow-up.
8. Pregnant and lactating women, or those planning a pregnancy over the course of the study.
9. Patients judged by the investigator to be unsuitable for the study.

Primary outcomes:
measure: The tear fluorescein break-up time changes at 12 weeks from baseline in both groups.
timeFrame: 12 weeks
Secondary outcomes:
measure: The tear fluorescein break-up time changes at 2 and 4 weeks from baseline in both groups.
timeFrame: 2,4 weeks
measure: The CFS changes at 2 ，4 and 12 weeks from baseline in both groups.
timeFrame: 2,4 and 12 weeks
measure: The OSDI changes at 2 ，4 and 12 weeks from baseline in both groups.
timeFrame: 2,4 and 12 weeks
measure: The lid margin hyperaemia changes at 2 ，4 and 12 weeks from baseline in both groups
timeFrame: 2,4 and 12 weeks
measure: The LLT changes at 2 ，4 and 12 weeks from baseline in both groups.
timeFrame: 2,4 and 12 weeks
measure: The TMH changes at 2 ，4 and 12 weeks from baseline in both groups.
timeFrame: 2,4 and 12 weeks
measure: The meiboscore (meibomian gland drop out score) changes at 2 ，4 and 12 weeks from baseline in both groups.
timeFrame: 2,4 and 12 weeks
measure: The changes of multi-measurement of Meibomian glands by meibography at 4 and 12 weeks from baseline in both groups
timeFrame: 4 and 12 weeks
measure: The changes of corneal sensitivity at 2, 4 and 12 weeks from baseline in both groups.
timeFrame: 2,4 and 12 weeks
measure: 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.
timeFrame: 12 weeks
measure: meibomian glands opening score changes at 2 ，4 and 12 weeks from baseline in both groups.
timeFrame: 2,4 and 12 weeks
measure: meibum quality score changes at 2 ，4 and 12 weeks from baseline in both groups.
timeFrame: 2,4 and 12 weeks
measure: meibum expressibility score changes at 2 ，4 and 12 weeks from baseline in both groups.
timeFrame: 2,4 and 12 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-Sen University
state: Guangdong
Study officials:
References: