To Evaluate the Efficacy of Diquafosol Sodium in the Treatment of MGD in Different Treatment Pattern

NCT05383612 | Unknown

• 1 other identifier: 2022KYPJ085
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye; Meibomian Gland Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (13)

• The tear fluorescein break-up time changes at 2 and 4 weeks from baseline in both groups.

  2,4 weeks

• The CFS changes at 2 ，4 and 12 weeks from baseline in both groups.

  2,4 and 12 weeks

• The OSDI changes at 2 ，4 and 12 weeks from baseline in both groups.

  2,4 and 12 weeks

• The lid margin hyperaemia changes at 2 ，4 and 12 weeks from baseline in both groups

  2,4 and 12 weeks

• The LLT changes at 2 ，4 and 12 weeks from baseline in both groups.

  2,4 and 12 weeks

Study Arms (2)

Group I:3% diquafosol

EXPERIMENTAL

70 people, 70 eyes.

Drug: 3% Diquafosol Sodium Eye Drops

Group II:3% diquafosol and warm compresses and lid massage

OTHER

70 people, 70 eyes.

Procedure: Warm compresses; Drug: 3% Diquafosol Sodium Eye Drops

Interventions

Warm compresses PROCEDURE

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）.

Group II:3% diquafosol and warm compresses and lid massage

3% Diquafosol Sodium Eye Drops DRUG

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.

Group I:3% diquafosol; Group II:3% diquafosol and warm compresses and lid massage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-Sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes; Meibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Eyelid Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: May 20, 2022
• Study Start: August 5, 2022
• Primary Completion: May 20, 2024
• Study Completion: May 20, 2025
• Last Updated: February 21, 2023

Record last verified: 2023-02

Locations

CN (1)