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NCT05682547
Diquafosol vs Hyaluronic Acid for Diabetic Dry Eye
Conditions: Diabetic Eye Problems
Sex: All
Ages: 18 Years – 99 Years
Phase: NA
Enrollment: 202
Sponsor: He Eye Hospital
Location: China
Summary
Diquafosol ophthalmic solution (DQS) stimulates P2Y2 receptors on the ocular surface, which enhances mucin secretion from goblet cells.
Therefore, tear film stability and hydration of the ocular surface can be achieved independent from lacrimal glands function.
While it has been observed that 0.1 percent hyaluronate (HA) in artificial tears promotes corneal re-epithelium and improves corneal healing.This prospective, open label pilot study will include 60 eyes of 30 diabetic patients diagnosed with DED and will be randomly assigned to either DQS (n=30 eyes) or ATD group (n=30 eyes).
Participants in the DQS group will receive 3% Diquafosol ophthalmic solution, while HA group will receive 0.1% Sodium hyaluronate artificial tears.
The dosage for both drugs will be one drop, six times per day for 4 weeks.
Tear film lipid layer (TFLL), non-invasive breakup time (NITBUT), corneoconjunctival staining score (CS), meibum gland (MG), conjunctival hyperemia (RS score), ocular surface disease index (OSDI) will be assessed and compared at baseline, day-14, and day-28.
Eligibility Criteria
Inclusion Criteria:Age ≥18 yearsClinical diagnosed and confirmed with type 2 diabetes for one year or moreAble and willing to comply with the treatment/follow-up scheduleBilateral signs and symptoms of dry eye diseaseExclusion Criteria:Participants with systemic immune-mediated illnesses, such as secondary Sjögren's syndrome or graft-versus-host diseasePatients using topical medication(s) for the treatment of ocular disorders such as glaucoma or allergic conjunctivitis were excluded from the study.Previous ocular surgery or trauma1-month history of blepharal and periorbital skin disease or allergiesSevere dry eyes with corneal epithelial defectLimbic keratitisPterygiumCorneal neovascularizationGlaucomaBreastfeedingRheumatic immune systemic diseasesHerpes zoster infectionPregnant womenAllergic to fluoresceinContact lens wearers
Source: ClinicalTrials.gov (NCT05682547). StuddyBuddy aggregates publicly available trial information.