Diquafosol Ophthalmic Solution for Dry Eye Symptoms

• Status: Completed
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: He Eye Hospital
• Treatments: Lubricant Eye Drops

Criteria

Inclusion Criteria:

• Age ≥18 years

• Clinical diagnosed and confirmed with type 2 diabetes for one year or more

• Able and willing to comply with the treatment/follow-up schedule

• Bilateral signs and symptoms of dry eye disease

Exclusion Criteria:

• Participants with systemic immune-mediated illnesses, such as secondary Sjögren's syndrome or graft-versus-host disease

• Patients 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 trauma

• 1-month history of blepharal and periorbital skin disease or allergies

• Severe dry eyes with corneal epithelial defect

• Limbic keratitis

• Pterygium

• Corneal neovascularization

• Glaucoma

• Breastfeeding

• Rheumatic immune systemic diseases

• Herpes zoster infection

• Pregnant women

• Allergic to fluorescein

• Contact lens wearers