Status:
UNKNOWN
Use of 3% Diquafosol Topical Ophthalmic Solution for Diabetic Dry Eye
Lead Sponsor:
He Eye Hospital
Collaborating Sponsors:
Santen Pharmaceutical(China) Co.,LTD
Conditions:
Diabetic Eye Problems
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief 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 surfa...
Detailed Description
This study will be conducted in compliance with the tenets of the Declaration of Helsinki and the Institutional Review Board of He Eye Specialist Hospital, Shenyang, China \[ethics approval number: IR...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2023
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT05193331
Start Date
April 1 2023
End Date
November 1 2023
Last Update
December 12 2022
Active Locations (1)
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1
He Eye Hospital
Shenyang, Liaoning, China, 110001