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Use of 3% Diquafosol Topical Ophthalmic Solution for Diabetic Dry Eye

NCT05193331 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2022-12-12

No results posted yet for this study

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. This prospective, open label pilot study will include 140 eyes of 70 diabetic patients diagnosed with DED and will be consecutively assigned to DQS (n=140 eyes). Participants in the DQS group will receive 3% Diquafosol ophthalmic solution. The dosage of 3% Diquafosol 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.

Conditions

  • Diabetic Eye Problems

Interventions

DRUG

3% Diquafosol tetrasodium

3% Diquafosol tetrasodium eye drops will be used to assess its usefulness in diabetic dry eye symptoms

Sponsors & Collaborators

  • Santen Pharmaceutical(China) Co.,LTD

    collaborator INDUSTRY

  • He Eye Hospital

    lead OTHER

Principal Investigators

  • Emmanuel E Pazo, PhD · He Eye Hospital, Shenyang, China

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2023-08-30
Completion
2023-11-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05193331 on ClinicalTrials.gov