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Diquafosol Ophthalmic Solution for Dry Eye Symptoms

NCT04980144 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2023-01-12

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. 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.

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

DRUG

0.1% hyaluronate

0.1% hyaluronate eye drops will be used to assess its usefulness in diabetic dry eye symptoms and compared to 3% Diquafosol tetrasodium eye drops.

Sponsors & Collaborators

  • He Eye Hospital

    lead OTHER

Principal Investigators

  • Emmanuel Eric Pazo · He Eye Hospital, Shenyang, China

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-03-03
Primary Completion
2023-08-31
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 NCT04980144 on ClinicalTrials.gov