NCT04980144

Diquafosol Ophthalmic Solution for Dry Eye Symptoms

Status unknown NA Last updated 12 January 2023

What this trial tests

NA trial testing 3% Diquafosol tetrasodium in Diabetic Eye Problems in 101 participants. Status unknown.

Timeline

3 March 2023

Primary endpoint
31 August 2023

1 November 2023

Quick facts

Lead sponsor	He Eye Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	supportive care
Enrollment	101
Start date	3 March 2023
Primary completion	31 August 2023
Estimated completion	1 November 2023
Sites	1 location across China

Drugs / interventions tested

• 3% Diquafosol tetrasodium — full drug profile →
• 0.1% hyaluronate — full drug profile →

Conditions studied

• Diabetic Eye Problems — all drugs for Diabetic Eye Problems →

Sponsor

He Eye Hospital

Who can join

Adults 18 to 99, any sex, with Diabetic Eye Problems. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Impact of Diquafosol Ophthalmic Solution on Tear Film and Dry Eye Symptom in Type 2 Diabetic Dry Eye: A Pilot Study.
   Zhang Q, Zhang H, Qin G, Wu Y, et al · · 2022 · cited 24× · PMID 35049373 · DOI 10.1089/jop.2021.0083
2. A protocol for a single center, randomized, controlled trial comparing the clinical efficacy of 3% diquafosol and 0.1 % hyaluronic acid in diabetic patients with dry eye disease.
   Chen J, Chen Y, Li L, Qin G, et al · · 2023 · DOI 10.21203/rs.3.rs-2365092/v1