0.3% Sodium Hyaluronate in the Treatment of Dry Eye of Diabetic Patients

Phase 4

• Conditions: Dry Eye Syndromes; Diabetes Mellitus
• Interventions: Drug: 0.3% Sodium Hyaluronate

• Registration Number: NCT02595606
• Lead Sponsor: Sun Yat-sen University

Brief Summary

A randomized parallel controlled study was designed to compare the efficacy of 0.3% Sodium Hyaluronate in the treatment of Dry Eye of diabetic patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-10-30
• Study First Submitted QC: 2015-11-02
• Study First Posted: 2015-11-03
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-11
• Last Update Posted: 2016-01-12
• Primary Completion: 2016-03
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. medical history of diabetes
2. diagnosed with proliferative diabetic retinopathy
3. diagnosed with dry eye
4. not involvement in other drug experiment in the past 2 weeks
5. vision acuity better than 0.1
6. no local drug using history or with at least 2 weeks blanking period

Exclusion Criteria

1. allergy to any of the drug ingredient
2. being or going to be pregnant or in lactation period
3. with any other eye disease or other serious disease which might affect the trial or could not get in follow-up
4. with any eye surgery history in the past six months
5. usage of hormone for replacement therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
treatment group	0.3% Sodium Hyaluronate	treatment with 0.3% Sodium Hyaluronate, by five times a day, one or two drop each time

Primary Outcome Measures

Name	Time	Method
ocular surface disease index	up to 2 months	pre-,1,4,8 weeks after the initiation of the study(the use of drug for experimental group)

Secondary Outcome Measures

Name	Time	Method
tear break up time	up to 2 months	BUT
corneal fluorescein staining assessment	up to 2 months	assessment of the corneal invasion
Schirmer' test	up to 2 months	test of tear secretion
conjunctival goblet cells density	up to 2 months	indirect assessment of tear quality

Trial Locations

Locations (1)

Clinical Research Center; 🇨🇳 Guangzhou, Guangdong, China