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

Sun Yat-sen University

Status and phase: Unknown; Phase 4

Conditions: Diabetes Mellitus; Dry Eye Syndromes

Treatments: Drug: 0.3% Sodium Hyaluronate

Study type: Interventional

Funder types: Other

Identifiers

NCT02595606

03SHDD

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 17 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

treatment group

Experimental group

Description:

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

Treatment:

Drug: 0.3% Sodium Hyaluronate

control group

No Intervention group

Description:

without treatment