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

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ClinicalTrials.gov Identifier: NCT02595606
Recruitment Status : Unknown
Verified January 2016 by Wang Zhichong, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : November 3, 2015
Last Update Posted : January 12, 2016
Sponsor:
Information provided by (Responsible Party):
Wang Zhichong, 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.

Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Diabetes Mellitus Drug: 0.3% Sodium Hyaluronate Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 0.3% Sodium Hyaluronate in the Treatment of Dry Eye of Diabetic Patients
Study Start Date : September 2015
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: treatment group
treatment with 0.3% Sodium Hyaluronate, by five times a day, one or two drop each time
Drug: 0.3% Sodium Hyaluronate
five times per day for the intervention of eye drop

No Intervention: control group
without treatment



Primary Outcome Measures :
  1. ocular surface disease index [ Time Frame: 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 :
  1. tear break up time [ Time Frame: up to 2 months ]
    BUT

  2. Schirmer' test [ Time Frame: up to 2 months ]
    test of tear secretion

  3. conjunctival goblet cells density [ Time Frame: up to 2 months ]
    indirect assessment of tear quality

  4. corneal fluorescein staining assessment [ Time Frame: up to 2 months ]
    assessment of the corneal invasion



Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02595606


Contacts
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Contact: Zhang Xiulan, M.D. 02087335367 zhangxl2@mail.sysu.edu.cn

Locations
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China, Guangdong
Clinical Research Center Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Wang Zhichong, M.D.    02087333391    wzc001@hotmail.com   
Contact: Gao Xinbo, M.D.    02087330484    936319557@qq.com   
Sponsors and Collaborators
Sun Yat-sen University

Publications:
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Responsible Party: Wang Zhichong, cornea department chief, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02595606     History of Changes
Other Study ID Numbers: 03SHDD
First Posted: November 3, 2015    Key Record Dates
Last Update Posted: January 12, 2016
Last Verified: January 2016

Keywords provided by Wang Zhichong, Sun Yat-sen University:
dry eye syndromes
diabetes mellitus

Additional relevant MeSH terms:
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Diabetes Mellitus
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents