Back to results0.3% Sodium Hyaluronate in the Treatment of Dry Eye of Diabetic Patients
Primary Purpose
Dry Eye Syndromes, Diabetes Mellitus
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
0.3% Sodium Hyaluronate
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Syndromes focused on measuring dry eye syndromes, diabetes mellitus
Eligibility Criteria
Inclusion Criteria:
- medical history of diabetes
- diagnosed with proliferative diabetic retinopathy
- diagnosed with dry eye
- not involvement in other drug experiment in the past 2 weeks
- vision acuity better than 0.1
- no local drug using history or with at least 2 weeks blanking period
Exclusion Criteria:
- allergy to any of the drug ingredient
- being or going to be pregnant or in lactation period
- with any other eye disease or other serious disease which might affect the trial or could not get in follow-up
- with any eye surgery history in the past six months
- usage of hormone for replacement therapy
Sites / Locations
- Clinical Research CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
treatment group
control group
Arm Description
treatment with 0.3% Sodium Hyaluronate, by five times a day, one or two drop each time
without treatment
Outcomes
Primary Outcome Measures
ocular surface disease index
pre-,1,4,8 weeks after the initiation of the study(the use of drug for experimental group)
Secondary Outcome Measures
tear break up time
BUT
Schirmer' test
test of tear secretion
conjunctival goblet cells density
indirect assessment of tear quality
corneal fluorescein staining assessment
assessment of the corneal invasion
Full Information
NCT ID
NCT02595606
First Posted
October 30, 2015
Last Updated
January 11, 2016
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT02595606
Brief Title
0.3% Sodium Hyaluronate in the Treatment of Dry Eye of Diabetic Patients
Official Title
0.3% Sodium Hyaluronate in the Treatment of Dry Eye of Diabetic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
March 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes, Diabetes Mellitus
Keywords
dry eye syndromes, diabetes mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
treatment group
Arm Type
Experimental
Arm Description
treatment with 0.3% Sodium Hyaluronate, by five times a day, one or two drop each time
Arm Title
control group
Arm Type
No Intervention
Arm Description
without treatment
Intervention Type
Drug
Intervention Name(s)
0.3% Sodium Hyaluronate
Intervention Description
five times per day for the intervention of eye drop
Primary Outcome Measure Information:
Title
ocular surface disease index
Description
pre-,1,4,8 weeks after the initiation of the study(the use of drug for experimental group)
Time Frame
up to 2 months
Secondary Outcome Measure Information:
Title
tear break up time
Description
BUT
Time Frame
up to 2 months
Title
Schirmer' test
Description
test of tear secretion
Time Frame
up to 2 months
Title
conjunctival goblet cells density
Description
indirect assessment of tear quality
Time Frame
up to 2 months
Title
corneal fluorescein staining assessment
Description
assessment of the corneal invasion
Time Frame
up to 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
medical history of diabetes
diagnosed with proliferative diabetic retinopathy
diagnosed with dry eye
not involvement in other drug experiment in the past 2 weeks
vision acuity better than 0.1
no local drug using history or with at least 2 weeks blanking period
Exclusion Criteria:
allergy to any of the drug ingredient
being or going to be pregnant or in lactation period
with any other eye disease or other serious disease which might affect the trial or could not get in follow-up
with any eye surgery history in the past six months
usage of hormone for replacement therapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhang Xiulan, M.D.
Phone
02087335367
Email
zhangxl2@mail.sysu.edu.cn
Facility Information:
Facility Name
Clinical Research Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang Zhichong, M.D.
Phone
02087333391
Email
wzc001@hotmail.com
First Name & Middle Initial & Last Name & Degree
Gao Xinbo, M.D.
Phone
02087330484
Email
936319557@qq.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
11004112
Citation
Dogru M. Tear secretion and tear film function in insulin dependent diabetics. Br J Ophthalmol. 2000 Oct;84(10):1210. doi: 10.1136/bjo.84.10.1210. No abstract available.
Results Reference
background
PubMed Identifier
8776562
Citation
Fujishima H, Shimazaki J, Yagi Y, Tsubota K. Improvement of corneal sensation and tear dynamics in diabetic patients by oral aldose reductase inhibitor, ONO-2235: a preliminary study. Cornea. 1996 Jul;15(4):368-75. doi: 10.1097/00003226-199607000-00006.
Results Reference
background
PubMed Identifier
21215678
Citation
Zhivov A, Stachs O. Re: "Increased Langerhan cell density and corneal nerve damage in diabetic patients: Role of immune mechanisms in human diabetic neuropathy" by Tavakoli et al. Cont Lens Anterior Eye. 2011 Apr;34(2):98; author reply 99. doi: 10.1016/j.clae.2010.12.003. Epub 2011 Jan 6. No abstract available.
Results Reference
background
PubMed Identifier
17392158
Citation
Maruyama K, Asai J, Ii M, Thorne T, Losordo DW, D'Amore PA. Decreased macrophage number and activation lead to reduced lymphatic vessel formation and contribute to impaired diabetic wound healing. Am J Pathol. 2007 Apr;170(4):1178-91. doi: 10.2353/ajpath.2007.060018.
Results Reference
background
PubMed Identifier
21924232
Citation
Gao N, Yin J, Yoon GS, Mi QS, Yu FS. Dendritic cell-epithelium interplay is a determinant factor for corneal epithelial wound repair. Am J Pathol. 2011 Nov;179(5):2243-53. doi: 10.1016/j.ajpath.2011.07.050. Epub 2011 Sep 13.
Results Reference
background
PubMed Identifier
16331044
Citation
Lu W, Ebihara N, Miyazaki K, Murakami A. Reduced expression of laminin-5 in corneal epithelial cells under high glucose condition. Cornea. 2006 Jan;25(1):61-7. doi: 10.1097/01.ico.0000179932.21104.3c.
Results Reference
background
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0.3% Sodium Hyaluronate in the Treatment of Dry Eye of Diabetic Patients
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