0.3% Sodium Hyaluronate in the Treatment of Dry Eye of Diabetic Patients
NCT ID: NCT02595606
Last Updated: 2016-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2015-09-30
2016-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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treatment group
treatment with 0.3% Sodium Hyaluronate, by five times a day, one or two drop each time
0.3% Sodium Hyaluronate
five times per day for the intervention of eye drop
control group
without treatment
No interventions assigned to this group
Interventions
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0.3% Sodium Hyaluronate
five times per day for the intervention of eye drop
Eligibility Criteria
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Inclusion Criteria
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
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
17 Years
70 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Wang Zhichong
cornea department chief
Locations
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Clinical Research Center
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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03SHDD
Identifier Type: -
Identifier Source: org_study_id
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