Clinical trial NCT02595606: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Dry Eye Syndromes
Diabetes Mellitus
Keywords: dry eye syndromes
diabetes mellitus
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2015-11-03
Enrollment: 60
Sex: ALL
Minimum age (years): 17
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: ocular surface disease index
timeFrame: up to 2 months
Secondary outcomes:
measure: tear break up time
timeFrame: up to 2 months
measure: Schirmer' test
timeFrame: up to 2 months
measure: conjunctival goblet cells density
timeFrame: up to 2 months
measure: corneal fluorescein staining assessment
timeFrame: up to 2 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Clinical Research Center
state: Guangdong
Study officials:
References:
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.
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.
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.
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.
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.
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.