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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02595606
• Other study ID #: 03SHDD
• Status: Recruiting
• Phase: Phase 4
• First received: October 30, 2015
• Last updated: January 11, 2016
• Start date: September 2015
• Est. completion date: March 2016

Study information

• Verified date: January 2016
• Source: Sun Yat-sen University
• Contact: Zhang Xiulan, M.D.
• Phone: 02087335367
• Email: zhangxl2[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Health authority: China:Zhongshan Ophthalmic Center, Sun Yat-sen University
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• 0.3% Sodium Hyaluronate
five times per day for the intervention of eye drop

Locations

Country	Name	City	State
China	Clinical Research Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (6)

Dogru M. Tear secretion and tear film function in insulin dependent diabetics. Br J Ophthalmol. 2000 Oct;84(10):1210. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ocular surface disease index	pre-,1,4,8 weeks after the initiation of the study(the use of drug for experimental group)	up to 2 months	No
Secondary	tear break up time	BUT	up to 2 months	No
Secondary	Schirmer' test	test of tear secretion	up to 2 months	No
Secondary	conjunctival goblet cells density	indirect assessment of tear quality	up to 2 months	No
Secondary	corneal fluorescein staining assessment	assessment of the corneal invasion	up to 2 months	No