NCT02595606

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2015

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 3, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

January 12, 2016

Status Verified

January 1, 2016

Enrollment Period

6 months

First QC Date

October 30, 2015

Last Update Submit

January 11, 2016

Conditions

Dry Eye SyndromesDiabetes Mellitus

Keywords

dry eye syndromesdiabetes mellitus

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • tear break up time

    up to 2 months

  • Schirmer' test

    up to 2 months

  • conjunctival goblet cells density

    up to 2 months

  • corneal fluorescein staining assessment

    up to 2 months

Study Arms (2)

treatment group

EXPERIMENTAL

treatment with 0.3% Sodium Hyaluronate, by five times a day, one or two drop each time

Drug: 0.3% Sodium Hyaluronate

control group

NO INTERVENTION

without treatment

Interventions

0.3% Sodium HyaluronateDRUG

five times per day for the intervention of eye drop

treatment group

Eligibility Criteria

Age17 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Center

Guangzhou, Guangdong, 510000, China

RECRUITING

Related Publications (6)

  • 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.

    PMID: 11004112BACKGROUND

  • 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.

    PMID: 8776562BACKGROUND

  • 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.

    PMID: 21215678BACKGROUND

  • 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.

    PMID: 17392158BACKGROUND

  • 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.

    PMID: 21924232BACKGROUND

  • 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.

    PMID: 16331044BACKGROUND

MeSH Terms

Conditions

Dry Eye SyndromesDiabetes Mellitus

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Central Study Contacts

Zhang Xiulan, M.D.

CONTACT

02087335367zhangxl2@mail.sysu.edu.cn

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
cornea department chief

Study Record Dates

First Submitted

October 30, 2015

First Posted

November 3, 2015

Study Start

September 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

January 12, 2016

Record last verified: 2016-01

Locations

CN(1)