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Efficacy of Nonsteroidal Anti-inflammatory Drugs in Treatment of Moderate and Severe Dry Eye Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01562795
Recruitment Status : Completed
First Posted : March 26, 2012
Last Update Posted : January 3, 2014
Sponsor:
Information provided by (Responsible Party):
Xiangtian Zhou, Wenzhou Medical University

Tracking Information
First Submitted Date  ICMJE March 22, 2012
First Posted Date  ICMJE March 26, 2012
Last Update Posted Date January 3, 2014
Study Start Date  ICMJE March 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 2, 2014)
tear osmolarity [ Time Frame: Day 0, Day 14 ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 23, 2012)
tear osmolarity
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2012)
  • corneal staining [ Time Frame: 0 day,7th day and 14th day after treatment ]
  • Schirmer test(without anaesthesia) [ Time Frame: 0 day,7th day,14th day after treatment ]
  • tear film breakup time(TBUT) [ Time Frame: 0 day,7th day and 14th day after treatment ]
  • meibomian gland function [ Time Frame: 0 day,7th day and 14th day after treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Nonsteroidal Anti-inflammatory Drugs in Treatment of Moderate and Severe Dry Eye Disease
Official Title  ICMJE Efficacy of Nonsteroidal Anti-inflammatory Drugs in Treatment of Moderate and Severe Dry Eye Disease
Brief Summary This clinical trial is to investigate whether nonsteroid anti-inflammatory drops have therapeutic effect on moderate to severe dry eye patients.And compare the efficacy of the two nonsteroid anti-inflammatory drops with topical corticosteroids.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Moderate to Severe Dry Eye Syndrome
Intervention  ICMJE
  • Drug: nonsteroid anti-inflammatory drops
    nonsteroid anti-inflammatory drops plus artificial tear substitute
    Other Name: prunoprefen
  • Drug: nonsteroid anti-inflammatory drops
    nonsteroid anti-inflammatory drops plus artificial tear substitute
    Other Name: bronuck
  • Drug: corticosteroids
    corticosteroids plus artificial tear substitute
    Other Name: Fluorometholone
  • Drug: artificial tear substitute
    artificial tear substitute alone
Study Arms  ICMJE
  • Experimental: group 1
    Intervention: Drug: nonsteroid anti-inflammatory drops
  • Experimental: group 2
    Intervention: Drug: nonsteroid anti-inflammatory drops
  • Experimental: group 3
    Intervention: Drug: corticosteroids
  • group 4
    Intervention: Drug: artificial tear substitute
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 23, 2012)
48
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • moderate to severe dry eye syndrome
  • tear film breakup time >0 second and ≤5 seconds,or schirmer test(no anaesthesia)≥2mm/5min and ≤5mm/5min
  • corneal staining≥3 scores

Exclusion Criteria:

  • allergic to any composition of the drugs under experiment
  • previous use of anti-inflammatory drugs or immunosuppressive agent
  • viral,bacterial or fungal infection of the eye
  • eyelid anomaly
  • glaucoma or high IOP
  • significant meibomian gland dysfunction
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01562795
Other Study ID Numbers  ICMJE Xzhou
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Xiangtian Zhou, Wenzhou Medical University
Study Sponsor  ICMJE Wenzhou Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Wei Chen, MD,PhD Eye Hospital, Wenzhou Medical College, China
PRS Account Wenzhou Medical University
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP