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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xiangtian Zhou, Wenzhou Medical University
ClinicalTrials.gov Identifier:
NCT01562795
First received: March 22, 2012
Last updated: January 2, 2014
Last verified: January 2014

March 22, 2012
January 2, 2014
March 2012
June 2012   (final data collection date for primary outcome measure)
tear osmolarity [ Time Frame: Day 0, Day 14 ] [ Designated as safety issue: No ]
tear osmolarity [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01562795 on ClinicalTrials.gov Archive Site
  • corneal staining [ Time Frame: 0 day,7th day and 14th day after treatment ] [ Designated as safety issue: Yes ]
  • Schirmer test(without anaesthesia) [ Time Frame: 0 day,7th day,14th day after treatment ] [ Designated as safety issue: No ]
  • tear film breakup time(TBUT) [ Time Frame: 0 day,7th day and 14th day after treatment ] [ Designated as safety issue: No ]
  • meibomian gland function [ Time Frame: 0 day,7th day and 14th day after treatment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy of Nonsteroidal Anti-inflammatory Drugs in Treatment of Moderate and Severe Dry Eye Disease
Efficacy of Nonsteroidal Anti-inflammatory Drugs in Treatment of Moderate and Severe Dry Eye Disease

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Moderate to Severe Dry Eye Syndrome
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
July 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01562795
Xzhou
Yes
Xiangtian Zhou, Wenzhou Medical University
Wenzhou Medical University
Not Provided
Principal Investigator: Wei Chen, MD,PhD Eye Hospital, Wenzhou Medical College, China
Wenzhou Medical University
January 2014

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