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

This study is currently recruiting participants.

Verified March 2012 by Wenzhou Medical College

Sponsor:

Information provided by:

Wenzhou Medical College

ClinicalTrials.gov Identifier:

NCT01562795

First received: March 22, 2012

Last updated: March 23, 2012

Last verified: March 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

March 22, 2012

Last Updated Date

March 23, 2012

Start Date ^ICMJE

March 2012

Estimated Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

tear osmolarity [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01562795 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Moderate to Severe Dry Eye Disease

Intervention ^ICMJE

Drug: nonsteroid anti-inflammatory drops plus artificial tear substitute
Other Name: prunoprefen
Drug: nonsteroid anti-inflammatory drops plus artificial tear substitute
Other Name: bronuck
Drug: corticosteroids plus artificial tear substitute
Other Name: Fluorometholone
Drug: artificial tear substitute

Study Arm (s)

Experimental: group 1
Intervention: Drug: nonsteroid anti-inflammatory drops plus artificial tear substitute
Experimental: group 2
Intervention: Drug: nonsteroid anti-inflammatory drops plus artificial tear substitute
Experimental: group 3
Intervention: Drug: corticosteroids plus artificial tear substitute
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

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2012

Estimated 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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Wei Chen, MD，PhD

8613757728118

chenweimd@hotmail.com

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT01562795

Other Study ID Numbers ^ICMJE

Xzhou

Has Data Monitoring Committee

Yes

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Wenzhou Medical College

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Wei Chen, MD,PhD

Eye Hospital, Wenzhou Medical College, China

Information Provided By

Wenzhou Medical College

Verification Date

March 2012

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

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