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

Primary Purpose

Moderate to Severe Dry Eye Syndrome

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

nonsteroid anti-inflammatory drops

corticosteroids

artificial tear substitute

About this trial

This is an interventional treatment trial for Moderate to Severe Dry Eye Syndrome

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Eye Hospital, Wenzhou Medical College

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Other

Arm Label

group 1

group 2

group 3

group 4

Arm Description

Outcomes

Primary Outcome Measures

tear osmolarity

Secondary Outcome Measures

corneal staining

Schirmer test(without anaesthesia)

tear film breakup time(TBUT)

meibomian gland function

Full Information

NCT ID

NCT01562795

First Posted

March 22, 2012

Last Updated

January 2, 2014

Sponsor

Wenzhou Medical University

1. Study Identification

Unique Protocol Identification Number

NCT01562795

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

March 2012 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Wenzhou Medical University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Moderate to Severe Dry Eye Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

group 1

Arm Type

Experimental

Arm Title

group 2

Arm Type

Experimental

Arm Title

group 3

Arm Type

Experimental

Arm Title

group 4

Arm Type

Other

Intervention Type

Drug

Intervention Name(s)

nonsteroid anti-inflammatory drops

Other Intervention Name(s)

prunoprefen

Intervention Description

nonsteroid anti-inflammatory drops plus artificial tear substitute

Intervention Type

Drug

Intervention Name(s)

nonsteroid anti-inflammatory drops

Other Intervention Name(s)

bronuck

Intervention Description

nonsteroid anti-inflammatory drops plus artificial tear substitute

Intervention Type

Drug

Intervention Name(s)

corticosteroids

Other Intervention Name(s)

Fluorometholone

Intervention Description

corticosteroids plus artificial tear substitute

Intervention Type

Drug

Intervention Name(s)

artificial tear substitute

Intervention Description

artificial tear substitute alone

Primary Outcome Measure Information:

Title

tear osmolarity

Time Frame

Day 0, Day 14

Secondary Outcome Measure Information:

Title

corneal staining

Time Frame

0 day,7th day and 14th day after treatment

Title

Schirmer test(without anaesthesia)

Time Frame

0 day,7th day,14th day after treatment

Title

tear film breakup time(TBUT)

Time Frame

0 day,7th day and 14th day after treatment

Title

meibomian gland function

Time Frame

0 day,7th day and 14th day after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wei Chen, MD,PhD

Organizational Affiliation

Eye Hospital, Wenzhou Medical College, China

Official's Role

Principal Investigator

Facility Information:

Facility Name

Eye Hospital, Wenzhou Medical College

City

Wenzhou

State/Province

Zhejiang

ZIP/Postal Code

325027

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

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