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

NCT ID: NCT01562795

Last Updated: 2014-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-07-31

Brief Summary

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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

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Conditions

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Moderate to Severe Dry Eye Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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group 1

Group Type EXPERIMENTAL

nonsteroid anti-inflammatory drops

Intervention Type DRUG

nonsteroid anti-inflammatory drops plus artificial tear substitute

group 2

Group Type EXPERIMENTAL

nonsteroid anti-inflammatory drops

Intervention Type DRUG

nonsteroid anti-inflammatory drops plus artificial tear substitute

group 3

Group Type EXPERIMENTAL

corticosteroids

Intervention Type DRUG

corticosteroids plus artificial tear substitute

group 4

Group Type OTHER

artificial tear substitute

Intervention Type DRUG

artificial tear substitute alone

Interventions

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nonsteroid anti-inflammatory drops

nonsteroid anti-inflammatory drops plus artificial tear substitute

Intervention Type DRUG

nonsteroid anti-inflammatory drops

nonsteroid anti-inflammatory drops plus artificial tear substitute

Intervention Type DRUG

corticosteroids

corticosteroids plus artificial tear substitute

Intervention Type DRUG

artificial tear substitute

artificial tear substitute alone

Intervention Type DRUG

Other Intervention Names

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prunoprefen bronuck Fluorometholone

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wenzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Xiangtian Zhou

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wei Chen, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Eye Hospital, Wenzhou Medical College, China

Locations

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Eye Hospital, Wenzhou Medical College

Wenzhou, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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Xzhou

Identifier Type: -

Identifier Source: org_study_id

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