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

January 2, 2014 updated by: Xiangtian Zhou, Wenzhou Medical University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325027
        • Eye Hospital, Wenzhou Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: group 1
Drug: nonsteroid anti-inflammatory drops
nonsteroid anti-inflammatory drops plus artificial tear substitute
Other Names:
  • bronuck
EXPERIMENTAL: group 2
Drug: nonsteroid anti-inflammatory drops
nonsteroid anti-inflammatory drops plus artificial tear substitute
Other Names:
  • bronuck
EXPERIMENTAL: group 3
Drug: corticosteroids
corticosteroids plus artificial tear substitute
Other Names:
  • Fluorometholone
OTHER: group 4
Drug: artificial tear substitute
artificial tear substitute alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
tear osmolarity
Time Frame: Day 0, Day 14
Day 0, Day 14

Secondary Outcome Measures

Outcome Measure
Time Frame
corneal staining
Time Frame: 0 day,7th day and 14th day after treatment
0 day,7th day and 14th day after treatment
Schirmer test(without anaesthesia)
Time Frame: 0 day,7th day,14th day after treatment
0 day,7th day,14th day after treatment
tear film breakup time(TBUT)
Time Frame: 0 day,7th day and 14th day after treatment
0 day,7th day and 14th day after treatment
meibomian gland function
Time Frame: 0 day,7th day and 14th day after treatment
0 day,7th day and 14th day after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wenzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (ACTUAL)

June 1, 2012

Study Completion (ACTUAL)

July 1, 2012

Study Registration Dates

First Submitted

March 22, 2012

First Submitted That Met QC Criteria

March 23, 2012

First Posted (ESTIMATE)

March 26, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 3, 2014

Last Update Submitted That Met QC Criteria

January 2, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Xzhou

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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