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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01562795
First Posted: March 26, 2012
Last Update Posted: January 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Xiangtian Zhou, Wenzhou Medical University
  Purpose
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.

Condition Intervention
Moderate to Severe Dry Eye Syndrome Drug: nonsteroid anti-inflammatory drops Drug: corticosteroids Drug: artificial tear substitute

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Nonsteroidal Anti-inflammatory Drugs in Treatment of Moderate and Severe Dry Eye Disease

Resource links provided by NLM:


Further study details as provided by Xiangtian Zhou, Wenzhou Medical University:

Primary Outcome Measures:
  • tear osmolarity [ Time Frame: Day 0, Day 14 ]

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

Enrollment: 48
Study Start Date: March 2012
Study Completion Date: July 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: group 1 Drug: nonsteroid anti-inflammatory drops
nonsteroid anti-inflammatory drops plus artificial tear substitute
Other Name: prunoprefen
Experimental: group 2 Drug: nonsteroid anti-inflammatory drops
nonsteroid anti-inflammatory drops plus artificial tear substitute
Other Name: bronuck
Experimental: group 3 Drug: corticosteroids
corticosteroids plus artificial tear substitute
Other Name: Fluorometholone
group 4 Drug: artificial tear substitute
artificial tear substitute alone

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01562795


Locations
China, Zhejiang
Eye Hospital, Wenzhou Medical College
Wenzhou, Zhejiang, China, 325027
Sponsors and Collaborators
Wenzhou Medical University
Investigators
Principal Investigator: Wei Chen, MD,PhD Eye Hospital, Wenzhou Medical College, China
  More Information

Responsible Party: Xiangtian Zhou, MD, Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT01562795     History of Changes
Other Study ID Numbers: Xzhou
First Submitted: March 22, 2012
First Posted: March 26, 2012
Last Update Posted: January 3, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Anti-Inflammatory Agents
Fluorometholone
Lubricant Eye Drops
Anti-Inflammatory Agents, Non-Steroidal
Ophthalmic Solutions
Pharmaceutical Solutions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Allergic Agents