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

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ClinicalTrials.gov Identifier: NCT01562795
Recruitment Status : Completed
First Posted : March 26, 2012
Last Update Posted : January 3, 2014
Sponsor:
Information provided by (Responsible Party):
Xiangtian Zhou, Wenzhou Medical University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Moderate to Severe Dry Eye Syndrome Drug: nonsteroid anti-inflammatory drops Drug: corticosteroids Drug: artificial tear substitute Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
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
Study Start Date : March 2012
Actual Primary Completion Date : June 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arms and Interventions
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Arm Intervention/treatment
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


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

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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
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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
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China, Zhejiang
Eye Hospital, Wenzhou Medical College
Wenzhou, Zhejiang, China, 325027
Sponsors and Collaborators
Wenzhou Medical University
Investigators
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Principal Investigator: Wei Chen, MD,PhD Eye Hospital, Wenzhou Medical College, China
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Xiangtian Zhou, MD, Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT01562795    
Other Study ID Numbers: Xzhou
First Posted: March 26, 2012    Key Record Dates
Last Update Posted: January 3, 2014
Last Verified: January 2014
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Fluorometholone
 Anti-Inflammatory Agents
Lubricant Eye Drops
Ophthalmic Solutions
Pharmaceutical Solutions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Allergic Agents