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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xiangtian Zhou, Wenzhou Medical University
ClinicalTrials.gov Identifier:
NCT01562795
First received: March 22, 2012
Last updated: January 2, 2014
Last verified: January 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Wenzhou Medical University:

Primary Outcome Measures:
  • tear osmolarity [ Time Frame: Day 0, Day 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • corneal staining [ Time Frame: 0 day,7th day and 14th day after treatment ] [ Designated as safety issue: Yes ]
  • Schirmer test(without anaesthesia) [ Time Frame: 0 day,7th day,14th day after treatment ] [ Designated as safety issue: No ]
  • tear film breakup time(TBUT) [ Time Frame: 0 day,7th day and 14th day after treatment ] [ Designated as safety issue: No ]
  • meibomian gland function [ Time Frame: 0 day,7th day and 14th day after treatment ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Xiangtian Zhou, MD, Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT01562795     History of Changes
Other Study ID Numbers: Xzhou
Study First Received: March 22, 2012
Last Updated: January 2, 2014
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Ophthalmic Solutions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antirheumatic Agents
Pharmaceutical Solutions

ClinicalTrials.gov processed this record on September 30, 2014