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Completed

NCT Number: NCT01562795

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

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.

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Key information

Conditions

Moderate to Severe Dry Eye Syndrome

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eye Hospital, Wenzhou Medical College

Wenzhou, Zhejiang, 325027, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nonsteroid anti-inflammatory drops

Drug

nonsteroid anti-inflammatory drops plus artificial tear substitute

Other names: prunoprefen

Corticosteroids

Drug

corticosteroids plus artificial tear substitute

Other names: Fluorometholone

artificial tear substitute

Drug

artificial tear substitute alone

Primary outcomes

  1. tear osmolarity

    Time frame: Day 0, Day 14

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Wenzhou Medical University

Other

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 26, 2012
Registry last updated
Jan 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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