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

Not Applicable

Completed

• Conditions: Moderate to Severe Dry Eye Syndrome
• Interventions: Drug: nonsteroid anti-inflammatory drops; Drug: corticosteroids; Drug: artificial tear substitute

• Registration Number: NCT01562795
• Lead Sponsor: Wenzhou Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-22
• Study First Submitted QC: 2012-03-23
• Study First Posted: 2012-03-26
• Primary Completion: 2012-06
• Study Completion: 2012-07
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-02
• Last Update Posted: 2014-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 1	nonsteroid anti-inflammatory drops	-
group 2	nonsteroid anti-inflammatory drops	-
group 3	corticosteroids	-
group 4	artificial tear substitute	-

Primary Outcome Measures

Name	Time	Method
tear osmolarity	Day 0, Day 14

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Eye Hospital, Wenzhou Medical College; 🇨🇳 Wenzhou, Zhejiang, China