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

Wenzhou Medical University

Status: Completed

Conditions: Moderate to Severe Dry Eye Syndrome

Treatments: Drug: corticosteroids; Drug: artificial tear substitute; Drug: nonsteroid anti-inflammatory drops

Study type: Interventional

Funder types: Other

Identifiers

NCT01562795

Xzhou

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 4 patient groups

group 1

Experimental group

Treatment:

Drug: nonsteroid anti-inflammatory drops

Drug: nonsteroid anti-inflammatory drops

group 2

Experimental group

Treatment:

Drug: nonsteroid anti-inflammatory drops

Drug: nonsteroid anti-inflammatory drops

group 3

Experimental group

Treatment:

Drug: corticosteroids

group 4

Other group

Treatment:

Drug: artificial tear substitute