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

Moderate to Severe Dry Eye Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01562795
• Other study ID #: Xzhou
• Status: Completed
• Phase: N/A
• First received: March 22, 2012
• Last updated: January 2, 2014
• Start date: March 2012
• Est. completion date: July 2012

Study information

• Verified date: January 2014
• Source: Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca
• Moderate to Severe Dry Eye Syndrome

Intervention

Drug:
• nonsteroid anti-inflammatory drops
nonsteroid anti-inflammatory drops plus artificial tear substitute
• nonsteroid anti-inflammatory drops
nonsteroid anti-inflammatory drops plus artificial tear substitute
• corticosteroids
corticosteroids plus artificial tear substitute
• artificial tear substitute
artificial tear substitute alone

Locations

Country	Name	City	State
China	Eye Hospital, Wenzhou Medical College	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tear osmolarity		Day 0, Day 14	No
Secondary	corneal staining		0 day,7th day and 14th day after treatment	Yes
Secondary	Schirmer test(without anaesthesia)		0 day,7th day,14th day after treatment	No
Secondary	tear film breakup time(TBUT)		0 day,7th day and 14th day after treatment	No
Secondary	meibomian gland function		0 day,7th day and 14th day after treatment	No