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NCT00869219 Clinical Trial

Comparison of Pain Sensation During Single Use of Two Topical Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

Pain Clinical Trial

Official title:
Phase 4 Study of Topical NSAID for Ophthalmologic Use: Pain Measurement After First Drop.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00869219
Other study ID # SCMisericordiaSantos
Secondary ID
Status Recruiting
Phase Phase 4
First received March 23, 2009
Last updated March 25, 2009
Start date March 2009
Est. completion date August 2009

Study information
Verified date March 2009
Source Santa Casa de Misericordia de Santos
Contact Gustavo T Grottone, MD, MBA, MSc
Phone 551381515130
Email gtg2001@terra.com.br
Is FDA regulated No
Health authority Brazil: National Health Surveillance Agency
Study type Interventional

Clinical Trial Summary

Different case reports are showing that depending on the drug used for eye drops, it might provoke a painful sensation. Actually two leading NSAIDs are used in ophthalmology. This study is intended to provide information about this parameter concerning these two drugs.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date August 2009
Est. primary completion date August 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 21 Years to 80 Years
Eligibility Inclusion Criteria:

- Patient over 21 years old

- No ocular surface pathology

- Eligible for cataract surgery

Exclusion Criteria:

- Any other eye pathology other than cataract

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Nevanac
1 drop of NEVANAC at random eye
• Acular LS
One drop of Acular LS

Locations
Country Name City State
Brazil Santa Casa de Misericordia de Santos Santos Sao Paulo

Sponsors (1)
Lead Sponsor Collaborator
Santa Casa de Misericordia de Santos

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain after instilation 5 min Yes
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