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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2009 by Santa Casa de Misericordia de Santos.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Santa Casa de Misericordia de Santos

ClinicalTrials.gov Identifier:

NCT00869219

First received: March 23, 2009

Last updated: March 25, 2009

Last verified: March 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

March 23, 2009

Last Updated Date

March 25, 2009

Start Date ^ICMJE

March 2009

Estimated Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Pain after instilation [ Time Frame: 5 min ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00869219 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Pain

Intervention ^ICMJE

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

Study Arm (s)

Active Comparator: Nevanac
Intervention: Drug: Nevanac
Active Comparator: Acular LS
Intervention: Drug: Acular LS

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

August 2009

Estimated Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patient over 21 years old
No ocular surface pathology
Eligible for cataract surgery

Exclusion Criteria:

Any other eye pathology other than cataract

Gender

Both

Ages

21 Years to 80 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Gustavo T Grottone, MD, MBA, MSc

551381515130

gtg2001@terra.com.br

Location Countries ^ICMJE

Brazil

Administrative Information

NCT Number ^ICMJE

NCT00869219

Other Study ID Numbers ^ICMJE

SCMisericordiaSantos

Has Data Monitoring Committee

Responsible Party

Gustavo Teixeira Grottone, Santa Casa de Misericordia de Santos

Study Sponsor ^ICMJE

Santa Casa de Misericordia de Santos

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Gustavo T Grottone, MD, MBA,MSc	SCMS
Study Chair:	João C Grottone, MD, MBA	SCMS

Information Provided By

Santa Casa de Misericordia de Santos

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top