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

First Received on March 23, 2009. Last Updated on March 25, 2009 History of Changes

Sponsor:	Santa Casa de Misericordia de Santos
Information provided by:	Santa Casa de Misericordia de Santos
ClinicalTrials.gov Identifier:	NCT00869219

Purpose

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.

Condition	Intervention	Phase
Pain	Drug: Nevanac Drug: Acular LS	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Phase 4 Study of Topical NSAID for Ophthalmologic Use: Pain Measurement After First Drop.

Resource links provided by NLM:

Drug Information available for: Ketorolac Ketorolac tromethamine Nepafenac

U.S. FDA Resources

Further study details as provided by Santa Casa de Misericordia de Santos:

Primary Outcome Measures:

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

Estimated Enrollment:	40
Study Start Date:	March 2009
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Nevanac	Drug: Nevanac 1 drop of NEVANAC at random eye
Active Comparator: Acular LS	Drug: Acular LS One drop of Acular LS

Eligibility

Ages Eligible for Study:	21 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Any other eye pathology other than cataract

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00869219

Contacts

Contact: Gustavo T Grottone, MD, MBA, MSc

551381515130

gtg2001@terra.com.br

Locations

Brazil
Santa Casa de Misericordia de Santos	Recruiting
Santos, Sao Paulo, Brazil, 11055360
Contact: Gustavo T Grottone, MD, MBA, MSc 551381515130 gtg2001@terra.com.br
Principal Investigator: Gustavo T Grottone, MD, MBA

Sponsors and Collaborators

Santa Casa de Misericordia de Santos

Investigators

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

More Information

No publications provided

Responsible Party:	Gustavo Teixeira Grottone, Santa Casa de Misericordia de Santos
ClinicalTrials.gov Identifier:	NCT00869219 History of Changes
Other Study ID Numbers:	SCMisericordiaSantos
Study First Received:	March 23, 2009
Last Updated:	March 25, 2009
Health Authority:	Brazil: National Health Surveillance Agency

Keywords provided by Santa Casa de Misericordia de Santos:

Pain
Pain after eyedrops

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Ketorolac
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics

Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012