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

This study is currently recruiting participants.

Verified by Santa Casa de Misericordia de Santos, March 2009

First Received: March 23, 2009 Last Updated: 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:	Treatment, Randomized, Double Blind (Subject, Investigator), Uncontrolled, Parallel Assignment, Safety Study
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
Nevanac: Active Comparator	Drug: Nevanac 1 drop of NEVANAC at random eye
Acular LS: Active Comparator	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, Sao Paulo
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:	Santa Casa de Misericordia de Santos ( Gustavo Teixeira Grottone )
Study ID Numbers:	SCMisericordiaSantos
Study First Received:	March 23, 2009
Last Updated:	March 25, 2009
ClinicalTrials.gov Identifier:	NCT00869219 History of Changes
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
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Physiological Effects of Drugs

Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010