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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
  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 4

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:

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 May 21, 2013