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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. The completion date has passed and the status has not been verified in more than two years.
Verified March 2009 by Santa Casa de Misericordia de Santos.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00869219
First Posted: March 25, 2009
Last Update Posted: March 26, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Santa Casa de Misericordia de Santos
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:


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

Primary Outcome Measures:
  • Pain after instilation [ Time Frame: 5 min ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Gustavo Teixeira Grottone, Santa Casa de Misericordia de Santos
ClinicalTrials.gov Identifier: NCT00869219     History of Changes
Other Study ID Numbers: SCMisericordiaSantos
First Submitted: March 23, 2009
First Posted: March 25, 2009
Last Update Posted: March 26, 2009
Last Verified: March 2009

Keywords provided by Santa Casa de Misericordia de Santos:
Pain
Pain after eyedrops

Additional relevant MeSH terms:
Anti-Inflammatory Agents, Non-Steroidal
Ketorolac Tromethamine
Ketorolac
Nepafenac
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action