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

March 25, 2009 updated by: Santa Casa de Misericordia de Santos

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Sao Paulo
      • Santos, Sao Paulo, Brazil, 11055360
        • Recruiting
        • Santa Casa de Misericordia de Santos
        • Contact:
        • Principal Investigator:
          • Gustavo T Grottone, MD, MBA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Any other eye pathology other than cataract

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Nevanac
Drug: Nevanac
1 drop of NEVANAC at random eye
ACTIVE_COMPARATOR: Acular LS
Drug: Acular LS
One drop of Acular LS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain after instilation
Time Frame: 5 min
5 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Santa Casa de Misericordia de Santos

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (ANTICIPATED)

August 1, 2009

Study Completion (ANTICIPATED)

August 1, 2009

Study Registration Dates

First Submitted

March 23, 2009

First Submitted That Met QC Criteria

March 24, 2009

First Posted (ESTIMATE)

March 25, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

March 26, 2009

Last Update Submitted That Met QC Criteria

March 25, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCMisericordiaSantos

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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