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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: August 2009

Interventions

  • Drug: Nevanac
    • 1 drop of NEVANAC at random eye
  • Drug: Acular LS
    • One drop of Acular LS

Arms, Groups and Cohorts

  • Active Comparator: Nevanac
  • Active Comparator: Acular LS

Clinical Trial Outcome Measures

Primary Measures

  • Pain after instilation
    • Time Frame: 5 min

Participating in This Clinical Trial

Inclusion Criteria

  • Patient over 21 years old – No ocular surface pathology – Eligible for cataract surgery Exclusion Criteria:

  • Any other eye pathology other than cataract

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Santa Casa de Misericordia de Santos
  • Provider of Information About this Clinical Study
    • Gustavo Teixeira Grottone, Santa Casa de Misericordia de Santos
  • Overall Official(s)
    • Gustavo T Grottone, MD, MBA,MSc, Principal Investigator, SCMS
    • João C Grottone, MD, MBA, Study Chair, SCMS
  • Overall Contact(s)
    • Gustavo T Grottone, MD, MBA, MSc, 551381515130, gtg2001@terra.com.br

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