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

March 23, 2009
March 25, 2009
March 2009
August 2009   (final data collection date for primary outcome measure)
Pain after instilation [ Time Frame: 5 min ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00869219 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Comparison of Pain Sensation During Single Use of Two Topical Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Pain
  • Drug: Nevanac
    1 drop of NEVANAC at random eye
  • Drug: Acular LS
    One drop of Acular LS
  • Active Comparator: Nevanac
    Intervention: Drug: Nevanac
  • Active Comparator: Acular LS
    Intervention: Drug: Acular LS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
August 2009
August 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Any other eye pathology other than cataract
Both
21 Years to 80 Years
Yes
Contact: Gustavo T Grottone, MD, MBA, MSc 551381515130 gtg2001@terra.com.br
Brazil
 
NCT00869219
SCMisericordiaSantos
No
Gustavo Teixeira Grottone, Santa Casa de Misericordia de Santos
Santa Casa de Misericordia de Santos
Not Provided
Principal Investigator: Gustavo T Grottone, MD, MBA,MSc SCMS
Study Chair: João C Grottone, MD, MBA SCMS
Santa Casa de Misericordia de Santos
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP