NCT00869219

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4 pain

Timeline
Completed

Started Mar 2009

Shorter than P25 for phase_4 pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 25, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

March 26, 2009

Status Verified

March 1, 2009

Enrollment Period

5 months

First QC Date

March 23, 2009

Last Update Submit

March 25, 2009

Conditions

Pain

Keywords

PainPain after eyedrops

Outcome Measures

Primary Outcomes (1)

  • Pain after instilation

    5 min

Study Arms (2)

Nevanac

ACTIVE COMPARATOR
Drug: Nevanac

Acular LS

ACTIVE COMPARATOR
Drug: Acular LS

Interventions

NevanacDRUG

1 drop of NEVANAC at random eye

Nevanac
Acular LSDRUG

One drop of Acular LS

Acular LS

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Any other eye pathology other than cataract

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Santa Casa de Misericordia de Santos

Santos, São Paulo, 11055360, Brazil

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

nepafenacKetorolac

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

IndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Gustavo T Grottone, MD, MBA,MSc

    SCMS

    PRINCIPAL INVESTIGATOR

  • João C Grottone, MD, MBA

    SCMS

    STUDY CHAIR

Central Study Contacts

Gustavo T Grottone, MD, MBA, MSc

CONTACT

551381515130gtg2001@terra.com.br

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 23, 2009

First Posted

March 25, 2009

Study Start

March 1, 2009

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

March 26, 2009

Record last verified: 2009-03

Locations

BR(1)