NCT00347503

Brief Summary

Evaluation of the aqueous concentrations of 2 topical NSAIDS as well as the PGE2 inhibition in human patients.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

June 29, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
Last Updated

July 13, 2007

Status Verified

July 1, 2007

First QC Date

June 29, 2006

Last Update Submit

July 12, 2007

Conditions

Cataract

Interventions

ketorolac 0.4%, bromfenac 0.09%DRUG

Eligibility Criteria

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

You may qualify if:

  • Healthy Male/Female 21 years of age of older.
  • Patient understands and is willing to sign the written informed consent form
  • Likely to complete the entire course of the study.
  • Patient is scheduled to undergo cataract surgery
  • Female patients of childbearing potential must have had a regular menstrual cycle prior to study entry (a female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation).
  • Patient is willing and able to administer eye drops and record the times the drops were instilled

You may not qualify if:

  • Patient has been using a topical NSAID within 1 week of study entry
  • Patient has a known sensitivity to any of the ingredients in the study medications
  • Patient has sight in only one eye
  • Patient has a history of previous intraocular surgery
  • Patient's doctor has determined they have a condition (i.e., UNCONTROLLED systemic disease) or are in a situation that may put them at significant risk, confound the study results or may interfere significantly with their participation in the study
  • Female patients who are pregnant, nursing an infant or planning a pregnancy
  • Patients who are currently involved in another investigational study or have participated in one within the 30 days prior to entering this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bucci Laser Vision

Wilkes-Barre, Pennsylvania, 18702, United States

Location

MeSH Terms

Conditions

Cataract

Interventions

Ketorolac

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Frank Bucci

    Bucci Vision Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 29, 2006

First Posted

July 4, 2006

Last Updated

July 13, 2007

Record last verified: 2007-07

Locations

US(1)