NCT00828477

Brief Summary

The objective of this study is to evaluate and compare the comfort of bromfenac or nepafenac following SLT.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_4

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

Study Start

First participant enrolled

January 1, 2009

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2009

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 26, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

June 10, 2009

Status Verified

June 1, 2009

Enrollment Period

5 months

First QC Date

January 14, 2009

Last Update Submit

June 8, 2009

Conditions

Intraocular Pressure

Outcome Measures

Primary Outcomes (1)

  • Tolerability of study medication

    28 days

Secondary Outcomes (2)

  • Intraocular pressure changes

    28 days

  • Visual Acuity

    28 days

Study Arms (2)

1

ACTIVE COMPARATOR

Xibrom (bromfenac)

Drug: Xibrom

2

ACTIVE COMPARATOR

Nevanac (nepafenac)

Drug: Nevanac

Interventions

XibromDRUG

Xibrom: two times a day for seven days in the first eye.

Also known as: bromfenac
1
NevanacDRUG

Nevanac: three times a day for seven days in the second eye.

Also known as: nepafenac
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \> 18 years old, either gender or any race.
  • Diagnosis of open-angle glaucoma or ocular hypertension requiring laser trabeculoplasty.
  • Completion of written and informed consent/authorization prior to any study related procedures.
  • Able to follow study protocol and likely to complete study schedule.

You may not qualify if:

  • Known sensitivity to NSAIDs.
  • History of neovascular or ocular inflammatory disease.
  • Current use of topical or systemic anti-inflammatory medications.
  • Females of childbearing potential.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Coburn-Kleinfeldt Eye Clinic

3340 6 Mile Rd Livonia, Michigan, 48152, United States

Location

MeSH Terms

Interventions

bromfenacnepafenac

Study Officials

  • Nate Kleinfeldt, M.D

    Coburn-Kleinfeldt Eye Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
NETWORK

Study Record Dates

First Submitted

January 14, 2009

First Posted

January 26, 2009

Study Start

January 1, 2009

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

June 10, 2009

Record last verified: 2009-06

Locations

US(1)