NCT00423007

Brief Summary

The primary objective of this study is to investigate the efficacy and safety of bromfenac ophthalmic solution for treatment in subjects with a history of allergic conjunctivitis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2006

Shorter than P25 for phase_3

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

November 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 17, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

March 14, 2013

Status Verified

March 1, 2013

Enrollment Period

9 months

First QC Date

January 15, 2007

Last Update Submit

March 13, 2013

Conditions

Allergic Conjunctivitis

Outcome Measures

Primary Outcomes (1)

  • Treatment of ocular itching

Secondary Outcomes (1)

  • Treatment of chemosis, episcleral and ciliary hyperemia, ocular mucous discharge, eyelid swelling, foreign body sensation, nasal symptoms, and/or tearing

Study Arms (2)

Bromfenac

EXPERIMENTAL

Ophthalmic Solution

Drug: Bromfenac

Placebo

PLACEBO COMPARATOR

Vehicle ophthalmic solution

Drug: Placebo

Interventions

BromfenacDRUG
Bromfenac
PlaceboDRUG
Placebo

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • History of clinically active allergic conjunctivitis
  • Agree to return for all required visits
  • Agree to avoid disallowed meds

You may not qualify if:

  • Known hypersensitivity to bromfenac and salicylates

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ISTA Pharmaceuticals, Inc.

Irvine, California, 92618, United States

Location

MeSH Terms

Conditions

Conjunctivitis, Allergic

Interventions

bromfenac

Condition Hierarchy (Ancestors)

ConjunctivitisConjunctival DiseasesEye DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Jon Williams, PhD

    ISTA Pharmaceuticals, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2007

First Posted

January 17, 2007

Study Start

November 1, 2006

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

March 14, 2013

Record last verified: 2013-03

Locations

US(1)