NCT00364091

Brief Summary

The purpose of this summary is to evaluate the efficacy and safety of R89674 0.025% ophthalmic solution compared with placebo or an active control in subjects with seasonal allergic conjunctivitis

Trial Health

80
On Track

Trial Health Score

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

Enrollment
365

participants targeted

Target at P50-P75 for phase_3

Geographic Reach
1 country

6 active sites

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

August 1, 2006

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 15, 2006

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Last Updated

September 27, 2011

Status Verified

September 1, 2011

Enrollment Period

2 months

First QC Date

August 11, 2006

Last Update Submit

September 26, 2011

Conditions

Allergic Conjunctivitis

Keywords

allergic conjunctivitis, ophthalmology, multicenter, controlled

Outcome Measures

Primary Outcomes (1)

  • Ocular itching and redness scores at defined timepoints

Secondary Outcomes (1)

  • QOL, severity of chemosis & redness, ocular itching and redness scores at defined timepoints

Interventions

R89674 0.025% ophthalmic solutionDRUG

Eligibility Criteria

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

You may qualify if:

  • history of positive diagnostic test for ragweed within the past 2 years;
  • positive bilateral response to ragweed as induced by conjunctival allergen challenge

You may not qualify if:

  • ocular infection;
  • history of retinal detachment, diabetic neuropathy, or any progressive retinal disease;
  • moderate to severe asthma;
  • dry eye syndrome;
  • history of severe, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal or autoimmune disease;
  • pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Unknown Facility

Louisville, Kentucky, United States

Location

Unknown Facility

North Andover, Massachusetts, United States

Location

Unknown Facility

Creve Coeur, Missouri, United States

Location

Unknown Facility

Charlotte, North Carolina, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Unknown Facility

Memphis, Tennessee, United States

Location

MeSH Terms

Conditions

Conjunctivitis, Allergic

Interventions

Ophthalmic Solutions

Condition Hierarchy (Ancestors)

ConjunctivitisConjunctival DiseasesEye DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Study Officials

  • Reza Haque, MD

    Vistakon Pharmaceuticals

    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

August 11, 2006

First Posted

August 15, 2006

Study Start

August 1, 2006

Primary Completion

October 1, 2006

Last Updated

September 27, 2011

Record last verified: 2011-09

Locations

US(6)