NCT00375596

Brief Summary

This study will evaluate the safety and efficacy of a new allergy medication

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 13, 2006

Completed
Last Updated

February 20, 2015

Status Verified

February 1, 2015

First QC Date

September 12, 2006

Last Update Submit

February 19, 2015

Conditions

Allergic Conjunctivitis

Outcome Measures

Primary Outcomes (1)

  • Safety and efficacy of a new allergy medication

    STUDY WITHDRAWN PRIOR TO OUTCOME DETERMINATION

    0

Interventions

Ketotifen/vasoconstrictorDRUG

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Be at least 6 years of age, of any race, or either gender.
  • Have a positive allergic history of ocular allergies and a positive skin test reaction to cat hair/dander, ragweed, tree and/or grass pollen within the past 24 months.
  • Have a calculated best-corrected visual acuity of 0.6 logMar or better in each eye as measured using an ETDRS chart.
  • Positive bilateral CAC reaction at Visit 1 \& 2.

You may not qualify if:

  • Have any known contraindications, allergies, or sensitivities to the use of any of the study medications, or their components.
  • Any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters
  • Manifest signs or symptoms of clinically active allergic conjunctivitis in either eye at the baseline slit-lamp exam of any visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Conjunctivitis, Allergic

Interventions

KetotifenVasoconstrictor Agents

Condition Hierarchy (Ancestors)

ConjunctivitisConjunctival DiseasesEye DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCardiovascular AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses
0

Study Design

Study Type
interventional
Phase
phase 2
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2006

First Posted

September 13, 2006

Last Updated

February 20, 2015

Record last verified: 2015-02