A Study Of The Safety And Effectiveness Of A New Treatment For Allergic Conjunctivitis

This study has been terminated.

Sponsor:

Information provided by (Responsible Party):

Alimera Sciences

ClinicalTrials.gov Identifier:

NCT00375596

First received: September 12, 2006

Last updated: January 31, 2012

Last verified: January 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	September 12, 2006
Last Updated Date	January 31, 2012
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00375596 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study Of The Safety And Effectiveness Of A New Treatment For Allergic Conjunctivitis
Official Title ^ICMJE	Not Provided
Brief Summary	This study will evaluate the safety and efficacy of a new allergy medication
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind
Condition ^ICMJE	Allergic Conjunctivitis
Intervention ^ICMJE	Drug: Ketotifen/vasoconstrictor
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: 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. Exclusion Criteria: 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
Gender	Both
Ages	6 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00375596
Other Study ID Numbers ^ICMJE	C-02-06-001
Has Data Monitoring Committee	Not Provided
Responsible Party	Alimera Sciences
Study Sponsor ^ICMJE	Alimera Sciences
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Alimera Sciences
Verification Date	January 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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