Efficacy and Safety of AL-4943A Ophthalmic Solution in Patients With Allergic Conjunctivitis Using the Conjunctival Allergen Challenge (CAC) Model

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alcon Research

ClinicalTrials.gov Identifier:

NCT01479374

First received: November 22, 2011

Last updated: June 22, 2012

Last verified: June 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	November 22, 2011
Last Updated Date	June 22, 2012
Start Date ^ICMJE	January 2012
Primary Completion Date	March 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 22, 2011)	Ocular Itching [ Time Frame: 3 minutes and 24 hours ] [ Designated as safety issue: No ] Ocular Itching Assessment at Onset and at Duration of Action timepoints
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01479374 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 22, 2011)	Conjunctival redness [ Time Frame: 3 minutes and 24 hours ] [ Designated as safety issue: No ] Total redness [ Time Frame: 24 hours ] [ Designated as safety issue: No ] sum of conjunctival, episcleral and ciliary redness
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Efficacy and Safety of AL-4943A Ophthalmic Solution in Patients With Allergic Conjunctivitis Using the Conjunctival Allergen Challenge (CAC) Model
Official Title ^ICMJE	Not Provided
Brief Summary	The purpose of this study is to assess the safety and efficacy of AL-4943A ophthalmic solution.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Allergic Conjunctivitis
Intervention ^ICMJE	Drug: AL-4943A Ophthalmic Solution Ophthalmic Solution being evaluated Drug: AL-4943A Ophthalmic Solution Vehicle Vehicle for Placebo group Drug: Pataday Active Comparator for the study
Study Arm (s)	Experimental: AL-4943A Ophthalmic Solution AL-4943A Ophthalmic Solution Intervention: Drug: AL-4943A Ophthalmic Solution Placebo Comparator: AL-4943A Ophthalmic Solution Vehicle AL-4943A Ophthalmic Solution Vehicle Intervention: Drug: AL-4943A Ophthalmic Solution Vehicle Active Comparator: Pataday Pataday Intervention: Drug: Pataday
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	Completed
Enrollment ^ICMJE	288
Completion Date	March 2012
Primary Completion Date	March 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Male or female patients, at least 18 years old, of any race or ethnicity. Must be able to be dosed in both eyes, able and willing to make the required study visits and to follow instructions. Must have a diagnostic skin test indicative of allergy for cat hair, cat dander, grasses, ragweed, dust mite, dog dander, cockroach and/or trees within 24 months of Visit 1. History of seasonal or perennial allergic conjunctivitis for at least 1 year prior to Visit 1. Positive bilateral CAC response at Visit 1 and Visit 2. Exclusion Criteria: Known history or presence of persistent dry eye syndrome, or currently requires frequent use (> 4 days per week) of artificial tears, gels or lubricants, presence of punctal plugs, use of Restasis®, or topical ocular corticosteroids for dryness of eyes. Presence of active blepharitis, active meibomian gland dysfunction, active rosacea affecting the ocular adnexa, follicular conjunctivitis, iritis, preauricular lymphadenopathy, ocular irritation not due to ocular allergy, or any other clinically significant ophthalmic abnormality that may affect the study outcomes. Presumed or actual ocular infection (bacterial, viral or fungal) or history of ocular herpes in either eye as determined by patient history and/or examination within 30 days of Visit 1. Presence of any chronic ocular degenerative condition or active intra-ocular inflammation in either eye that in the opinion of the Investigator is likely to advance/worsen during the time course of the study.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01479374
Other Study ID Numbers ^ICMJE	C-10-126
Has Data Monitoring Committee	No
Responsible Party	Alcon Research
Study Sponsor ^ICMJE	Alcon Research
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Alcon Research
Verification Date	June 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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