AL-38583 Ophthalmic Solution for Allergic Conjunctivitis Associated Inflammation - Full Text View

Sponsor:	Alcon Research
Collaborator:	Ophthalmic Research Associates, Inc.
Information provided by:	Alcon Research
ClinicalTrials.gov Identifier:	NCT01001091

Purpose

The purpose of this study is to assess the safety and efficacy of AL-38583 in the treatment of the signs of inflammation associated with allergic conjunctivitis.

Condition	Intervention	Phase
Allergic Conjunctivitis Associated Inflammation	Drug: AL-38583 Ophthalmic Solution Drug: AL-38583 Ophthalmic Solution Vehicle Drug: Dexamethasone Ophthalmic Suspension	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Pinkeye

Drug Information available for: Dexamethasone Dexamethasone acetate Doxiproct plus Dexamethasone Sodium Phosphate

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:

Mean area under the curve 0-7 hours post-CAC for conjunctival redness scores [ Time Frame: Day 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mean daily diary ocular redness scores [ Time Frame: 2 week period between Day 0 and Day 14 ] [ Designated as safety issue: No ]

Estimated Enrollment:	180
Study Start Date:	December 2009
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: AL-38583 0.01% AL-38583 0.01%	Drug: AL-38583 Ophthalmic Solution One drop in each eye three times per day for 2 weeks
Experimental: AL-38583 0.05% AL-38583 0.05%	Drug: AL-38583 Ophthalmic Solution One drop in each eye three times per day for 2 weeks
Experimental: AL-38583 0.2% AL-38583 0.2%	Drug: AL-38583 Ophthalmic Solution One drop in each eye three times per day for 2 weeks
Placebo Comparator: AL-38583 Vehicle AL-38583 Vehicle	Drug: AL-38583 Ophthalmic Solution Vehicle One drop in each eye three times per day for 2 weeks
Active Comparator: Dexamethasone Ophthalmic Suspension Dexamethasone Ophthalmic Suspension	Drug: Dexamethasone Ophthalmic Suspension One drop in each eye three times per day for 2 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Presence of signs and symptoms of ocular inflammation in both eyes.
Have a positive CAC response at Visit 1.
Able to avoid the use of disallowed medications as well as contact lens wear for the specified period prior to Visit 1, and for the duration of the study.

Exclusion Criteria:

Have known history or presence of persistent dry eye syndrome.
Presence of any ophthalmic abnormality that may affect the study outcomes.
Have a history of moderate to severe allergic asthma reaction to mountain cedar or the perennial allergens used in the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01001091

Locations

United States, Texas
Contact Alcon Call Center For Trial Locations
Fort Worth, Texas, United States, 76134

Sponsors and Collaborators

Alcon Research

Ophthalmic Research Associates, Inc.

More Information

No publications provided

Responsible Party:	Michela Montecchi-Palmer, Clinical Trial Manager, Alcon Research, Ltd.
ClinicalTrials.gov Identifier:	NCT01001091 History of Changes
Other Study ID Numbers:	C-09-034
Study First Received:	October 22, 2009
Last Updated:	June 3, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Alcon Research:

Conjunctivitis
conjunctival inflammation
ocular allergies

Additional relevant MeSH terms:

Conjunctivitis
Conjunctivitis, Allergic
Inflammation
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pathologic Processes
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses

Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012