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AL-38583 Ophthalmic Solution for Allergic Conjunctivitis Associated Inflammation

This study has been completed.
Sponsor:
Collaborator:
Ophthalmic Research Associates, Inc.
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT01001091
First received: October 22, 2009
Last updated: June 3, 2010
Last verified: June 2010
History of Changes
  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 2

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
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 May 19, 2013