AL-38583 Ophthalmic Solution for Allergic Conjunctivitis Associated Inflammation

This study has been completed.
Sponsor:
Collaborator:
Ophthalmic Research Associates, Inc.
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01001091
First received: October 22, 2009
Last updated: July 15, 2014
Last verified: July 2014
  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
Drug: AL-38583 ophthalmic solution
Drug: AL-38583 ophthalmic solution vehicle
Drug: Dexamethasone ophthalmic suspension, 0.1%
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:


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 ]

Enrollment: 312
Study Start Date: December 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AL-38583 0.01%
AL-38583 ophthalmic solution, 1 drop instilled in each eye 3 times per day for 2 weeks
Drug: AL-38583 ophthalmic solution
Experimental: AL-38583 0.05%
AL-38583 ophthalmic solution, 1 drop instilled in each eye 3 times per day for 2 weeks
Drug: AL-38583 ophthalmic solution
Experimental: AL-38583 0.2%
AL-38583 ophthalmic solution, 1 drop instilled in each eye 3 times per day for 2 weeks
Drug: AL-38583 ophthalmic solution
Placebo Comparator: AL-38583 Vehicle
AL-38583 ophthalmic solution vehicle, 1 drop instilled in each eye 3 times per day for 2 weeks
Drug: AL-38583 ophthalmic solution vehicle
Inactive ingredients used as a placebo comparator
Active Comparator: MAXIDEX
Dexamethasone ophthalmic suspension, 0.1%, 1 drop instilled in each eye 3 times per day for 2 weeks
Drug: Dexamethasone ophthalmic suspension, 0.1%
Other Name: MAXIDEX

  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.
  • Other protocol-defined inclusion criteria may apply.

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.
  • Other protocol-defined exclusion criteria may apply.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Alcon Research
Ophthalmic Research Associates, Inc.
Investigators
Study Director: Michela Palmer Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01001091     History of Changes
Other Study ID Numbers: C-09-034
Study First Received: October 22, 2009
Last Updated: July 15, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Alcon Research:
Conjunctivitis
conjunctival inflammation
ocular allergies

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pharmaceutical Solutions
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Ophthalmic Solutions
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents
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 September 16, 2014