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AL-38583 Ophthalmic Solution for Allergic Conjunctivitis Associated Inflammation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01001091
Recruitment Status : Completed
First Posted : October 23, 2009
Last Update Posted : July 17, 2014
Sponsor:
Collaborator:
Ophthalmic Research Associates, Inc.
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
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 or disease Intervention/treatment Phase
Allergic Conjunctivitis Drug: AL-38583 ophthalmic solution Drug: AL-38583 ophthalmic solution vehicle Drug: Dexamethasone ophthalmic suspension, 0.1% Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 312 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : December 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Mean area under the curve 0-7 hours post-CAC for conjunctival redness scores [ Time Frame: Day 14 ]

Secondary Outcome Measures :
  1. Mean daily diary ocular redness scores [ Time Frame: 2 week period between Day 0 and Day 14 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01001091


Sponsors and Collaborators
Alcon Research
Ophthalmic Research Associates, Inc.
Investigators
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Study Director: Michela Palmer Alcon Research
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01001091    
Other Study ID Numbers: C-09-034
First Posted: October 23, 2009    Key Record Dates
Last Update Posted: July 17, 2014
Last Verified: July 2014
Keywords provided by Alcon Research:
Conjunctivitis
conjunctival inflammation
ocular allergies
Additional relevant MeSH terms:
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Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Dexamethasone
Pharmaceutical Solutions
Ophthalmic Solutions
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents