Assessment of Alcon's Ocular Image Quantification System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01282138
First received: January 20, 2011
Last updated: December 16, 2012
Last verified: July 2012
  Purpose

The purpose of this study was to evaluate ocular responses with different allergen provocation methods.


Condition Intervention Phase
Allergic Conjunctivitis
Drug: Olopatadine hydrochloride, 0.1% ophthalmic solution (Patanol)
Other: Dextran 70 0.1%, hydroxypropyl methylcellulose 0.3% (Tears Naturale II)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Official Title: A Study to Assess Alcon's Ocular Image Quantification Using Conjunctival Allergan Provocation Testing (CAPT) and Natural Allergen Exposure in an Environmental Exposure Chamber (EEC)

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Change From Baseline in Patient-Assessed Ocular Itching, Environmental Exposure Chamber (EEC), at 3 Hours [ Time Frame: Baseline, 3 hours ] [ Designated as safety issue: No ]
    As assessed by the participant after 3 hours in the EEC. Ocular itching was graded on a 0-4 scale, where 0=none, 1=tickling sensation involving one or more corners of the eye, 2=all over tickling sensation; 3=moderate continuous itching with desire to rub; 4=severe itching with irresistible urge to rub.

  • Change From Baseline in Patient-Assessed Ocular Itching, Conjunctival Allergen Provocation Test (CAPT), at 3 Hours [ Time Frame: Baseline, 3 hours ] [ Designated as safety issue: No ]
    As assessed by the participant after 3 hours of CAPT. Ocular itching was graded on a 0-4 scale, where 0=none, 1=tickling sensation involving one or more corners of the eye, 2=all over tickling sensation; 3=moderate continuous itching with desire to rub; 4=severe itching with irresistible urge to rub.


Enrollment: 13
Study Start Date: December 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patanol
One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
Drug: Olopatadine hydrochloride, 0.1% ophthalmic solution (Patanol)
One drop twice daily in each eye for 5 days, followed by an additional drop in each eye prior to allergen test.
Other Name: Patanol®
Placebo Comparator: Tears Naturale II
One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
Other: Dextran 70 0.1%, hydroxypropyl methylcellulose 0.3% (Tears Naturale II)
One drop twice daily in each eye for 5 days, followed by an additional drop in each eye prior to allergen test.
Other Name: Tears Naturale II

Detailed Description:

Subjects demonstrating a successful allergen response to a common allergen received the first study treatment and used as instructed for 5 days, after which they entered the Environmental Exposure Chamber (EEC) for a 3-hour exposure to a known concentration of the allergen. After waiting at least 7 days, subjects received the second study treatment and used as instructed for 5 days, after which a 3-hour Conjunctival Allergen Provocation Test (CAPT) was performed with an escalating concentration of the allergen. Subjects dosed with study treatment approximately 15 minutes prior to each allergen provocation test.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of allergic conjunctivitis;
  • Active signs and symptoms of ocular allergies;
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • History of dry eye;
  • Presence of ocular infection;
  • Presence of severe or serious ocular conditions;
  • Symptoms of allergic conjunctivitis;
  • Use of topical or systemic ocular medications as specified in protocol;
  • Ocular surgery or laser surgery within 6 months of study start;
  • Unwilling to discontinue contact lens wear 72 hours prior to Visit 1 and during study period;
  • 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: NCT01282138

Locations
United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01282138     History of Changes
Other Study ID Numbers: RDG-10-278
Study First Received: January 20, 2011
Results First Received: June 20, 2012
Last Updated: December 16, 2012
Health Authority: United States: Food and Drug Administration
Canada: Ethics Review Committee

Keywords provided by Alcon Research:
Allergic conjunctivitis

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Olopatadine
Ophthalmic Solutions
Analgesics
Analgesics, Non-Narcotic
Anti-Allergic Agents
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Histamine Agents
Histamine Antagonists
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmaceutical Solutions
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014