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Confocal Analysis of Corneal Structures of Symptomatic Allergic Conjunctivitis Patients

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. Identifier: NCT01697969
Recruitment Status : Completed
First Posted : October 2, 2012
Results First Posted : August 18, 2014
Last Update Posted : August 18, 2014
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
The purpose of this study is to descriptively evaluate the corneal structures of allergic conjunctivitis patients.

Condition or disease Intervention/treatment Phase
Allergic Conjunctivitis Drug: Olopatadine hydrochloride ophthalmic solution, 0.2% Phase 4

Detailed Description:
Heidelberg Retina Tomograph (HRT) will be used to descriptively evaluate the corneal structures and assess the immune cell status of allergic conjunctivitis patients pre- and post-treatment with olopatadine 0.2% in relation to a normative database.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Confocal Analysis of Corneal Structures of Symptomatic Allergic Conjunctivitis Patients Pre and Post Treatment With Olopatadine HCL Ophthalmic Solution, 0.2%
Study Start Date : September 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye

Arm Intervention/treatment
Experimental: Pataday
Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop once daily in both eyes for 14 days
Drug: Olopatadine hydrochloride ophthalmic solution, 0.2%
Other Name: PATADAY®

Primary Outcome Measures :
  1. Patient-Assessed Ocular Itching [ Time Frame: Baseline (Day 1), Day 14 ]
    The patient rated the severity of ocular itching using a predetermined 0-4 scale, where 0=none and 4=severe itching with irresistible urge to rub. Each eye was rated separately. A 2-week washout period from prior allergy medication (if applicable) preceded the baseline assessment.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Read, sign, and date an Ethics Committee reviewed and approved informed consent form.
  • Females of childbearing potential who:

    • Are not breast-feeding;
    • Do not intend to become pregnant for the duration of the study;
    • Are using adequate birth control methods and agree to continue for the duration of the study.
  • Able to read, understand and answer questions by investigator.
  • Willing and able to attend all required study visits and follow directions as stipulated by the protocol and investigator.
  • History of allergic conjunctivitis (within the past 12 months) and active signs and symptoms of ocular allergies for which treatment is necessary, in the opinion of the investigator.
  • Visual acuity correctable to 20/30 (Snellen) or better in each eye at distance with or without glasses correction.
  • Ocular health within normal limits as determined by the investigator.
  • No contact lens wear 14 days prior to enrollment and willing to not wear contact lenses for the duration of the study.
  • Willing to follow a 14-day washout period due to contraindicated medication use, if deemed necessary by investigator.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Contraindications or hypersensitivity to the use of the test article or its components.
  • Inability or unwillingness to follow all study instructions and complete study visits as required.
  • Only one sighted eye or visual acuity not correctable to 20/30 (Snellen) in both eyes at the Screening Visit.
  • Ocular trauma within 6 months prior to Visit 1 in either eye.
  • Any ocular surgical intervention within six months prior to Visit 1 or anticipation of ocular surgery during the study.
  • Presumed or actual ocular infection within 30 days prior to Visit 1.
  • Any severe or serious ocular condition or significant illness.
  • Any abnormal slit-lamp findings at the time of the Screening Visit.
  • Contact lens wear within 14 days prior to the study start and unwillingness to undergo a wash-out period of 14 days; unwilling to not wear contact lenses for the duration of the study.
  • Use of over-the-counter (OTC) ocular medications within the past 14 days unless willing to follow wash out period.
  • Use of topical or systemic ocular medications requiring longer than a two-week washout period.
  • Participation in any other investigational study in the 30-day period before entry into this study (i.e., Visit 1) or concomitantly with this study.
  • Women who are pregnant, nursing, or of childbearing potential not utilizing adequate birth control measures.
  • 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 identifier (NCT number): NCT01697969

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United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242-1091
Sponsors and Collaborators
Alcon Research
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Principal Investigator: Christine Sindt, OD, FAAO University of Iowa
Study Director: Pam Kaur, MS PhD Alcon Research
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Responsible Party: Alcon Research Identifier: NCT01697969    
Other Study ID Numbers: M-12-047
First Posted: October 2, 2012    Key Record Dates
Results First Posted: August 18, 2014
Last Update Posted: August 18, 2014
Last Verified: July 2014
Keywords provided by Alcon Research:
allergic conjunctivitis
Additional relevant MeSH terms:
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Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Immune System Diseases
Olopatadine Hydrochloride
Ophthalmic Solutions
Pharmaceutical Solutions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action