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

Tracking Information
First Submitted Date  ICMJE September 27, 2012
First Posted Date  ICMJE October 2, 2012
Results First Submitted Date  ICMJE July 30, 2014
Results First Posted Date  ICMJE August 18, 2014
Last Update Posted Date August 18, 2014
Study Start Date  ICMJE September 2012
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 30, 2014)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 1, 2012)
  • Patient-Assessed Ocular Itching [ Time Frame: Day 1 ]
    As rated by the patient on a 0-4 scale.
  • Patient-Assessed Ocular Itching [ Time Frame: Day 14 ]
    As rated by the patient on a 0-4 scale.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Confocal Analysis of Corneal Structures of Symptomatic Allergic Conjunctivitis Patients
Official Title  ICMJE Confocal Analysis of Corneal Structures of Symptomatic Allergic Conjunctivitis Patients Pre and Post Treatment With Olopatadine HCL Ophthalmic Solution, 0.2%
Brief Summary The purpose of this study is to descriptively evaluate the corneal structures of allergic conjunctivitis patients.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Allergic Conjunctivitis
Intervention  ICMJE Drug: Olopatadine hydrochloride ophthalmic solution, 0.2%
Other Name: PATADAY®
Study Arms  ICMJE Experimental: Pataday
Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop once daily in both eyes for 14 days
Intervention: Drug: Olopatadine hydrochloride ophthalmic solution, 0.2%
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 26, 2013)
17
Original Estimated Enrollment  ICMJE
 (submitted: October 1, 2012)
25
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01697969
Other Study ID Numbers  ICMJE M-12-047
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alcon Research
Study Sponsor  ICMJE Alcon Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christine Sindt, OD, FAAO University of Iowa
Study Director: Pam Kaur, MS PhD Alcon Research
PRS Account Alcon Research
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP