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Confocal Analysis of Corneal Structures of Symptomatic Allergic Conjunctivitis Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01697969
First received: September 27, 2012
Last updated: July 30, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Allergic Conjunctivitis
Drug: Olopatadine hydrochloride ophthalmic solution, 0.2%
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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%

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Patient-Assessed Ocular Itching [ Time Frame: Baseline (Day 1), Day 14 ] [ Designated as safety issue: No ]
    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.


Enrollment: 17
Study Start Date: September 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01697969

Locations
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242-1091
Sponsors and Collaborators
Alcon Research
Investigators
Principal Investigator: Christine Sindt, OD, FAAO University of Iowa
Study Director: Pam Kaur, MS PhD Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01697969     History of Changes
Other Study ID Numbers: M-12-047
Study First Received: September 27, 2012
Results First Received: July 30, 2014
Last Updated: July 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
allergic conjunctivitis
Pataday
Olopatadine

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Olopatadine
Ophthalmic Solutions
Pharmaceutical 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
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014