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 26, 2013
Last verified: July 2013
  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: Day 1 ] [ Designated as safety issue: No ]
    As rated by the patient on a 0-4 scale.

  • Patient-Assessed Ocular Itching [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    As rated by the patient on a 0-4 scale.


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
One drop of olopatadine 0.2% once daily in both eyes for 14 days
Drug: Olopatadine hydrochloride ophthalmic solution, 0.2%
One drop once daily in both eyes for 14 days
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
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
Last Updated: July 26, 2013
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, Immediate
Hypersensitivity
Immune System Diseases
Olopatadine
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Allergic Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014