Confocal Analysis of Corneal Structures of Symptomatic Allergic Conjunctivitis Patients

Study Description

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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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	17 participants
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

Arms and Interventions

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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®

Outcome Measures

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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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Alcon Research
ClinicalTrials.gov Identifier:	NCT01697969 History of Changes
Other Study ID Numbers:	M-12-047
First Posted:	October 2, 2012
Results First Posted:	August 18, 2014
Last Update Posted:	August 18, 2014
Last Verified:	July 2014

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; Pharmaceutical Solutions; Ophthalmic Solutions; Olopatadine Hydrochloride; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics	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