Confocal Analysis of Corneal Structures of Symptomatic Allergic Conjunctivitis Patients

Confocal Analysis of Corneal Structures of Symptomatic Allergic Conjunctivitis Patients Pre and Post Treatment With Olopatadine HCL Ophthalmic Solution, 0.2%

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

Study Overview

• Status: Completed
• Conditions: Allergic Conjunctivitis
• Intervention / Treatment: Drug: Olopatadine hydrochloride ophthalmic solution, 0.2%

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: Interventional
• Enrollment (Actual): 17
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242-1091
      • University of Iowa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: PATADAY®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-Assessed Ocular Itching	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.	Baseline (Day 1), Day 14

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Principal Investigator: Christine Sindt, OD, FAAO, University of Iowa; Study Director: Pam Kaur, MS PhD, Alcon Research

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: September 27, 2012
• First Submitted That Met QC Criteria: October 1, 2012
• First Posted (Estimate): October 2, 2012

Study Record Updates

• Last Update Posted (Estimate): August 18, 2014
• Last Update Submitted That Met QC Criteria: July 30, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: allergic conjunctivitis; Pataday; Olopatadine
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Eye Diseases; Hypersensitivity; Conjunctival Diseases; Conjunctivitis; Conjunctivitis, Allergic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Pharmaceutical Solutions; Histamine H1 Antagonists, Non-Sedating; Ophthalmic Solutions; Olopatadine Hydrochloride
• Other Study ID Numbers: M-12-047