Clinical trial NCT01697969: Confocal Analysis of Corneal Structures of Symptomatic Allergic Conjunctivitis Patients
Official title: Confocal Analysis of Corneal Structures of Symptomatic Allergic Conjunctivitis Patients Pre and Post Treatment With Olopatadine HCL Ophthalmic Solution, 0.2%
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Allergic Conjunctivitis
Keywords: allergic conjunctivitis
Pataday
Olopatadine
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2012-10-02
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.

Eligibility 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.

Primary outcomes:
measure: Patient-Assessed Ocular Itching
timeFrame: Baseline (Day 1), Day 14
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Christine Sindt, OD, FAAO
role: PRINCIPAL_INVESTIGATOR
affiliation: Alcon Research
name: Pam Kaur, MS PhD
role: STUDY_DIRECTOR
References: