Confocal Analysis of Corneal Structures of Symptomatic Allergic Conjunctivitis Patients

Condition(s) targeted: Allergic Conjunctivitis

Intervention: Olopatadine hydrochloride ophthalmic solution, 0.2% (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Alcon Research

Official(s) and/or principal investigator(s):
Christine Sindt, OD, FAAO, Principal Investigator, Affiliation: University of Iowa
Pam Kaur, MS PhD, Study Director, Affiliation: Alcon Research

The purpose of this study is to descriptively evaluate the corneal structures of 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 design: Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome: Patient-Assessed Ocular Itching

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

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

Starting date: September 2012
Last updated: July 30, 2014