Confocal Analysis of Corneal Structures of Symptomatic Allergic Conjunctivitis Patients

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon Research
• Treatments: Olopatadine Hydrochloride; Ophthalmic Solutions; Pharmaceutical Solutions

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.