Confocal Analysis of Corneal Structures of Symptomatic Allergic Conjunctivitis Patients
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: Olopatadine hydrochloride ophthalmic solution, 0.2%
Intervention MeSH terms: Olopatadine Hydrochloride; Ophthalmic Solutions
Phase: Phase 4
Study type: Interventional
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: allergic conjunctivitis; Pataday; Olopatadine

Summary:

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

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.