A Six-Week Safety Study of an Investigational Ophthalmic Solution
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: AL-4943A Ophthalmic Solution; AL-4943A Ophthalmic Solution Vehicle
Intervention description: Inactive ingredients used as placebo
Intervention MeSH terms: Olopatadine Hydrochloride; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 518.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: ocular safety; allergic conjunctivitis

Summary:

      The purpose of this study was to evaluate the ocular safety of an investigational ophthalmic
      solution in subjects 2 years of age and older with asymptomatic eyes when administered once
      daily in both eyes for up to 6 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able and willing to comply with study protocol and follow protocol instructions.

          -  Adequate birth control methods for the duration of the study.

          -  Best-corrected visual acuity (BCVA) of 55 or greater in each eye.

          -  Willing to avoid contact lens wear during each of the study visits; contact lens wear
             also should be stable and consistent for 1 month prior to Visit 1 and expected to
             remain the same for the study duration.

          -  Willing and able to sign an Informed Consent form.

          -  Other protocol-specified inclusion criteria may apply.

        Exclusion Criteria:

          -  Women of childbearing potential that are pregnant, breastfeeding, or not in agreement
             to use adequate birth control methods to prevent pregnancy throughout the study.

          -  Evidence of contact lens care solution related ocular surface damage or giant
             papillary conjunctivitis (GPC).

          -  Any ocular infection (bacterial, viral or fungal) or history of ocular Herpes (simplex
             or zoster) or adenoviral infection in either eye or have had any ocular infection
             within 30 days prior to Visit 1.

          -  Using systemic medication(s) on a chronic dosing regimen for less than 30 days or
             changed dosage of this medication within 30 days prior to Visit 1.

          -  Current or past history of glaucoma or ocular hypertension.

          -  History of retinal detachment, diabetic retinopathy, or progressive retinal disease.

          -  Presence of ocular conditions that may affect the study outcomes.

          -  Corneal conditions affecting the corneal structure.

          -  History or evidence of any ocular surgical procedure within 1 year prior to Visit 1.

          -  Current or recent medical conditions that, in the opinion of the Investigator, would
             preclude safe participation in the study.

          -  Prior, current, or anticipated use of ophthalmic agents other than investigational
             product during study participation.

          -  Participation in any investigational study within 30 days prior to Visit 1 or
             concomitantly with this study.

          -  Known contraindications or hypersensitivities to any of the study medications or their
             components.

          -  Other protocol-specified exclusion criteria may apply.