Study Evaluating the Safety of KetoNaph Ophthalmic Solution in Healthy Volunteers
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: KetoNaph; Vehicle
Intervention description: Ophthalmic Solution administered BID for 6 weeks; Vehicle of KetoNaph ophthalmic solution administered bid for six weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Screening
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 534.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is being conducted to evaluate the safety of KetoNaph ophthalmic solution in
      healthy adult subjects and in pediatric subjects with a history or family history of ocular
      allergy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects less than 18 years of age, have either a history or family history of ocular
             allergy.

          -  ocular health within normal limits, including a calculated best-corrected visual
             acuity of 0.3 logMar or better, in each eye. For subjects under 10 years old who are
             developmentally unable to use the ETDRS chart, visual acuity will be made using the
             LEA symbols. For these subjects, 20-foot Snellen equivalent units of 20/63 or better
             in both eyes will be required.

        Exclusion Criteria:

          -  Contraindications or sensitivities to the use of any of the investigational product(s)
             or their components.

          -  Subjects less than 18 years of age that have had symptoms and/or signs of allergic
             conjunctivitis/rhinitis and/or treatment with topical or systemic anti-allergy
             therapy, or have had a history of ragweed hypersensitivity during the 21-day period
             prior to visit 1.

          -  Surgical intervention within three months prior to Visit 1 or during the refractive
             surgery within the past 6 months.

          -  A known history of retinal detachment, diabetic retinopathy, or active retinal
             disease;

          -  An active ocular infection (bacterial, viral or fungal

          -  Use of any topical ophthalmic agents other than investigational products during study
             participation or within 5 days of beginning study treatment.

          -  Current or anticipated use of contact lenses during study participation or within 5
             days of beginning study treatment.

          -  Current, prior (within 14 days of beginning study treatment) or anticipated use of
             systemic corticosteroids, and/or any other systemic medications which the Investigator
             feels may confound study data or interfere with the subject's study participation.
             Prior (within 21 days of beginning study treatment), current or anticipated use of any
             topical (including nasal) or systemic anti-allergy medications.

          -  Intraocular pressure (IOP) that is less than 5 mmHg or greater than 22 mmHg or have a
             normal IOP with a diagnosis of glaucoma.