EICHORCondition: Allergic Conjunctivitis · Sponsor: ORA, Inc.
To evaluate the efficacy of prednisolone acetate 1% ophthalmic suspension as compared to prednisolone acetate 0.12% ophthalmic suspension, loteprednol etabonate 0.2% ophthalmic suspension, and placebo (Tears Naturale® II) in the prevention of the signs and symptoms of allergic conjunctivitis. Comparisons will be made following 1 week of twice daily (BID) dosing and 1 week of four times daily (QID) dosing.
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Inclusion Criteria: * At least 18 years of age \& either sex, any race * Willing and able to follow all instructions * Positive history of ocular allergies * Reproducible positive ocular allergic reaction induced by conjunctival allergen challenge Exclusion Criteria: * Have planned surgery during trial period * Female currently pregnant, planning a pregnancy or lactating * Use of disallowed medications * Have ocular infections, or ocular conditions that could affect study parameters * Have moderate to severe dry eye * Have used an investigational drug or device within 30 days of start of study * Female that is currently pregnant, planning a pregnancy or lactating
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Ophthalmic Research Associates | Andover, Massachusetts, United States | — |
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Source record: clinicaltrials.gov/study/NCT00689078