safety and efficacy study of al-53817 and al-78843 ophthalmic solutions for allergic conjunctivitis

Conditions: Allergic Conjunctivitis

Summary: the purpose of this study is to evaluate two investigational ophthalmic solutions for reduction in ocular redness in subjects with allergic conjunctivitis.

eligible subjects attended 8 study visits, 5 of which included a 3-hour period of ragweed exposure in an environmental exposure chamber. at the sixth visit, subjects received study product and began dosing for up to 9 days. the final visit was the final day of dosing. participation in this study lasted up to 68 days.

Eligibility criteria:
inclusion criteria: * sign informed consent * use of condom by sexually active males for the entire duration of the study. * best corrected visual acuity of 55 or greater in each eye as measured by etdrs (letters read method). * able and willing to comply with study protocol and follow protocol instructions. * able to avoid any of the topical ocular or systemic excluded medications during the entire study period. * at least 1 year subject-reported or physician-diagnosed history (prior to screen visit) of allergic conjunctivitis during the ragweed season. * positive skin prick test for short ragweed allergen within 12 months prior to screen visit. * significant staff-assessed ocular redness in at least one region in each eye within the 3 hour period of allergen exposure in the eec (screen visits). * other protocol-defined inclusion criteria may apply. exclusion criteria: * women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for at least 1 week following the last dose of investigational product. * presence of any ocular infection, history of ocular herpes (simplex or zoster) or adenoviral infection in either eye. * history of any ocular infection, physician or subject diagnosed, within 30 days prior to screen visit. * presence of glaucoma, past history of, or diagnosis of glaucoma or ocular hypertension. * presence of blepharitis, active rosacea affecting the ocular adnexa, meibomian gland dysfunction, follicular conjunctivitis, intraocular inflammation, or preauricular lymphadenopathy or any other ophthalmic abnormality that may affect the study outcomes. * corneal conditions affecting the corneal structure. * unwilling to discontinue contact lens wear during the study period. * any ocular surgery including ocular laser procedures within 1 year prior to screen visit. * current or recent (\<6 months prior to screen visit) history of severe, unstable, or uncontrolled autoimmune, neurological, cardiovascular, hematological, hepatic, renal, psychological, respiratory, gastrointestinal and/or immunological disease or evidence of other diseases based upon a review of medical history and/or physical examination that, in the opinion of the investigator, would preclude safe subject participation in the study. * receiving treatment for anxiety and/or depression at the screen visit; any history of suicide attempt. * participation in any investigational study within 30 days of screen visit or concomitantly with this study. * known contraindications or hypersensitivities to any of the study medications or their components * confirmed (by physician or optometrist) diagnosis of dry eye. * history of sensitivity or adverse reaction to steroids. * known allergic reaction that is unresponsive to corticosteroids or non-steroidal anti-inflammatory drugs (nsaids). * physician diagnosed asthma (except inactive childhood asthma and exercise-induced asthma). * evidence of active inflammation in the eye as determined by the dilated fundus examination conducted at screen c visit. * any corneal swelling or haze as determined by the slitlamp examination conducted at screen c visit. * other protocol-defined exclusion criteria may apply.

Keywords: allergic conjunctivitis red eyes eyelid swelling ragweed allergies itchy eyes ocular redness chemosis tearing watery eyes