Safety and Efficacy Study of AL-53817 and AL-78843 Ophthalmic Solutions for Allergic Conjunctivitis

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon Research
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Ophthalmic Solutions; Pharmaceutical Solutions

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.