Assessment of Alcon's Ocular Image Quantification System

Subjects demonstrating a successful allergen response to a common allergen received the first study treatment and used as instructed for 5 days, after which they entered the Environmental Exposure Chamber (EEC) for a 3-hour exposure to a known concentration of the allergen. After waiting at least 7 days, subjects received the second study treatment and used as instructed for 5 days, after which a 3-hour Conjunctival Allergen Provocation Test (CAPT) was performed with an escalating concentration of the allergen. Subjects dosed with study treatment approximately 15 minutes prior to each allergen provocation test.

• Olopatadine hydrochloride, 0.1% ophthalmic solution (Patanol) (Drug), also known as Patanol®: One drop twice daily in each eye for 5 days, followed by an additional drop in each eye prior to allergen test.
• Dextran 70 0.1%, hydroxypropyl methylcellulose 0.3% (Tears Naturale II) (Other), also known as Tears Naturale II: One drop twice daily in each eye for 5 days, followed by an additional drop in each eye prior to allergen test.

Primary outcomes

• Change From Baseline in Patient-Assessed Ocular Itching, Environmental Exposure Chamber (EEC), at 3 Hours [Baseline, 3 hours]: As assessed by the participant after 3 hours in the EEC. Ocular itching was graded on a 0-4 scale, where 0=none, 1=tickling sensation involving one or more corners of the eye, 2=all over tickling sensation; 3=moderate continuous itching with desire to rub; 4=severe itching with irresistible urge to rub.
• Change From Baseline in Patient-Assessed Ocular Itching, Conjunctival Allergen Provocation Test (CAPT), at 3 Hours [Baseline, 3 hours]: As assessed by the participant after 3 hours of CAPT. Ocular itching was graded on a 0-4 scale, where 0=none, 1=tickling sensation involving one or more corners of the eye, 2=all over tickling sensation; 3=moderate continuous itching with desire to rub; 4=severe itching with irresistible urge to rub.

Sex: All, ages: 18 Years to 65 Years

Inclusion Criteria:

* History of allergic conjunctivitis;
* Active signs and symptoms of ocular allergies;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* History of dry eye;
* Presence of ocular infection;
* Presence of severe or serious ocular conditions;
* Symptoms of allergic conjunctivitis;
* Use of topical or systemic ocular medications as specified in protocol;
* Ocular surgery or laser surgery within 6 months of study start;
* Unwilling to discontinue contact lens wear 72 hours prior to Visit 1 and during study period;
* Other protocol-defined exclusion criteria may apply.

Participant flow

Outcome results

• Change From Baseline in Patient-Assessed Ocular Itching, Environmental Exposure Chamber (EEC), at 3 Hours (Primary), Mean, Units on a scale: Patanol -1.63 +/- 0.6; Tears Naturale II -1.11 +/- 0.2
• Change From Baseline in Patient-Assessed Ocular Itching, Conjunctival Allergen Provocation Test (CAPT), at 3 Hours (Primary), Mean, Units on a scale: Patanol -0.38 +/- 0.6; Tears Naturale II -1.15 +/- 0.5

Adverse events

Time frame: Adverse events were collected for the duration of the study: 3 months, 1 week, 6 days.

Other adverse events by term

Limitations and caveats: This was a pilot study with a small number of subjects not adequately powered to detect treatment differences.