Assessment of Alcon's Ocular Image Quantification System

Alcon

Status and phase: Completed; Phase 4

Conditions: Allergic Conjunctivitis

Treatments: Other: Dextran 70 0.1%, hydroxypropyl methylcellulose 0.3% (Tears Naturale II); Drug: Olopatadine hydrochloride, 0.1% ophthalmic solution (Patanol)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01282138

RDG-10-278

Details and patient eligibility

About

The purpose of this study was to evaluate ocular responses with different allergen provocation methods.

Full description

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.

Enrollment: 13 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

13 participants in 2 patient groups, including a placebo group

Patanol

Experimental group

Description:

One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.

Treatment:

Drug: Olopatadine hydrochloride, 0.1% ophthalmic solution (Patanol)

Tears Naturale II

Placebo Comparator group

Description:

One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.

Treatment:

Other: Dextran 70 0.1%, hydroxypropyl methylcellulose 0.3% (Tears Naturale II)