Assessing the Efficacy of Maxidex® and Patanol® for the Treatment of Allergic Conjunctivitis

Alcon

Status and phase: Completed; Phase 4

Conditions: Allergic Conjunctivitis

Treatments: Drug: Dexamethasone 0.1% ophthalmic suspension; Drug: Olopatadine hydrochloride 0.1% ophthalmic solution; Other: Inactive ingredients, used as placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01119287

C-10-002

Details and patient eligibility

About

The purpose of this study was to evaluate the efficacy of Maxidex and Patanol compared to placebo in patients with allergic conjunctivitis when exposed to controlled allergen levels in an Environmental Exposure Chamber (EEC).

Full description

This study consisted of 6 visits. Visit 1 was the Medical Screening Visit (skin prick test). Visit 2 and Visit 3 consisted of 2 consecutive EEC Visits (3 hours in the EEC followed by 7 hours in the Clinic, 10 hours total, each visit) followed by 7 days of wash-out. Visit 2 and Visit 3 occurred prior to dispense and the measures obtained during these visits were used as baseline. At Visit 4 patients were randomized and dispensed the assigned study medication for 7 days of at-home dosing. Visit 5 (Day 8 of treatment) and Visit 6 (Day 9 of treatment) consisted of 2 additional consecutive EEC Visits (3 hours in the EEC followed by 7 hours in the clinic, 10 hours total, each visit). During each EEC visit, patients were exposed to either ragweed or cat allergen, depending on their skin prick test results. Of the 180 participants enrolled, 170 received at least one dose of study treatment and were randomized to one of the three study treatments.

Enrollment: 180 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 1 year history of allergic conjunctivitis.
• Ability to self administer ophthalmic drops.
• Ability to avoid use of disallowed medications during the entire study period and specified period prior to visit 1.
• Other protocol-specified inclusion criteria may apply.

Exclusion criteria

• Presence of any ocular infection.
• Confirmed diagnosis of dry eye.
• Presence of glaucoma or ocular hypertension.
• Moderate to severe asthma.
• Any severe, unstable, or uncontrolled systemic disease.
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 3 patient groups, including a placebo group

Maxidex

Experimental group

Description:

Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days \[Visit 4 through Visit 6 morning only\]

Treatment:

Drug: Dexamethasone 0.1% ophthalmic suspension

Patanol

Experimental group

Description:

Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days \[Visit 4 through Visit 6 morning only\]

Treatment:

Drug: Olopatadine hydrochloride 0.1% ophthalmic solution

Tears Naturale II

Placebo Comparator group

Description:

Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days \[Visit 4 through Visit 6 morning only\]

Treatment:

Other: Inactive ingredients, used as placebo