AL-38583 Ophthalmic Solution for Allergic Conjunctivitis Associated Inflammation

Alcon

Status and phase: Completed; Phase 2

Conditions: Allergic Conjunctivitis

Treatments: Drug: Dexamethasone ophthalmic suspension, 0.1%; Drug: AL-38583 ophthalmic solution; Drug: AL-38583 ophthalmic solution vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT01001091

C-09-034

Details and patient eligibility

About

The purpose of this study is to assess the safety and efficacy of AL-38583 in the treatment of the signs of inflammation associated with allergic conjunctivitis.

Enrollment: 312 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Presence of signs and symptoms of ocular inflammation in both eyes.
• Have a positive CAC response at Visit 1.
• Able to avoid the use of disallowed medications as well as contact lens wear for the specified period prior to Visit 1, and for the duration of the study.
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Have known history or presence of persistent dry eye syndrome.
• Presence of any ophthalmic abnormality that may affect the study outcomes.
• Have a history of moderate to severe allergic asthma reaction to mountain cedar or the perennial allergens used in the study.
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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312 participants in 5 patient groups, including a placebo group

AL-38583 0.01%

Experimental group

Description:

AL-38583 ophthalmic solution, 1 drop instilled in each eye 3 times per day for 2 weeks

Treatment:

Drug: AL-38583 ophthalmic solution

AL-38583 0.05%

Experimental group

Description:

AL-38583 ophthalmic solution, 1 drop instilled in each eye 3 times per day for 2 weeks

Treatment:

Drug: AL-38583 ophthalmic solution

AL-38583 0.2%

Experimental group

Description:

AL-38583 ophthalmic solution, 1 drop instilled in each eye 3 times per day for 2 weeks

Treatment:

Drug: AL-38583 ophthalmic solution

AL-38583 Vehicle

Placebo Comparator group

Description:

AL-38583 ophthalmic solution vehicle, 1 drop instilled in each eye 3 times per day for 2 weeks

Treatment:

Drug: AL-38583 ophthalmic solution vehicle

MAXIDEX

Active Comparator group

Description:

Dexamethasone ophthalmic suspension, 0.1%, 1 drop instilled in each eye 3 times per day for 2 weeks

Treatment:

Drug: Dexamethasone ophthalmic suspension, 0.1%