Safety and Comfort of AL-4943A Ophthalmic Solution

Alcon

Status and phase: Completed; Phase 1

Conditions: Allergic Conjunctivitis

Treatments: Drug: Ketotifen fumarate ophthalmic solution, 0.025%; Drug: Olopatadine hydrochloride ophthalmic solution, 0.7%; Drug: Olopatadine hydrochloride ophthalmic solution vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT01326858

C-10-127

Details and patient eligibility

About

The purpose of this study is to assess the ocular comfort and safety of olopatadine hydrochloride opthalmic solution. 0.7%.

Full description

In this 3-treatment, 3-period, 6-sequence crossover study, each subject will receive all 3 products in randomized order, 1 product at a time, with a washout period of 24 hours between treatment periods. Following instillation of study medication, subjects will complete a 3-minute discomfort profile.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Able to be dosed in both eyes, to follow instructions, and willing and able to attend required study visits.
• Negative urine pregnancy test if female of childbearing potential and use adequate birth control throughout the study period.
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• History or clinical evidence of ocular herpes simplex or ocular herpes zoster infectious disease.
• History of any clinically significant external ocular disease within 30 days of the start of the study.
• Presence of active blepharitis, active meibomian gland dysfunction, active rosacea affecting the ocular surface/lid margin, active or chronic follicular conjunctivitis, preauricular adenopathy, or any other ocular or periocular abnormality that may affect the study outcomes.
• Other protocol-defined exclusion criteria may apply.

Trial design

50 participants in 3 patient groups, including a placebo group

Olopatadine, 0.7%

Experimental group

Description:

Olopatadine hydrochloride ophthalmic solution, 0.7%, 1 drop instilled in each eye, 1 dose, in Period 1, followed by olopatadine hydrochloride ophthalmic vehicle and ketotifen fumarate ophthalmic solution, 0.025%, Periods 2 and 3, as randomized

Treatment:

Drug: Olopatadine hydrochloride ophthalmic solution vehicle

Drug: Olopatadine hydrochloride ophthalmic solution, 0.7%

Drug: Ketotifen fumarate ophthalmic solution, 0.025%

Vehicle

Placebo Comparator group

Description:

Olopatadine hydrochloride ophthalmic solution vehicle, 1 drop instilled in each eye, 1 dose, in Period 1, followed by olopatadine hydrochloride ophthalmic solution, 0.7% and ketotifen fumarate ophthalmic solution, 0.025%, Periods 2 and 3, as randomized

Treatment:

Drug: Olopatadine hydrochloride ophthalmic solution vehicle

Drug: Olopatadine hydrochloride ophthalmic solution, 0.7%

Drug: Ketotifen fumarate ophthalmic solution, 0.025%

Zaditor

Active Comparator group

Description:

Ketotifen fumarate ophthalmic solution, 0.025%, 1 drop instilled in each eye, 1 dose, in Period 1, followed by olopatadine hydrochloride ophthalmic solution, 0.7% and olopatadine hydrochloride ophthalmic solution vehicle, Periods 2 and 3, as randomized

Treatment:

Drug: Olopatadine hydrochloride ophthalmic solution vehicle

Drug: Olopatadine hydrochloride ophthalmic solution, 0.7%

Drug: Ketotifen fumarate ophthalmic solution, 0.025%