Safety Study of a Contact Lens With Ketotifen in Healthy, Normal Volunteers

Vistakon Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Allergic Conjunctivitis

Treatments: Device: contact lens; Device: contact lens with ketotifen

Study type: Interventional

Funder types: Industry

Identifiers

NCT00889252

CR-4539

Details and patient eligibility

About

The purpose of this study is to evaluate the safety of a novel contact lens in healthy normal volunteers.

Enrollment: 250 patients

Sex: All

Ages: 8+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy normal, soft contact lens wearing volunteers
• normal ocular health
• contact lens correction from +6.00 to -12.00D in each eye and astigmatism of -1.00D or less in each eye

Exclusion criteria

• active ocular infection
• history of ocular surgery
• use of topical ophthalmic preparations (including rewetting drops)
• pregnancy or lactation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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250 participants in 2 patient groups, including a placebo group

K-Lens

Experimental group

Description:

Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug

Treatment:

Device: contact lens with ketotifen

Placebo Lens

Placebo Comparator group

Description:

Placebo lens

Treatment:

Device: contact lens