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: Placebo Lens; Device: K-Lens (generic name not established) and Ketotifen

Study type: Interventional

Funder types: Industry

Identifiers

NCT00569777

07-003-002

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: 310 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: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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310 participants in 2 patient groups, including a placebo group

K-lens

Experimental group

Description:

etafilcon A contact lens with ketotifen.

Treatment:

Device: K-Lens (generic name not established) and Ketotifen

Placebo

Placebo Comparator group

Description:

etafilcon A contact lens without ketotifen

Treatment:

Device: Placebo Lens