Official Title: “A Multi-Center, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Study Evaluating the Safety of a Novel Contact Lens Used Daily in Healthy, Normal Volunteers”

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

Study Type: Interventional

Study Design: Basic Science, Randomized, Double Blind (Subject, Investigator), Parallel Assignment

Study Primary Completion Date: February 2008

Intervention(s) in this Clinical Trial

• Device: K-Lens (generic name not established) and Ketotifen
  • combination drug-device product: contact lens (device) and anti-allergy drug
• Device: Placebo Lens
  • Placebo Lens

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • K-Lens
• Placebo Comparator: 2
  • Placebo lens

Primary Measures

• Adverse events, biomicroscopy, visual acuity, ophthalmoscopy and intraocular pressure, physical exam, pupil reactivity
  • Time Frame: 12 weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 8 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Vistakon Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Brian Pall, OD, MS, FAAO Study Director Vistakon  

Information obtained from ClinicalTrials.gov on January 08, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00569777

Study ID Number: 07-003-002

ClinicalTrials.gov Identifier: NCT00569777

Health Authority: United States: Food and Drug Administration