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

Verified by: Vistakon Pharmaceuticals, September 2011
First Received: November 27, 2007 | Last Updated: September 26, 2011 | Phase: Phase 3 | Start Date: October 2007
Overall Status: Completed | Estimated Enrollment: 310
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The purpose of this study is to evaluate the safety of a novel contact lens in healthy normal...

Brief Summary

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: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
  • 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
    • contact lens without drug

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: K-lens
    • etafilcon A contact lens with ketotifen.
  • Placebo Comparator: Placebo
    • etafilcon A contact lens without ketotifen

Outcome Measures for this Clinical Trial

Primary Measures

  • Lid and Lid Margin Erythema, Change From Baseline
    • Time Frame: baseline and 12 weeks
      Safety Issue?: Yes
  • Lid and Lid Margin Swelling, Change From Baseline
    • Time Frame: baseline and 12 weeks
      Safety Issue?: Yes
  • Conjunctival Redness, Change From Baseline
    • Time Frame: baseline and 12 weeks
      Safety Issue?: Yes
  • Conjunctival Chemosis, Change From Baseline
    • Time Frame: baseline and 12 weeks
      Safety Issue?: Yes
  • Corneal Edema, Change From Baseline
    • Time Frame: baseline and 12 weeks
      Safety Issue?: Yes
  • Corneal Erosion, Change From Baseline
    • Time Frame: baseline and 12 weeks
      Safety Issue?: Yes
  • Corneal Endothelial, Change From Baseline
    • Time Frame: baseline and 12 weeks
      Safety Issue?: Yes
  • Lens Pathology, Change From Baseline
    • Time Frame: baseline and 12 weeks
      Safety Issue?: Yes
  • Flare in Anterior Chamber, Change From Baseline
    • Time Frame: baseline and 12 weeks
      Safety Issue?: Yes
  • Cells in Anterior Chamber, Change From Baseline
    • Time Frame: baseline and 12 weeks
      Safety Issue?: Yes
  • Corneal Staining - Nasal, Change From Baseline
    • Time Frame: baseline and 12 weeks
      Safety Issue?: Yes
  • Corneal Staining - Temporal, Change From Baseline
    • Time Frame: baseline and 12 weeks
      Safety Issue?: Yes
  • Corneal Staining - Inferior, Change From Baseline
    • Time Frame: baseline and 12 weeks
      Safety Issue?: Yes
  • Corneal Staining - Superior, Change From Baseline
    • Time Frame: baseline and 12 weeks
      Safety Issue?: Yes
  • Corneal Staining - Central, Change From Baseline
    • Time Frame: baseline and 12 weeks
      Safety Issue?: Yes
  • Intraocular Pressure, Change From Baseline
    • Time Frame: baseline and 12 weeks
      Safety Issue?: Yes
  • Dilated Ophthalmoscopy - Fundus, Change From Baseline
    • Time Frame: baseline and 12 weeks
      Safety Issue?: Yes
  • Dilated Ophthalmoscopy - Vitreous, Change From Baseline
    • Time Frame: baseline and 12 weeks
      Safety Issue?: Yes
  • Visual Acuity Assessment
    • Time Frame: at 12 weeks
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Clinical Trial Investigator Information

Lead Investigator: Vistakon Pharmaceuticals Industry

Overall Clinical Trial Officials and Contacts

Brian Pall, OD, MS, FAAO Study Director Vistakon  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

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

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00569777