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

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: July 2009

Interventions

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

Arms, Groups and Cohorts

  • Experimental: K-Lens
    • Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
  • Placebo Comparator: Placebo Lens
    • Placebo lens

Clinical Trial Outcome Measures

Primary Measures

  • Lid and Lid Margin Erythema, Change From Baseline
    • Time Frame: baseline and 12 weeks
    • Assessment of lid redness using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe
  • Lid and Lid Margin Swelling, Change From Baseline
    • Time Frame: baseline and 12 weeks
    • Assessment of lid swelling using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe
  • Conjunctival Redness, Change From Baseline
    • Time Frame: baseline and 12 weeks
    • Assessment of conjunctival redness using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe
  • Conjunctival Chemosis, Change From Baseline
    • Time Frame: baseline and 12 weeks
    • Assessment of swelling of the conjunctiva using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe
  • Corneal Edema, Change From Baseline
    • Time Frame: baseline and 12 weeks
    • Assessment of corneal swelling using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe
  • Corneal Erosion, Change From Baseline
    • Time Frame: baseline and 12 weeks
    • Assessment of corneal erosion using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe
  • Corneal Endothelial, Change From Baseline
    • Time Frame: baseline and 12 weeks
    • Assessment of the posterior cornea using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe
  • Lens Pathology, Change From Baseline
    • Time Frame: baseline and 12 weeks
    • Assessment of the clarity of the intraocular lens using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe
  • Flare in Anterior Chamber, Change From Baseline
    • Time Frame: baseline and 12 weeks
    • Assessment of visible protein in the anterior chamber using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe
  • Cells in Anterior Chamber, Change From Baseline
    • Time Frame: baseline and 12 weeks
    • Assessment of visible cells in the anterior chamber using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe
  • Corneal Staining – Nasal, Change From Baseline
    • Time Frame: baseline and 12 weeks
    • Assessment of changes to the surface of the cornea, the region towards the nose, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe
  • Corneal Staining – Temporal, Change From Baseline
    • Time Frame: baseline and 12 weeks
    • Assessment of changes to the surface of the cornea, the region towards the edge of the face, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe
  • Corneal Staining – Inferior, Change From Baseline
    • Time Frame: baseline and 12 weeks
    • Assessment of changes to the surface of the cornea, the bottom region, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe
  • Corneal Staining – Superior, Change From Baseline
    • Time Frame: baseline and 12 weeks
    • Assessment of changes to the surface of the cornea, the upper region, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe
  • Corneal Staining – Central, Change From Baseline
    • Time Frame: baseline and 12 weeks
    • Assessment of changes to the surface of the cornea, the central region, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe
  • Intraocular Pressure – Change From Baseline
    • Time Frame: baseline and 12 weeks
  • Dilated Ophthalmoscopy – Fundus, Change From Baseline
    • Time Frame: baseline and 12 weeks
    • Assessment of changes in abnormalities on the back part of the eye, using the scale: 0=none, 0.5=trace, 1=mild, 2=moderate, 3=severe.
  • Dilated Ophthalmoscopy – Vitreous, Change From Baseline
    • Time Frame: baseline and 12 weeks
    • Assessment of changes in the vitreous (gel-like fulid of the eye), using the scale: 0=none, 0.5=trace, 1=mild, 2=moderate, 3=severe.
  • Visual Acuity Assessment
    • Time Frame: at the 12 week visit
    • Visual acuity was assessed by the investigator using a Snellen visual acuity chart. This outcome counts the number of eyes that had vision of 20/40 or better at the 12 week visit.

Participating 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: All

Minimum Age: 8 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Vistakon Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Brian Pall, OD, MS, FAAO, Study Director, Johnson & Johnson Vision Care, Inc.

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