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

Primary Purpose

Allergic Conjunctivitis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
K-Lens (generic name not established) and Ketotifen
Placebo Lens
Sponsored by
Vistakon Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Allergic Conjunctivitis

Eligibility Criteria

8 Years - undefined (Child, Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

K-lens

Placebo

Arm Description

etafilcon A contact lens with ketotifen.

etafilcon A contact lens without ketotifen

Outcomes

Primary Outcome Measures

Lid and Lid Margin Erythema, Change From Baseline
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
Assessment of lid swelling using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
Conjunctival Redness, Change From Baseline
Assessment of redness of conjunctiva using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
Conjunctival Chemosis, Change From Baseline
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
Assessment of corneal swelling using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
Corneal Erosion, Change From Baseline
Assessment of corneal erosion using the following scale: 0=none, 1=mild, 2=moderate, 3=severe.
Corneal Endothelial, Change From Baseline
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
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
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
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
Assessment of changes to the surface of 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
Assessment of changes to the surface of the cornea, the region towards the outer 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
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
Assessment of changes to the surface of the cornea, 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
Assessment of changes to the surface of the cornea, 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
Dilated Ophthalmoscopy - Fundus, Change From Baseline
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
Assessment of changes in the vitreous (gel-like fluid of the eye), using the scale: 0=none, 0.5=trace, 1=mild, 2=moderate, 3=severe.
Visual Acuity Assessment
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.

Secondary Outcome Measures

Full Information

First Posted
November 27, 2007
Last Updated
February 18, 2015
Sponsor
Vistakon Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00569777
Brief Title
Safety Study of a Contact Lens With Ketotifen in Healthy, Normal Volunteers
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vistakon Pharmaceuticals

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Conjunctivitis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
310 (Actual)

8. Arms, Groups, and Interventions

Arm Title
K-lens
Arm Type
Experimental
Arm Description
etafilcon A contact lens with ketotifen.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
etafilcon A contact lens without ketotifen
Intervention Type
Device
Intervention Name(s)
K-Lens (generic name not established) and Ketotifen
Intervention Description
combination drug-device product: contact lens (device) and anti-allergy drug
Intervention Type
Device
Intervention Name(s)
Placebo Lens
Intervention Description
contact lens without drug
Primary Outcome Measure Information:
Title
Lid and Lid Margin Erythema, Change From Baseline
Description
Assessment of lid redness using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
Time Frame
baseline and 12 weeks
Title
Lid and Lid Margin Swelling, Change From Baseline
Description
Assessment of lid swelling using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
Time Frame
baseline and 12 weeks
Title
Conjunctival Redness, Change From Baseline
Description
Assessment of redness of conjunctiva using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
Time Frame
baseline and 12 weeks
Title
Conjunctival Chemosis, Change From Baseline
Description
Assessment of swelling of the conjunctiva using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
Time Frame
baseline and 12 weeks
Title
Corneal Edema, Change From Baseline
Description
Assessment of corneal swelling using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
Time Frame
baseline and 12 weeks
Title
Corneal Erosion, Change From Baseline
Description
Assessment of corneal erosion using the following scale: 0=none, 1=mild, 2=moderate, 3=severe.
Time Frame
baseline and 12 weeks
Title
Corneal Endothelial, Change From Baseline
Description
Assessment of the posterior cornea using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
Time Frame
baseline and 12 weeks
Title
Lens Pathology, Change From Baseline
Description
Assessment of the clarity of the intraocular lens using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
Time Frame
baseline and 12 weeks
Title
Flare in Anterior Chamber, Change From Baseline
Description
Assessment of visible protein in the anterior chamber using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
Time Frame
baseline and 12 weeks
Title
Cells in Anterior Chamber, Change From Baseline
Description
Assessment of visible cells in the anterior chamber using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
Time Frame
baseline and 12 weeks
Title
Corneal Staining - Nasal, Change From Baseline
Description
Assessment of changes to the surface of 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.
Time Frame
baseline and 12 weeks
Title
Corneal Staining - Temporal, Change From Baseline
Description
Assessment of changes to the surface of the cornea, the region towards the outer 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.
Time Frame
baseline and 12 weeks
Title
Corneal Staining - Inferior, Change From Baseline
Description
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.
Time Frame
baseline and 12 weeks
Title
Corneal Staining - Superior, Change From Baseline
Description
Assessment of changes to the surface of the cornea, 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.
Time Frame
baseline and 12 weeks
Title
Corneal Staining - Central, Change From Baseline
Description
Assessment of changes to the surface of the cornea, 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.
Time Frame
baseline and 12 weeks
Title
Intraocular Pressure, Change From Baseline
Time Frame
baseline and 12 weeks
Title
Dilated Ophthalmoscopy - Fundus, Change From Baseline
Description
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.
Time Frame
baseline and 12 weeks
Title
Dilated Ophthalmoscopy - Vitreous, Change From Baseline
Description
Assessment of changes in the vitreous (gel-like fluid of the eye), using the scale: 0=none, 0.5=trace, 1=mild, 2=moderate, 3=severe.
Time Frame
baseline and 12 weeks
Title
Visual Acuity Assessment
Description
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.
Time Frame
at 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Pall, OD, MS, FAAO
Organizational Affiliation
Johnson & Johnson Vision Care, Inc.
Official's Role
Study Director
Facility Information:
City
Gardena
State/Province
California
ZIP/Postal Code
90247
Country
United States
City
North Andover
State/Province
Massachusetts
ZIP/Postal Code
01845
Country
United States
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States

12. IPD Sharing Statement

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

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