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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
contact lens with ketotifen
contact lens
Sponsored by
Vistakon Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment 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 Lens

Arm Description

Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug

Placebo lens

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 conjunctival redness 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, 4=very 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 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
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
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, 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
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
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 fulid 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
April 24, 2009
Last Updated
February 18, 2015
Sponsor
Vistakon Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00889252
Brief Title
Safety Study of a Contact Lens With Ketotifen in Healthy, Normal Volunteers
Official Title
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
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

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
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
K-Lens
Arm Type
Experimental
Arm Description
Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
Arm Title
Placebo Lens
Arm Type
Placebo Comparator
Arm Description
Placebo lens
Intervention Type
Device
Intervention Name(s)
contact lens with ketotifen
Intervention Description
K-Lens (generic name not established) and Ketotifen combination drug-device product
Intervention Type
Device
Intervention Name(s)
contact lens
Intervention Description
Placebo contact lens
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 conjunctival redness 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, 4=very 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 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
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 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, 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
Time Frame
baseline and 12 weeks
Title
Corneal Staining - Central, Change From Baseline
Description
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
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 fulid 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 the 12 week visit

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
Memphis
State/Province
Tennessee
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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