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Clinical Performance of Atypical Contact Lens Powers on Subjects With Astigmatism

Primary Purpose

Astigmatism

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
senofilcon A toric
galyfilcon A toric
Sponsored by
Johnson & Johnson Vision Care, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Astigmatism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Able to wear study lenses in parameters available.
  • At least 18
  • understand and sign informed consent
  • willing to follow the protocol
  • achieve at least 6/9 Visual Acuity (VA), both eyes (OU) with study lenses
  • hyperopes: +2.00 to +4.00 with -0.75 D cylinder around 180, high myopes: -6.00 to -8.00 with -1.25 D cylinder around 180
  • oblique axis: -2.00 to -4.00 with -0.75 D cyl around 45 or 135, have worn Soft Contact Lenses's within last 6 months

Exclusion Criteria:

  • Any ocular or systemic disorder which may contraindicate Contact Lens (CL) wear
  • any topical ocular medication
  • aphakic
  • corneal refractive surgery,
  • corneal distortion from hard CL wear or keratoconus
  • pregnant or lactating
  • grade 2 or worse slit lamp signs
  • infectious disease
  • previous clinical study within 2 weeks
  • don't agree to participate

Sites / Locations

  • Eurolens Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

senofilcon A/galyfilcon A

galyfilcon A/senofilcon A

Arm Description

senofilcon A silicone hydrogel toric contact lenses will be worn first. galyfilcon A silicone hydrogel toric contact lenses will be worn second.

galyfilcon A silicone hydrogel toric contact lenses worn first. senofilcon A silicone hydrogel toric contact lenses worn second.

Outcomes

Primary Outcome Measures

Assessment of Conjunctival Hyperemia in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)
Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Assessment of Conjunctival Hyperemia in Subjects That Are Hyperopes (Farsighted)
Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Assessment of Conjunctival Hyperemia in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)
Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Assessment of Limbal Hyperemia in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)
Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Assessment of Limbal Hyperemia in Subjects That Are Hyperopes (Farsighted)
Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Assessment of Limbal Hyperemia in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)
Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Assessment of Corneal Staining in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)
Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Assessment of Corneal Staining in Subjects That Are Hyperopes (Farsighted)
Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Assessment of Corneal Staining in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)
Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Assessment of Conjunctival Staining in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)
Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Assessment of Conjunctival Staining in Subjects That Are Hyperopes (Farsighted)
Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Assessment of Conjunctival Staining in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)
Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Assessment of Papillary Conjunctivitis in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)
Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Assessment of Papillary Conjunctivitis in Subjects That Are Hyperopes (Farsighted)
Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Assessment of Papillary Conjunctivitis in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)
Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.

Secondary Outcome Measures

Full Information

First Posted
June 10, 2008
Last Updated
May 6, 2015
Sponsor
Johnson & Johnson Vision Care, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00697190
Brief Title
Clinical Performance of Atypical Contact Lens Powers on Subjects With Astigmatism
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Vision Care, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate the fitting characteristics and physiological response of two toric lenses manufactured by Vistakon.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
senofilcon A/galyfilcon A
Arm Type
Active Comparator
Arm Description
senofilcon A silicone hydrogel toric contact lenses will be worn first. galyfilcon A silicone hydrogel toric contact lenses will be worn second.
Arm Title
galyfilcon A/senofilcon A
Arm Type
Active Comparator
Arm Description
galyfilcon A silicone hydrogel toric contact lenses worn first. senofilcon A silicone hydrogel toric contact lenses worn second.
Intervention Type
Device
Intervention Name(s)
senofilcon A toric
Other Intervention Name(s)
Acuvue Oasys for Astigmatism
Intervention Description
silicone hydrogel contact lens for patients with astigmatism
Intervention Type
Device
Intervention Name(s)
galyfilcon A toric
Other Intervention Name(s)
Acuvue Advance for Astigmatism
Intervention Description
silicone hydrogel contact lens for patients with astigmatism
Primary Outcome Measure Information:
Title
Assessment of Conjunctival Hyperemia in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)
Description
Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Time Frame
after 6 hours of wear
Title
Assessment of Conjunctival Hyperemia in Subjects That Are Hyperopes (Farsighted)
Description
Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Time Frame
after 6 hours of wear
Title
Assessment of Conjunctival Hyperemia in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)
Description
Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Time Frame
after 6 hours of wear
Title
Assessment of Limbal Hyperemia in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)
Description
Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Time Frame
after 6 hours of wear
Title
Assessment of Limbal Hyperemia in Subjects That Are Hyperopes (Farsighted)
Description
Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Time Frame
after 6 hours of wear
Title
Assessment of Limbal Hyperemia in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)
Description
Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Time Frame
after 6 hours of wear
Title
Assessment of Corneal Staining in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)
Description
Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Time Frame
after 6 hours of wear
Title
Assessment of Corneal Staining in Subjects That Are Hyperopes (Farsighted)
Description
Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Time Frame
after 6 hours of wear
Title
Assessment of Corneal Staining in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)
Description
Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Time Frame
after 6 hours of wear
Title
Assessment of Conjunctival Staining in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)
Description
Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Time Frame
after 6 hours of wear
Title
Assessment of Conjunctival Staining in Subjects That Are Hyperopes (Farsighted)
Description
Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Time Frame
after 6 hours of wear
Title
Assessment of Conjunctival Staining in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)
Description
Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Time Frame
after 6 hours of wear
Title
Assessment of Papillary Conjunctivitis in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)
Description
Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Time Frame
after 6 hours of wear
Title
Assessment of Papillary Conjunctivitis in Subjects That Are Hyperopes (Farsighted)
Description
Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Time Frame
after 6 hours of wear
Title
Assessment of Papillary Conjunctivitis in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)
Description
Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Time Frame
after 6 hours of wear

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Able to wear study lenses in parameters available. At least 18 understand and sign informed consent willing to follow the protocol achieve at least 6/9 Visual Acuity (VA), both eyes (OU) with study lenses hyperopes: +2.00 to +4.00 with -0.75 D cylinder around 180, high myopes: -6.00 to -8.00 with -1.25 D cylinder around 180 oblique axis: -2.00 to -4.00 with -0.75 D cyl around 45 or 135, have worn Soft Contact Lenses's within last 6 months Exclusion Criteria: Any ocular or systemic disorder which may contraindicate Contact Lens (CL) wear any topical ocular medication aphakic corneal refractive surgery, corneal distortion from hard CL wear or keratoconus pregnant or lactating grade 2 or worse slit lamp signs infectious disease previous clinical study within 2 weeks don't agree to participate
Facility Information:
Facility Name
Eurolens Research
City
Manchester
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Clinical Performance of Atypical Contact Lens Powers on Subjects With Astigmatism

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