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Comparison of Lens Fit and Lens Power of a New Contact Lens to Two Marketed Contact Lenses in a Population of Soft Contact Lens Wearers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT01244529
First received: November 17, 2010
Last updated: December 19, 2011
Last verified: December 2011
History of Changes
  Purpose

The purpose of this study is to evaluate the comparability of lens fit and lens power of a new contact lens to the lens fit and lens power of two marketed lenses.


Condition Intervention
Myopia
 Device: galyfilcon AP 8.3 BC
Device: galyfilcon AP 8.7 BC
Device: galyfilcon A 8.3 BC
Device: galyfilcon A 8.7 BC
Device: senofilcon A 8.4 BC
Device: senofilcon A 8.8 BC

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Further study details as provided by Vistakon:

Primary Outcome Measures:
  • Lens Centration [ Time Frame: after 15 minutes of contact lens wear ] [ Designated as safety issue: No ]
    Investigator evaluated as acceptable or unacceptable. Percent of eyes in each category will be evaluated.

  • Primary Gaze Lens Movement [ Time Frame: after 15 minutes of contact lens wear ] [ Designated as safety issue: No ]
    Investigator evaluated as acceptable or unacceptable. Percent of eyes in each category will be evaluated.

  • Fit Acceptability [ Time Frame: after 15 minutes of contact lens wear ] [ Designated as safety issue: No ]
    Investigator evaluated as acceptable or unacceptable. Percent of eyes in each category will be evaluated.


Secondary Outcome Measures:
  • New Lens Power Fit Match to Control Lenses [ Time Frame: after 15 minutes of contact lens wear ] [ Designated as safety issue: No ]
    The lens power fit of test lenses will be compared to control lenses to determine if the power matches. Percent of eyes with exact power fit will be evaluated.


Enrollment: 41
Study Start Date: September 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
galyP 8.3/8.7;galy 8.3/8.7;seno 8.4/8.8

Pair 1: galyfilcon AP soft contact lens with 8.3 base curve worn in the right eye and galyfilcon AP soft contact lens with 8.7 base curve worn in the left eye.

Pair 2: galyfilcon A soft contact lens with 8.3 base curve worn in the right eye and galyfilcon A soft contact lens with 8.7 base curve worn in the left eye.

Pair 3: senofilcon A soft contact lens with 8.4 base curve worn in the right eye and senofilcon A soft contact lens with 8.8 base curve worn in the left eye.

 Device: galyfilcon AP 8.3 BC
galyfilcon AP 8.3 BC soft contact lens
Device: galyfilcon AP 8.7 BC
galyfilcon AP 8.7 BC soft contact lens
Device: galyfilcon A 8.3 BC
galyfilcon A 8.3 BC soft contact lens
Device: galyfilcon A 8.7 BC
galyfilcon A 8.7 BC soft contact lens
Device: senofilcon A 8.4 BC
senofilcon A 8.4 BC soft contact lens
Device: senofilcon A 8.8 BC
senofilcon A 8.8 BC soft contact lens
galyP 8.3/8.7;seno 8.4/8.8;galy 8.3/8.7

Pair 1: galyfilcon AP soft contact lens with 8.3 base curve worn in the right eye and galyfilcon AP soft contact lens with 8.7 base curve worn in the left eye.

Pair 2: senofilcon A soft contact lens with 8.4 base curve worn in the right eye and senofilcon A soft contact lens with 8.8 base curve worn in the left eye.

Pair 3: galyfilcon A soft contact lens with 8.3 base curve worn in the right eye and galyfilcon A soft contact lens with 8.7 base curve worn in the left eye.

 Device: galyfilcon AP 8.3 BC
galyfilcon AP 8.3 BC soft contact lens
Device: galyfilcon AP 8.7 BC
galyfilcon AP 8.7 BC soft contact lens
Device: galyfilcon A 8.3 BC
galyfilcon A 8.3 BC soft contact lens
Device: galyfilcon A 8.7 BC
galyfilcon A 8.7 BC soft contact lens
Device: senofilcon A 8.4 BC
senofilcon A 8.4 BC soft contact lens
Device: senofilcon A 8.8 BC
senofilcon A 8.8 BC soft contact lens
galyP 8.7/8.3;galy 8.7/8.3;seno 8.8/8.4

Pair 1: galyfilcon AP soft contact lens with 8.7 base curve worn in the right eye and galyfilcon AP soft contact lens with 8.3 base curve worn in the left eye.

Pair 2: galyfilcon A soft contact lens with 8.7 base curve worn in the right eye and galyfilcon A soft contact lens with 8.3 base curve worn in the left eye.

Pair 3: senofilcon A soft contact lens with 8.8 base curve worn in the right eye and senofilcon A soft contact lens with 8.4 base curve worn in the left eye.

 Device: galyfilcon AP 8.3 BC
galyfilcon AP 8.3 BC soft contact lens
Device: galyfilcon AP 8.7 BC
galyfilcon AP 8.7 BC soft contact lens
Device: galyfilcon A 8.3 BC
galyfilcon A 8.3 BC soft contact lens
Device: galyfilcon A 8.7 BC
galyfilcon A 8.7 BC soft contact lens
Device: senofilcon A 8.4 BC
senofilcon A 8.4 BC soft contact lens
Device: senofilcon A 8.8 BC
senofilcon A 8.8 BC soft contact lens
galyP 8.7/8.3;seno 8.8/8.4;galy 8.7/8.3

Pair 1: galyfilcon AP soft contact lens with 8.7 base curve worn in the right eye and galyfilcon AP soft contact lens with 8.3 base curve worn in the left eye.

Pair 2: senofilcon A soft contact lens with 8.8 base curve worn in the right eye and senofilcon A soft contact lens with 8.4 base curve worn in the left eye.

Pair 3: galyfilcon A soft contact lens with 8.7 base curve worn in the right eye and galyfilcon A soft contact lens with 8.3 base curve worn in the left eye.

 Device: galyfilcon AP 8.3 BC
galyfilcon AP 8.3 BC soft contact lens
Device: galyfilcon AP 8.7 BC
galyfilcon AP 8.7 BC soft contact lens
Device: galyfilcon A 8.3 BC
galyfilcon A 8.3 BC soft contact lens
Device: galyfilcon A 8.7 BC
galyfilcon A 8.7 BC soft contact lens
Device: senofilcon A 8.4 BC
senofilcon A 8.4 BC soft contact lens
Device: senofilcon A 8.8 BC
senofilcon A 8.8 BC soft contact lens
galy 8.3/8.7;galyP 8.3/8.7;seno 8.4/8.8

Pair 1: galyfilcon A soft contact lens with 8.3 base curve worn in the right eye and galyfilcon A soft contact lens with 8.7 base curve worn in the left eye.

Pair 2: galyfilcon AP soft contact lens with 8.3 base curve worn in the right eye and galyfilcon AP soft contact lens with 8.7 base curve worn in the left eye.

Pair 3: senofilcon A soft contact lens with 8.4 base curve worn in the right eye and senofilcon A soft contact lens with 8.8 base curve worn in the left eye.

 Device: galyfilcon AP 8.3 BC
galyfilcon AP 8.3 BC soft contact lens
Device: galyfilcon AP 8.7 BC
galyfilcon AP 8.7 BC soft contact lens
Device: galyfilcon A 8.3 BC
galyfilcon A 8.3 BC soft contact lens
Device: galyfilcon A 8.7 BC
galyfilcon A 8.7 BC soft contact lens
Device: senofilcon A 8.4 BC
senofilcon A 8.4 BC soft contact lens
Device: senofilcon A 8.8 BC
senofilcon A 8.8 BC soft contact lens
galy 8.3/8.7;seno 8.4/8.8;galyP 8.3/8.7

Pair 1: galyfilcon A soft contact lens with 8.3 base curve worn in the right eye and galyfilcon A soft contact lens with 8.7 base curve worn in the left eye.

Pair 2: senofilcon A soft contact lens with 8.4 base curve worn in the right eye and senofilcon A soft contact lens with 8.8 base curve worn in the left eye.

Pair 3: galyfilcon AP soft contact lens with 8.3 base curve worn in the right eye and galyfilcon AP soft contact lens with 8.7 base curve worn in the left eye.

 Device: galyfilcon AP 8.3 BC
galyfilcon AP 8.3 BC soft contact lens
Device: galyfilcon AP 8.7 BC
galyfilcon AP 8.7 BC soft contact lens
Device: galyfilcon A 8.3 BC
galyfilcon A 8.3 BC soft contact lens
Device: galyfilcon A 8.7 BC
galyfilcon A 8.7 BC soft contact lens
Device: senofilcon A 8.4 BC
senofilcon A 8.4 BC soft contact lens
Device: senofilcon A 8.8 BC
senofilcon A 8.8 BC soft contact lens
galy 8.7/8.3;galyP 8.7/8.3;seno 8.8/8.4

Pair 1: galyfilcon A soft contact lens with 8.7 base curve worn in the right eye and galyfilcon A soft contact lens with 8.3 base curve worn in the left eye.

Pair 2: galyfilcon AP soft contact lens with 8.7 base curve worn in the right eye and galyfilcon AP soft contact lens with 8.3 base curve worn in the left eye.

Pair 3: senofilcon A soft contact lens with 8.8 base curve worn in the right eye and senofilcon A soft contact lens with 8.4 base curve worn in the left eye.

 Device: galyfilcon AP 8.3 BC
galyfilcon AP 8.3 BC soft contact lens
Device: galyfilcon AP 8.7 BC
galyfilcon AP 8.7 BC soft contact lens
Device: galyfilcon A 8.3 BC
galyfilcon A 8.3 BC soft contact lens
Device: galyfilcon A 8.7 BC
galyfilcon A 8.7 BC soft contact lens
Device: senofilcon A 8.4 BC
senofilcon A 8.4 BC soft contact lens
Device: senofilcon A 8.8 BC
senofilcon A 8.8 BC soft contact lens
galy 8.7/8.3;seno 8.8/8.4;galyP 8.7/8.3

Pair 1: galyfilcon A soft contact lens with 8.7 base curve worn in the right eye and galyfilcon A soft contact lens with 8.3 base curve worn in the left eye.

Pair 2: senofilcon A soft contact lens with 8.8 base curve worn in the right eye and senofilcon A soft contact lens with 8.4 base curve worn in the left eye.

Pair 3: galyfilcon AP soft contact lens with 8.7 base curve worn in the right eye and galyfilcon AP soft contact lens with 8.3 base curve worn in the left eye.

 Device: galyfilcon AP 8.3 BC
galyfilcon AP 8.3 BC soft contact lens
Device: galyfilcon AP 8.7 BC
galyfilcon AP 8.7 BC soft contact lens
Device: galyfilcon A 8.3 BC
galyfilcon A 8.3 BC soft contact lens
Device: galyfilcon A 8.7 BC
galyfilcon A 8.7 BC soft contact lens
Device: senofilcon A 8.4 BC
senofilcon A 8.4 BC soft contact lens
Device: senofilcon A 8.8 BC
senofilcon A 8.8 BC soft contact lens
seno 8.4/8.8;galyP 8.3/8.7;galy 8.3/8.7

Pair 1: senofilcon A soft contact lens with 8.4 base curve worn in the right eye and senofilcon A soft contact lens with 8.8 base curve worn in the left eye.

Pair 2: galyfilcon AP soft contact lens with 8.3 base curve worn in the right eye and galyfilcon AP soft contact lens with 8.7 base curve worn in the left eye.

Pair 3: galyfilcon A soft contact lens with 8.3 base curve worn in the right eye and galyfilcon A soft contact lens with 8.7 base curve worn in the left eye.

 Device: galyfilcon AP 8.3 BC
galyfilcon AP 8.3 BC soft contact lens
Device: galyfilcon AP 8.7 BC
galyfilcon AP 8.7 BC soft contact lens
Device: galyfilcon A 8.3 BC
galyfilcon A 8.3 BC soft contact lens
Device: galyfilcon A 8.7 BC
galyfilcon A 8.7 BC soft contact lens
Device: senofilcon A 8.4 BC
senofilcon A 8.4 BC soft contact lens
Device: senofilcon A 8.8 BC
senofilcon A 8.8 BC soft contact lens
seno 8.4/8.8;galy 8.3/8.7;galyP 8.3/8.7

Pair 1: senofilcon A soft contact lens with 8.4 base curve worn in the right eye and senofilcon A soft contact lens with 8.8 base curve worn in the left eye.

Pair 2: galyfilcon A soft contact lens with 8.3 base curve worn in the right eye and galyfilcon A soft contact lens with 8.7 base curve worn in the left eye.

Pair 3: galyfilcon AP soft contact lens with 8.3 base curve worn in the right eye and galyfilcon AP soft contact lens with 8.7 base curve worn in the left eye.

 Device: galyfilcon AP 8.3 BC
galyfilcon AP 8.3 BC soft contact lens
Device: galyfilcon AP 8.7 BC
galyfilcon AP 8.7 BC soft contact lens
Device: galyfilcon A 8.3 BC
galyfilcon A 8.3 BC soft contact lens
Device: galyfilcon A 8.7 BC
galyfilcon A 8.7 BC soft contact lens
Device: senofilcon A 8.4 BC
senofilcon A 8.4 BC soft contact lens
Device: senofilcon A 8.8 BC
senofilcon A 8.8 BC soft contact lens
seno 8.8/8.4;galyP 8.7/8.3;galy 8.7/8.3

Pair 1: senofilcon A soft contact lens with 8.8 base curve worn in the right eye and senofilcon A soft contact lens with 8.4 base curve worn in the left eye.

Pair 2: galyfilcon AP soft contact lens with 8.7 base curve worn in the right eye and galyfilcon AP soft contact lens with 8.3 base curve worn in the left eye.

Pair 3: galyfilcon A soft contact lens with 8.7 base curve worn in the right eye and galyfilcon A soft contact lens with 8.3 base curve worn in the left eye.

 Device: galyfilcon AP 8.3 BC
galyfilcon AP 8.3 BC soft contact lens
Device: galyfilcon AP 8.7 BC
galyfilcon AP 8.7 BC soft contact lens
Device: galyfilcon A 8.3 BC
galyfilcon A 8.3 BC soft contact lens
Device: galyfilcon A 8.7 BC
galyfilcon A 8.7 BC soft contact lens
Device: senofilcon A 8.4 BC
senofilcon A 8.4 BC soft contact lens
Device: senofilcon A 8.8 BC
senofilcon A 8.8 BC soft contact lens
seno 8.8/8.4;galy 8.7/8.3;galyP 8.7/8.3

Pair 1: senofilcon A soft contact lens with 8.8 base curve worn in the right eye and senofilcon A soft contact lens with 8.4 base curve worn in the left eye.

Pair 2: galyfilcon A soft contact lens with 8.7 base curve worn in the right eye and galyfilcon A soft contact lens with 8.3 base curve worn in the left eye.

Pair 3: galyfilcon AP soft contact lens with 8.7 base curve worn in the right eye and galyfilcon AP soft contact lens with 8.3 base curve worn in the left eye.

 Device: galyfilcon AP 8.3 BC
galyfilcon AP 8.3 BC soft contact lens
Device: galyfilcon AP 8.7 BC
galyfilcon AP 8.7 BC soft contact lens
Device: galyfilcon A 8.3 BC
galyfilcon A 8.3 BC soft contact lens
Device: galyfilcon A 8.7 BC
galyfilcon A 8.7 BC soft contact lens
Device: senofilcon A 8.4 BC
senofilcon A 8.4 BC soft contact lens
Device: senofilcon A 8.8 BC
senofilcon A 8.8 BC soft contact lens

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be at least 18 years of age and no more than 55 years of age.
  • Must sign written informed consent.
  • Optimal spherical equivalent distance correction must be between -1.00 and -6.00 diopters.
  • Have spectacle astigmatism ≤ -0.75 diopter cylinder in both eyes.
  • Must have visual acuity best correctable to 20/25+3 or better for each eye.
  • Must appear able and willing to adhere to the instructions set forth in this clinical protocol.
  • Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having: No evidence of lid abnormality or infection; No conjunctival abnormality or infection; No clinical significant slit lamp findings, (i.e., oedema, staining, scarring, vascularization, infiltrates or abnormal opacities); No other active ocular disease.
  • The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of daily wear for a minimum of 1 month prior to the study) and willing to wear the study lenses on a daily wear basis (defined as a minimum of 6 hours of wear per day at least five days of the week) for the duration of the study.

Exclusion Criteria:

  • Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
  • Any previous eye surgery involving the anterior segment.
  • Pre-existing ocular disease that would preclude contact lens fitting.
  • Abnormal lacrimal secretions.
  • Keratoconus or other corneal irregularity.
  • Pregnancy, lactating or planning a pregnancy at the time of enrollment.
  • Participation in any concurrent clinical trial.
  • Subject's habitual contact lens type is toric or multifocal.
  • Require any concurrent ocular medication.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01244529

Locations
United Kingdom
Farnham, Surrey, United Kingdom, GU9 7EN
Birmingham, United Kingdom, B4 7ET
Sponsors and Collaborators
Vistakon
  More Information

No publications provided

Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT01244529     History of Changes
Other Study ID Numbers: CR-201011
Study First Received: November 17, 2010
Results First Received: December 19, 2011
Last Updated: December 19, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2013