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: January 15, 2014
Last verified: January 2014
  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 A Plus (test)
Device: galyfilcon A (control)
Device: senofilcon A (control)

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

Resource links provided by NLM:


Further study details as provided by Vistakon:

Primary Outcome Measures:
  • Lens Centration Acceptance [ Time Frame: after 15 minutes of contact lens wear ] [ Designated as safety issue: No ]
    Investigator evaluated as acceptable (centered/slightly decentered) or unacceptable (substantially decentered). Number of eyes in each category will be reported by lens. This is an aggregate reporting of the lenses, combining the different base curves into a category by lens type. This is done per protocol, due to this primary outcome not being stratified by base curve.

  • Primary Gaze Lens Movement [ Time Frame: after 15 minutes of contact lens wear ] [ Designated as safety issue: No ]
    Investigator evaluated as acceptable (minimal or moderate movement) or unacceptable (insufficient or excessive movement). 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 lens fit using a six point scale: 5-optimal...3-borderline acceptable...2-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
galy A Plus/ galy A / seno A

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

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

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

Device: galyfilcon A Plus (test)
galyfilcon A Plus 8.3 or 8.7 BC soft contact lens
Device: galyfilcon A (control)
galyfilcon A 8.3 or 8.7 BC soft contact lens
Device: senofilcon A (control)
senofilcon A 8.4 or 8.8 BC soft contact lens
galy A Plus / seno A / galy A

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

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

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

Device: galyfilcon A Plus (test)
galyfilcon A Plus 8.3 or 8.7 BC soft contact lens
Device: galyfilcon A (control)
galyfilcon A 8.3 or 8.7 BC soft contact lens
Device: senofilcon A (control)
senofilcon A 8.4 or 8.8 BC soft contact lens
galy A Plus / galy A / seno A

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

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

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

Device: galyfilcon A Plus (test)
galyfilcon A Plus 8.3 or 8.7 BC soft contact lens
Device: galyfilcon A (control)
galyfilcon A 8.3 or 8.7 BC soft contact lens
Device: senofilcon A (control)
senofilcon A 8.4 or 8.8 BC soft contact lens
galy A Plus / seno A / galy A

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

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

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

Device: galyfilcon A Plus (test)
galyfilcon A Plus 8.3 or 8.7 BC soft contact lens
Device: galyfilcon A (control)
galyfilcon A 8.3 or 8.7 BC soft contact lens
Device: senofilcon A (control)
senofilcon A 8.4 or 8.8 BC soft contact lens
galy A / galy A Plus / seno A

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

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

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

Device: galyfilcon A Plus (test)
galyfilcon A Plus 8.3 or 8.7 BC soft contact lens
Device: galyfilcon A (control)
galyfilcon A 8.3 or 8.7 BC soft contact lens
Device: senofilcon A (control)
senofilcon A 8.4 or 8.8 BC soft contact lens
galy A / seno A / galy A Plus

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

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

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

Device: galyfilcon A Plus (test)
galyfilcon A Plus 8.3 or 8.7 BC soft contact lens
Device: galyfilcon A (control)
galyfilcon A 8.3 or 8.7 BC soft contact lens
Device: senofilcon A (control)
senofilcon A 8.4 or 8.8 BC soft contact lens
galy A / galy A Plus / seno A

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

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

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

Device: galyfilcon A Plus (test)
galyfilcon A Plus 8.3 or 8.7 BC soft contact lens
Device: galyfilcon A (control)
galyfilcon A 8.3 or 8.7 BC soft contact lens
Device: senofilcon A (control)
senofilcon A 8.4 or 8.8 BC soft contact lens
galy A / seno A / galy A P

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

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

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

Device: galyfilcon A Plus (test)
galyfilcon A Plus 8.3 or 8.7 BC soft contact lens
Device: galyfilcon A (control)
galyfilcon A 8.3 or 8.7 BC soft contact lens
Device: senofilcon A (control)
senofilcon A 8.4 or 8.8 BC soft contact lens
seno A / galy A Plus / galy A

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

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

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

Device: galyfilcon A Plus (test)
galyfilcon A Plus 8.3 or 8.7 BC soft contact lens
Device: galyfilcon A (control)
galyfilcon A 8.3 or 8.7 BC soft contact lens
Device: senofilcon A (control)
senofilcon A 8.4 or 8.8 BC soft contact lens
seno A / galy A / galy A Plus

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

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

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

Device: galyfilcon A Plus (test)
galyfilcon A Plus 8.3 or 8.7 BC soft contact lens
Device: galyfilcon A (control)
galyfilcon A 8.3 or 8.7 BC soft contact lens
Device: senofilcon A (control)
senofilcon A 8.4 or 8.8 BC soft contact lens
seno A / galy A Plus A / galy A

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

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

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

Device: galyfilcon A Plus (test)
galyfilcon A Plus 8.3 or 8.7 BC soft contact lens
Device: galyfilcon A (control)
galyfilcon A 8.3 or 8.7 BC soft contact lens
Device: senofilcon A (control)
senofilcon A 8.4 or 8.8 BC soft contact lens
seno A / galy / galy A Plus

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

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

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

Device: galyfilcon A Plus (test)
galyfilcon A Plus 8.3 or 8.7 BC soft contact lens
Device: galyfilcon A (control)
galyfilcon A 8.3 or 8.7 BC soft contact lens
Device: senofilcon A (control)
senofilcon A 8.4 or 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: January 15, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

ClinicalTrials.gov processed this record on September 16, 2014