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

• ClinicalTrials.gov Identifier: NCT01244529
• Recruitment Status: Completed
• First Posted: November 19, 2010
• Results First Posted: January 24, 2012
• Last Update Posted: June 19, 2018
• Sponsor: Johnson & Johnson Vision Care, Inc.
• Information provided by (Responsible Party): Johnson & Johnson Vision Care, Inc.

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Myopia	Device: galy A Plus; Device: seno A; Device: galy A	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 41 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Other
• Actual Study Start Date: September 1, 2010
• Actual Primary Completion Date: November 1, 2010
• Actual Study Completion Date: November 1, 2010

Arms and Interventions

Arm	Intervention/treatment
galy A Plus/ galy A / seno A; Pair 1: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). Pair 2: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). Pair 3: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8).	Device: galy A Plus; galyfilcon A Plus, BC: 8.3 or 8.7; Device: seno A; senofilcon A, BC:8.4 or 8.8; Device: galy A; galyfilcon A , BC: 8.3 or 8.7
galy A Plus / seno A / galy A; Pair 1: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). Pair 2: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8). Pair 3: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).	Device: galy A Plus; galyfilcon A Plus, BC: 8.3 or 8.7; Device: seno A; senofilcon A, BC:8.4 or 8.8; Device: galy A; galyfilcon A , BC: 8.3 or 8.7
galy A / galy A Plus / seno A; Pair 1: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). Pair 2: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). Pair 3: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8).	Device: galy A Plus; galyfilcon A Plus, BC: 8.3 or 8.7; Device: seno A; senofilcon A, BC:8.4 or 8.8; Device: galy A; galyfilcon A , BC: 8.3 or 8.7
galy A / seno A / galy A Plus; Pair 1: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). Pair 2: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8). Pair 3: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).	Device: galy A Plus; galyfilcon A Plus, BC: 8.3 or 8.7; Device: seno A; senofilcon A, BC:8.4 or 8.8; Device: galy A; galyfilcon A , BC: 8.3 or 8.7
seno A / galy A / glay A Plus; Pair 1: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8). Pair 2: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). Pair 3: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).	Device: galy A Plus; galyfilcon A Plus, BC: 8.3 or 8.7; Device: seno A; senofilcon A, BC:8.4 or 8.8; Device: galy A; galyfilcon A , BC: 8.3 or 8.7
seno A / galy A Plus / galy A; Pair 1: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8). Pair 2: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7). Pair 3: galy A -subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).	Device: galy A Plus; galyfilcon A Plus, BC: 8.3 or 8.7; Device: seno A; senofilcon A, BC:8.4 or 8.8; Device: galy A; galyfilcon A , BC: 8.3 or 8.7

Outcome Measures

Primary Outcome Measures :

1. Lens Centration Acceptance [ Time Frame: after 15 minutes of contact lens wear ]
   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.
2. Primary Gaze Lens Movement [ Time Frame: after 15 minutes of contact lens wear ]
   Investigator evaluated as acceptable (minimal or moderate movement) or unacceptable (insufficient or excessive movement). Percent of eyes in each category will be evaluated.
3. Fit Acceptability [ Time Frame: after 15 minutes of contact lens wear ]
   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 :

1. New Lens Power Fit Match to Control Lenses [ Time Frame: after 15 minutes of contact lens wear ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• 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

Locations

United Kingdom

Farnham, Surrey, United Kingdom, GU9 7EN

Birmingham, United Kingdom, B4 7ET

Sponsors and Collaborators

Johnson & Johnson Vision Care, Inc.

More Information

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT01244529
• Other Study ID Numbers: CR-201011
• First Posted: November 19, 2010
• Results First Posted: January 24, 2012
• Last Update Posted: June 19, 2018
• Last Verified: August 2017

Additional relevant MeSH terms:

Myopia; Refractive Errors; Eye Diseases