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

Myopia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01244529
• Other study ID #: CR-201011
• Status: Completed
• Phase: N/A
• Start date: September 1, 2010
• Est. completion date: November 1, 2010

Study information

• Verified date: August 2017
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: November 1, 2010
• Est. primary completion date: November 1, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• galy A Plus
galyfilcon A Plus, BC: 8.3 or 8.7
• seno A
senofilcon A, BC:8.4 or 8.8
• galy A
galyfilcon A , BC: 8.3 or 8.7

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lens Centration Acceptance	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.	after 15 minutes of contact lens wear
Primary	Primary Gaze Lens Movement	Investigator evaluated as acceptable (minimal or moderate movement) or unacceptable (insufficient or excessive movement). Percent of eyes in each category will be evaluated.	after 15 minutes of contact lens wear
Primary	Fit Acceptability	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.	after 15 minutes of contact lens wear
Secondary	New Lens Power Fit Match to Control Lenses	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.	after 15 minutes of contact lens wear