Clinical trial NCT01094730: Pilot Evaluation of a New Galyfilcon A Contact Lens Compared to a Marketed Galyfilcon A Contact Lens
Official title: A Multi-site Dispensing Evaluation Comparing a New Galyfilcon A Prototype Lens With a Marketed Galyfilcon A Contact Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2010-03-29
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare lens surface characteristics and comfort between an experimental contact lens and a marketed contact lens.


Eligibility criteria: Inclusion Criteria:

* The subject must be at least 18 years of age and no more than 39 years of age.
* The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of daily wear (DW) 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.
* The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 9.00D.
* Any cylinder power must be ≤ -0.75D.
* The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
* The subject must read and sign the Statement of Informed Consent.
* The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion Criteria:

* Ocular or systemic allergies or disease which might interfere with contact lens wear.
* Systemic disease or use of medication which might interfere with contact lens wear.
* Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
* Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
* Any ocular infection.
* Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
* Pregnancy or lactation.
* Diabetes.
* Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
* Habitual contact lens type is toric, multifocal, or is worn as extended wear.

Primary outcomes:
measure: Lens Front Surface Deposits at Day 7
timeFrame: Evaluated at Day 7
measure: Lens Front Surface Deposits at Day 14
timeFrame: Evaluated at Day 14
Secondary outcomes:
measure: Subject Reported Overall Lens Comfort at Day 7
timeFrame: Evaluated at Day 7
measure: Subject Reported Overall Lens Comfort at Day 14
timeFrame: Evaluated at Day 14
Other outcomes:
Locations:
city: Cupertino
country: United States
state: California
city: Huntington Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Pismo Beach
country: United States
state: California
city: Jacksonville
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: East Lansing
country: United States
state: Michigan
city: Columbus
country: United States
state: Ohio
city: Amarillo
country: United States
state: Texas
Study officials:
References: