Clinical Performance Comparison of Several Different Contact Lenses
Status
Completed
Conditions
Myopia
Treatments
Device: lotrafilcon B
Device: balafilcon A
Device: vifilcon A
Device: senofilcon A
Device: methafilcon A
Details and patient eligibility
About
The purpose of the study is to evaluate the possible benefits of second generation silicone hydrogel contact lenses.
Enrollment
71 patients
Sex
All
Ages
18 to 39 years old
Volunteers
No Healthy Volunteers
Inclusion criteria
Subjects must:
- be existing soft contact lens wearers of the study control lenses
- require a distance visual correction in both eyes
- have a contact lens spherical distance requirement between -1.00 diopters (D) and -8.00D in both eyes
- have astigmatism less than or equal to 1.00D in both eyes
- be able to wear lenses available for this study
- be corrected to a visual acuity of 6/9 (20/30) or better in each eye
- have normal eyes with no evidence of abnormality or disease
Exclusion criteria
Subject are excluded for the following reasons:
- monovision corrected
- worn lenses extended wear in the last 3 months.
- require concurrent ocular medication
- grade 3 or 4 abnormalities
- grade 3 corneal staining in more than two regions
- anterior ocular surgery
- any other ocular surgery or injury within 8 weeks prior to study enrollment
- abnormal lachrymal secretions
- pre-existing ocular irritation that would preclude contact lens fitting
- corneal irregularities
- Polymethyl methacrylate (PMMA) or Rigid Gas Permeable (RGP) lens wear in past 12 weeks
- any systemic illness which would preclude contact lens wear
- diabetes
- infectious or immunosuppressive disease
- pregnancy or lactating, or planning pregnancy at time or enrollment
- participating in a concurrent clinical study or within last 60 days
- allergy to the standardized study care solution
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Single Blind
71 participants in 5 patient groups
senofilcon A
Active Comparator group
Description:
contact lens
Treatment:
Device: senofilcon A
lotrafilcon B
Active Comparator group
Description:
contact lens
Treatment:
Device: lotrafilcon B
balafilcon A
Active Comparator group
Description:
contact lens
Treatment:
Device: balafilcon A
methafilcon A
Active Comparator group
Description:
contact lens
Treatment:
Device: methafilcon A
vifilcon A
Active Comparator group
Description:
contact lens
Treatment:
Device: vifilcon A
Trial contacts and locations
11
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Data sourced from clinicaltrials.gov
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