Silicone Hydrogel Soft Contact Lens 7-Day Extended Wear Basis



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - 40
Updated:1/31/2018
Start Date:April 2015
End Date:August 2016

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A Study to Evaluate the Safety and Effectiveness of a Silicone Hydrogel Soft Contact Lens When Worn on a 7-Day Extended Wear Basis

The objective of this study is to evaluate the safety and effectiveness of the Bausch + Lomb
samfilcon A soft (hydrophilic) contact lens, a new silicone hydrogel contact lens, compared
to the Bausch + Lomb PureVision® contact lens when worn for 7-day extended wear by adapted
soft contact lens wearers.

Approximately 816 subjects (1,632 eyes) will be enrolled in this 12-month randomized,
parallel, Investigator/Sponsor masked study at approximately 35 investigative sites in the
US.

At the Screening/Dispensing Visit, approximately one-half of the subjects will be randomized
to receive Bausch + Lomb investigational samfilcon A soft contact lenses (Test) and
approximately one-half of the subjects will be randomized to receive Bausch + Lomb PureVision
contact lenses (Control). Both groups will wear the assigned lenses bilaterally on a 7-day
extended wear basis throughout the 12 month study. The lenses are to be worn overnight for up
to six consecutive nights per week. The lenses are to be removed, cleaned and disinfected on
the seventh night and re-inserted the following morning. The lenses will be replaced with new
lenses at the beginning of each month. Lenses will be provided at the Screening/Dispensing,
3-Month, 6-Month and 9-Month Follow-Up Visits to maintain a monthly replacement schedule.
Subjects will also be required to complete a paper diary.

Inclusion Criteria:

- Subjects must be correctable through spherocylindrical refraction to 42 letters (0.1
Logarithm of the Minimum Angle of Resolution [logMAR]) or better (distance, high
contrast) in each eye.

- Subjects must be adapted lens wearers and wear a lens in each eye; each lens must be
of the same manufacturer and brand.

- Subjects must be myopic and require lens correction from -0.50 diopters (D) to

- 6.00 D in each eye.

- Subjects must have clear central corneas and be free of any anterior segment
disorders.

- Subjects must agree to wear their lenses on an extended wear basis (6 nights/7 days)
for the duration of the study.

Exclusion Criteria:

- Subjects who have worn gas permeable (GP) contact lenses within the last 30 days or
who have worn polymethylmethacrylate (PMMA) lenses within the last three months.

- Subjects with an active ocular disease or who are using any ocular medication.

- Subjects with any systemic disease currently affecting ocular health or which in the
Investigator's opinion may have an effect on ocular health during the course of the
study.

- Subjects using any systemic medications that will, in the Investigator's opinion,
affect ocular physiology or lens performance.

- Subjects who are not correctable to 42 letters (0.1 logMAR) in each eye with soft
spherical contact lenses.

- Subjects who currently wear monovision, multifocal, or toric contact lenses.
We found this trial at
1
site
6197 New York 31
Cicero, New York 13039
?
mi
from
Cicero, NY
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