Clinical trial NCT02939950: Silicone Hydrogel Soft Contact Lens 7-Day Extended Wear Basis
Official title: A Study to Evaluate the Safety and Effectiveness of a Silicone Hydrogel Soft Contact Lens When Worn on a 7-Day Extended Wear Basis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2016-10-20
Enrollment: 816
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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® soft contact lens when worn for 7-day extended wear by adapted soft contact lens wearers.

Detailed description: Approximately 816 participants (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 participants 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 soft 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. Participants will also be required to complete a paper diary.

Eligibility criteria: Inclusion Criteria:

* Participants must be correctable through spherocylindrical refraction to 42 letters (0.1 logMAR) or better (distance, high contrast) in each eye.
* Participants must be adapted lens wearers and wear a lens in each eye; each lens must be of the same manufacturer and brand.
* Participants must be myopic and require lens correction from -0.50 diopters (D) to 6.00 D in each eye.
* Participants must have clear central corneas and be free of any anterior segment disorders.
* Participants must agree to wear their lenses on an extended wear basis (6 nights/7 days) for the duration of the study.

Exclusion Criteria:

* Participants 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.
* Participants with an active ocular disease or who are using any ocular medication.
* Participants 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.
* Participants using any systemic medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
* Participants who are not correctable to 42 letters (0.1 logMAR) in each eye with soft spherical contact lenses.
* Participants who currently wear monovision, multifocal, or toric contact lenses.

Primary outcomes:
measure: High Contrast Visual Acuity
timeFrame: Month 12
measure: Number of Participants With Adverse Events
timeFrame: Baseline up to Month 12
Secondary outcomes:
Other outcomes:
Locations:
city: Cicero
country: United States
facility: Cicero Family Eye Care
state: New York
Study officials:
affiliation: Bausch Health Americas, Inc.
name: Johnson Varughese
role: STUDY_DIRECTOR
References: