Clinical trial NCT01873846: A Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens
Official title: A Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2013-06-10
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The objective of this study is to evaluate the product performance of a new silicone hydrogel soft contact lens when worn by current soft contact lens wearers on a daily wear basis.


Eligibility criteria: Inclusion Criteria:

* Subjects must be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye
* Subjects must have clear central corneas and be free of any anterior segment disorders.
* Subjects must be adapted lens wearers and wear a lens in each eye and each lens must be of the same manufacture and brand.
* Subjects must be myopic and require lens correction from -0.25 D to -6.00 D in each eye.
* Subject must wear their current lenses for a minimum of 12 hours per day at least four days per week.
* Subjects must spend at least 3 hours each workday using a computer or electronic device (ie, smartphones, tablets, eReaders).
* Subjects must habitually wear soft contact lens.
* Subject must have no active ocular disease or allergic conjunctivitis.
* Subject must not be using any topical ocular medications.
* Subjects must be bothered (occasionally or frequently) by blurriness or fluctuations in vision with their current contact lenses.
* Subjects must habitually use a lens care product for cleaning, disinfection, and storage.

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 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 or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
* Subjects with an active ocular disease or who are using any ocular medication.
* Subjects who are not correctable to 32 letters (0.3 logMAR) in each eye with soft spherical contact lenses.
* Subjects who are presbyopic or currently wear monovision, multifocal, or toric contact lenses.
* Subjects with an ocular astigmatism of 1.00 D or greater in either eye.
* Subjects with anisometropia (spherical equivalent) of 2.00 D or greater in either eye.
* Subjects with any Grade 2 or greater finding during the slit lamp examination.
* Subjects with corneal infiltrates, of ANY GRADE, are not eligible.
* Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
* Subjects with any scar or neovascularization within the central 4 mm of the cornea.
* Subjects who are aphakic.
* Subjects who are amblyopic.
* Subjects who have had any corneal surgery (eg, refractive surgery).
* Subjects who are allergic to any component in the study care products.
* Subjects who are bothered by blurriness or fluctuations in vision due to itchy eyes, something on or under the lens, allergies, or cigarette smoke.

Primary outcomes:
measure: Preference Question: How Would You Say These Contact Lenses Compare Overall With the Contact Lenses You Usually Use?
timeFrame: 7 days
measure: Preference Question: These Contact Lenses Deliver Exceptional Clarity and Comfort All Day Long.
timeFrame: 7 days
measure: Preference Question: These Contact Lenses Help Maintain Healthy, White Eyes.
timeFrame: 7 days
Secondary outcomes:
measure: Lens Performance Assessment
timeFrame: 2 weeks
measure: Any Graded Slit Lamp Finding > 2
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Madison
country: United States
facility: Bausch & Lomb Incorporated
state: New Jersey
Study officials:
affiliation: Valeant Pharmaceuticals
name: Johnson Varughese
role: STUDY_DIRECTOR
References: