Clinical trial NCT01583868: A Study to Evaluate the Product Feasibility of Two New Silicone Hydrogel Contact Lenses
Official title: A Study to Evaluate the Product Feasibility of Two New Silicone Hydrogel Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2012-04-24
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study is to determine the clinical feasibility and to evaluate the product performance of two RD2135-01 investigational soft contact lenses (Test 1 and Test 2) developed by Bausch + Lomb. The Test lenses will be compared to both Bausch + Lomb PureVision®2 HD (high definition) soft contact lenses and Ciba Vision Air Optix Aqua soft contact lenses when used among currently adapted soft contact lens wearers.


Eligibility criteria: Inclusion Criteria:

* Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
* Be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
* Be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye.
* Be myopic and require lens correction from -0.50 diopters (D) to -6.00 D in each eye.
* Must agree to wear the study lenses on a daily wear basis for the duration of the study.
* Must be willing to use a lens care system on a regular basis.
* If the subject requires a Washout Period, the subject must be willing to discontinue contact lens wear and be willing to wear either spectacles or no lenses during this Washout Period.

Exclusion Criteria:

* Not correctable to 32 letters (0.3 logMAR) in each eye with soft spherical contact lenses.
* Have an active ocular disease, any corneal infiltrative response or are using any ocular medications.
* Have worn gas permeable (GP) contact lenses within last 30 days or PMMA lenses within last 3 months.
* Any scar or neovascularization within the central 4mm of the cornea.
* Any Grade 2 or greater finding during the slit lamp examination, Subjects with corneal infiltrates, of ANY GRADE, are not eligible.
* Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
* Anisometropia (spherical equivalent) of greater than 2.00 D.
* Any systemic disease affecting ocular health.
* Using any systemic or topical medications that will affect ocular physiology or lens performance.
* Aphakic.
* Amblyopic.
* Allergic to any component in the study products.
* Have had any corneal surgery (ie, refractive surgery).
* Currently wear monovision correction, multifocal, or toric contact lenses.
* Ocular astigmatism greater than 1.00 D in either eye.

Primary outcomes:
measure: Visual Acuity
timeFrame: At 1 week follow up
Secondary outcomes:
measure: Symptoms and Complaints
timeFrame: At 1 Week follow up
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch & Lomb Incorporated
state: New York
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Beverly J Barna, CCRA
role: STUDY_DIRECTOR
References: