Status:
COMPLETED
A Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens
Lead Sponsor:
Bausch & Lomb Incorporated
Conditions:
Myopia
Eligibility:
All Genders
18-35 years
Phase:
NA
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
- 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
- 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.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT01873846
Start Date
April 1 2013
End Date
July 1 2013
Last Update
July 24 2019
Active Locations (1)
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1
Bausch & Lomb Incorporated
Madison, New Jersey, United States, 07940