A Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Silicone Hydrogel Contact Lens

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Madison, New Jersey, United States, 07940
      • Bausch & Lomb Incorporated

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Silicone Hydrogel Contact Lens; Contact lenses to be worn in each eye on a daily wear basis for 2 weeks. Participants will be provided with Bausch + Lomb Biotrue® multi-purpose solution and contact lens cases for daily rinsing, cleaning, disinfecting, and storing their lenses.	Device: Silicone Hydrogel Contact Lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preference Question: How Would You Say These Contact Lenses Compare Overall With the Contact Lenses You Usually Use?	Participants will respond to a survey regarding their experience wearing the Test Lens after 7 days of wear. Participants were asked to answer the following question: "How would you say these contact lenses compare overall with the contact lenses you usually use?" Prefer study lenses Prefer usual lenses About the same as usual lenses	7 days
Preference Question: These Contact Lenses Deliver Exceptional Clarity and Comfort All Day Long.	Participants will respond to a survey regarding their experience wearing the Test Lens after 7 days of wear. Participants were asked to assess the following statement with respect to their usual contact lenses: "These contact lenses deliver exceptional clarity and comfort all day long." Prefer study lenses Prefer usual lenses About the same as usual lenses	7 days
Preference Question: These Contact Lenses Help Maintain Healthy, White Eyes.	Participants will respond to a survey regarding their experience wearing the Test Lens after 7 days of wear. Participants were asked to assess the following statement with respect to their usual contact lenses: "These contact lenses help maintain healthy, white eyes." Prefer study lenses Prefer usual lenses About the same as usual lenses	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lens Performance Assessment	High Contrast Distance logMAR Lens VA Change From Baseline to Week 2.	2 weeks
Any Graded Slit Lamp Finding > 2	Slit lamp findings for each eye, including epithelial edema, epithelial microcysts, corneal staining, limbal and bulbar injections, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates, were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). Corneal staining grades were computed as the maximum grade over grades taken within each of five different eye locations (central, inferior, nasal, superior, and temporal). Eyes with multiple visits are counted once for the highest grade.	2 weeks

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated
• Investigators: Study Director: Johnson Varughese, Valeant Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: May 28, 2013
• First Submitted That Met QC Criteria: June 7, 2013
• First Posted (Estimate): June 10, 2013

Study Record Updates

• Last Update Posted (Actual): July 24, 2019
• Last Update Submitted That Met QC Criteria: July 23, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: 817