Back to resultsA Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Silicone Hydrogel Contact Lens
Sponsored by
About this trial
This is an interventional screening trial for Myopia
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.
Sites / Locations
- Bausch & Lomb Incorporated
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Silicone Hydrogel Contact Lens
Arm Description
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.
Outcomes
Primary Outcome Measures
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
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
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
Secondary Outcome Measures
Lens Performance Assessment
High Contrast Distance logMAR Lens VA Change From Baseline to Week 2.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01873846
Brief Title
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
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Silicone Hydrogel Contact Lens
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Silicone Hydrogel Contact Lens
Primary Outcome Measure Information:
Title
Preference Question: How Would You Say These Contact Lenses Compare Overall With the Contact Lenses You Usually Use?
Description
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
Time Frame
7 days
Title
Preference Question: These Contact Lenses Deliver Exceptional Clarity and Comfort All Day Long.
Description
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
Time Frame
7 days
Title
Preference Question: These Contact Lenses Help Maintain Healthy, White Eyes.
Description
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
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Lens Performance Assessment
Description
High Contrast Distance logMAR Lens VA Change From Baseline to Week 2.
Time Frame
2 weeks
Title
Any Graded Slit Lamp Finding > 2
Description
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.
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson Varughese
Organizational Affiliation
Valeant Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Bausch & Lomb Incorporated
City
Madison
State/Province
New Jersey
ZIP/Postal Code
07940
Country
United States
12. IPD Sharing Statement
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A Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens
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