Back to resultsA Study to Evaluate the Product Feasibility of a New Silicone Hydrogel Contact Lens
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bausch & Lomb Test lens
Ciba Vision soft contact lens
Sponsored by
About this trial
This is an interventional screening trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings (greater than grade 1 and/or presence of infiltrates).
- 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 to -6.00 diopters (D) in each eye.
Exclusion Criteria:
- 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 Grade 2 or greater finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
- Any scar or neovascularization within the central 4mm of the cornea.
- Have had any corneal surgery.
- Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
- Any systemic disease affecting ocular health.
- Using any systemic or topical medications that will affect ocular physiology or lens performance.
- Currently wear monovision, multifocal, or toric contact lenses.
- Allergic to any component in the study care products.
Sites / Locations
- Bausch & Lomb Incorporated
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Bausch & Lomb Test Lens
Ciba Vision soft contact lens
Arm Description
Bausch + Lomb investigational soft contact lens
Ciba Vision Air Optix Aqua soft contact lens
Outcomes
Primary Outcome Measures
Visual Acuity
The mean difference in high contrast logMAR, over all lens visual acuities (VAs) between lens groups.
Secondary Outcome Measures
Overall Comfort
The mean difference in comfort-related symptoms/complaints scores between lens groups. Rated on a scale of 0-100 with 100 being the most favorable score.
Full Information
NCT ID
NCT01412983
First Posted
August 8, 2011
Last Updated
March 27, 2014
Sponsor
Bausch & Lomb Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT01412983
Brief Title
A Study to Evaluate the Product Feasibility of a New Silicone Hydrogel Contact Lens
Official Title
A Study to Evaluate the Product Feasibility of a New Silicone Hydrogel Contact Lens
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
October 2011 (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 determine the clinical feasibility and to evaluate the product performance of investigational contact lenses developed by Bausch + Lomb.
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
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bausch & Lomb Test Lens
Arm Type
Experimental
Arm Description
Bausch + Lomb investigational soft contact lens
Arm Title
Ciba Vision soft contact lens
Arm Type
Active Comparator
Arm Description
Ciba Vision Air Optix Aqua soft contact lens
Intervention Type
Device
Intervention Name(s)
Bausch & Lomb Test lens
Intervention Description
Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses.
Intervention Type
Device
Intervention Name(s)
Ciba Vision soft contact lens
Intervention Description
Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses.
Primary Outcome Measure Information:
Title
Visual Acuity
Description
The mean difference in high contrast logMAR, over all lens visual acuities (VAs) between lens groups.
Time Frame
One week
Secondary Outcome Measure Information:
Title
Overall Comfort
Description
The mean difference in comfort-related symptoms/complaints scores between lens groups. Rated on a scale of 0-100 with 100 being the most favorable score.
Time Frame
One week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings (greater than grade 1 and/or presence of infiltrates).
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 to -6.00 diopters (D) in each eye.
Exclusion Criteria:
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 Grade 2 or greater finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
Any scar or neovascularization within the central 4mm of the cornea.
Have had any corneal surgery.
Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
Any systemic disease affecting ocular health.
Using any systemic or topical medications that will affect ocular physiology or lens performance.
Currently wear monovision, multifocal, or toric contact lenses.
Allergic to any component in the study care products.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beverly J Barna, CCRA
Organizational Affiliation
Bausch & Lomb Incorporated
Official's Role
Study Director
Facility Information:
Facility Name
Bausch & Lomb Incorporated
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Product Feasibility of a New Silicone Hydrogel Contact Lens
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