Back to resultsA Study to Evaluate the Performance of Two Designs of Soft Toric Lenses
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Investigational Toric Lens
PureVision Toric Lens
Sponsored by
About this trial
This is an interventional other trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- Subjects must have clear central corneas and be free of any anterior segment disorders.
- Subjects must be adapted lens wearers, 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
- Subjects must be habitual wearers of toric soft contact lenses.
Exclusion Criteria:
- 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 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 who are allergic to any component in the study care products.
Sites / Locations
- Bausch & Lomb
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Investigational Toric Lens
PureVision Toric Lens
Arm Description
Bausch + Lomb investigational toric contact lenses
Currently marketed Bausch + Lomb PureVision toric contact lenses
Outcomes
Primary Outcome Measures
Percentage of Eyes With Absolute Lens Rotation ≤ 10 Degrees.
Visual Acuity
Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).
Secondary Outcome Measures
Symptoms and Complaints
Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints. Symptoms/complaints were recorded at each post-dispensing visit based on the subject's experience with the study lens worn prior to the visit. The symptoms/complaints parameters were: Burning/stinging upon insertion; Comfort upon insertion, Overall comfort, and Comfort at the end of the day; Ease of handling/insertion, and Ease of handling/removal; Dryness; Itchiness; Redness; Vision; Lens cleanliness; and Overall impression.
Percentage of Eyes With > Grade 2 Slit Lamp Findings
Graded 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). The outcome measure is any finding > grade 2, across abnormalities.
Full Information
NCT ID
NCT01309867
First Posted
March 4, 2011
Last Updated
October 5, 2020
Sponsor
Bausch & Lomb Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT01309867
Brief Title
A Study to Evaluate the Performance of Two Designs of Soft Toric Lenses
Official Title
A Study to Evaluate the Performance of Two Designs of Soft Toric Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
April 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 the study is to evaluate the product performance of the Bausch + Lomb toric investigational contact lenses compared to the currently marketed PureVision toric contact lenses.
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
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
302 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Investigational Toric Lens
Arm Type
Experimental
Arm Description
Bausch + Lomb investigational toric contact lenses
Arm Title
PureVision Toric Lens
Arm Type
Active Comparator
Arm Description
Currently marketed Bausch + Lomb PureVision toric contact lenses
Intervention Type
Device
Intervention Name(s)
Investigational Toric Lens
Intervention Description
Bausch & Lomb investigational toric contact lens worn on a daily wear basis for 2 weeks.
Intervention Type
Device
Intervention Name(s)
PureVision Toric Lens
Intervention Description
Currently marked Bausch & Lomb PureVision Toric Lens worn on a daily wear basis for 2 weeks.
Primary Outcome Measure Information:
Title
Percentage of Eyes With Absolute Lens Rotation ≤ 10 Degrees.
Time Frame
2 weeks
Title
Visual Acuity
Description
Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Symptoms and Complaints
Description
Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints. Symptoms/complaints were recorded at each post-dispensing visit based on the subject's experience with the study lens worn prior to the visit. The symptoms/complaints parameters were: Burning/stinging upon insertion; Comfort upon insertion, Overall comfort, and Comfort at the end of the day; Ease of handling/insertion, and Ease of handling/removal; Dryness; Itchiness; Redness; Vision; Lens cleanliness; and Overall impression.
Time Frame
2 weeks
Title
Percentage of Eyes With > Grade 2 Slit Lamp Findings
Description
Graded 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). The outcome measure is any finding > grade 2, across abnormalities.
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects must have clear central corneas and be free of any anterior segment disorders.
Subjects must be adapted lens wearers, 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
Subjects must be habitual wearers of toric soft contact lenses.
Exclusion Criteria:
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 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 who are allergic to any component in the study care products.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beverly Barna
Organizational Affiliation
Bausch & Lomb Incorporated
Official's Role
Study Director
Facility Information:
Facility Name
Bausch & Lomb
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 Performance of Two Designs of Soft Toric Lenses
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