Back to resultsEvaluation of the Feasibility a New Silicone Hydrogel Contact Lens
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Investigational lens
Air Optix Aqua lens
Sponsored by
About this trial
This is an interventional other trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
- Be myopic and require lens correction in each eye.
- Be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
Exclusion Criteria:
- Any systemic disease affecting ocular health.
- Using any systemic or topical medications that will affect ocular physiology or lens performance.
- An active ocular disease, any corneal infiltrative response or are using any ocular medications.
- Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
- 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
Investigational lens
Air Optix Aqua lens
Arm Description
Bausch & Lomb investigational silicone hydrogel lens
Ciba Vision Air Optix Aqua contact lens
Outcomes
Primary Outcome Measures
Visual Acuity
Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).
Secondary Outcome Measures
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.
Symptoms and Complaints
At 1-Week Follow-up, subjects were asked to rate 16 common symptoms/complaints on a scale of 0 to 100, with 100 being the most favorable score.
Full Information
NCT ID
NCT01309906
First Posted
March 4, 2011
Last Updated
September 29, 2020
Sponsor
Bausch & Lomb Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT01309906
Brief Title
Evaluation of the Feasibility 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
September 2020
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
February 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 an investigational contact lens.
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
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Investigational lens
Arm Type
Experimental
Arm Description
Bausch & Lomb investigational silicone hydrogel lens
Arm Title
Air Optix Aqua lens
Arm Type
Active Comparator
Arm Description
Ciba Vision Air Optix Aqua contact lens
Intervention Type
Device
Intervention Name(s)
Investigational lens
Intervention Description
Bausch & Lomb investigational silicone hydrogel contact lens worn on a daily wear basis for 1 week.
Intervention Type
Device
Intervention Name(s)
Air Optix Aqua lens
Intervention Description
Ciba Visions Air Optix Aqua contact lens, worn on a daily wear basis for 1 week.
Primary Outcome Measure Information:
Title
Visual Acuity
Description
Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).
Time Frame
At 1 week follow up
Secondary Outcome Measure Information:
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
At 1 week follow up
Title
Symptoms and Complaints
Description
At 1-Week Follow-up, subjects were asked to rate 16 common symptoms/complaints on a scale of 0 to 100, with 100 being the most favorable score.
Time Frame
At 1 week follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
Be myopic and require lens correction in each eye.
Be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
Exclusion Criteria:
Any systemic disease affecting ocular health.
Using any systemic or topical medications that will affect ocular physiology or lens performance.
An active ocular disease, any corneal infiltrative response or are using any ocular medications.
Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
Allergic to any component in the study care products.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tara Vaz, OD
Organizational Affiliation
Bausch & Lomb Incorporated
Official's Role
Principal Investigator
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
Evaluation of the Feasibility a New Silicone Hydrogel Contact Lens
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