Back to resultsEvaluation of Two Daily Disposable Contact Lenses.
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Experimental- Soflens
Marketed - Soflens
Sponsored by
About this trial
This is an interventional other trial for Myopia focused on measuring contact lens
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 be free of any anterior segment disorders.
- Subjects must be adapted soft contact 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 contact lens correction from -0.50 D to -6.00 D in each eye.
- Subjects must be willing and able to wear the study lenses for at least 8 hours (12 hours or more is recommended) each day throughout the duration of the study.
- Subjects must use a technologic device for an average of 4 hours per day over a week's time and at a minimum of 4 days per week.
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 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 have had any corneal surgery (eg, refractive surgery).
- Subjects who are allergic to any component in the study care products.
- Subjects may not use their habitual rewetting drops while participating in this study.
Sites / Locations
- Bausch & Lomb Incorporated
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental- Soflens
Marketed - Soflens
Arm Description
Bausch & Lomb experimental soflens daily disposable contact lens packaged in an investigational storage solution.
Bausch & Lomb daily disposable marketed soflens contact lens packaged with: 0.5% poloxamine in buffered saline solution.
Outcomes
Primary 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.
Secondary Outcome Measures
Initial Lens Performance Survey
A lens performance survey was given to each participant at the Screening/Dispensing Visit, three minutes following insertion of the study lenses. Lens performance was assessed by eye for the following parameters: burning/stinging upon insertion, comfort upon insertion, ease of handling/insertion, vision upon insertion, and lens cleanness upon insertion. As with symptoms/complaints, responses were on a scale from 0 to 100, with 0 being the most unfavorable score.
Full Information
NCT ID
NCT01300065
First Posted
February 17, 2011
Last Updated
September 11, 2020
Sponsor
Bausch & Lomb Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT01300065
Brief Title
Evaluation of Two Daily Disposable Contact Lenses.
Official Title
A Study to Evaluate the Product Performance of Two Daily Disposable Contact Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
May 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 clinical study is to evaluate the product performance of SofLens daily disposable contact lenses packaged in the investigational Test solution versus SofLens daily disposable contact lenses packaged in Control, solution as it relates to comfort when used by subjects who use technology devices (eg, Personal Digital Assistants [PDAs], computers, electronic game consoles, hand-held electronic devices, electronic book readers, etc) on an average of 4 hours per day over a week's time for a minimum of 4 days each week.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
contact lens
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
441 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental- Soflens
Arm Type
Experimental
Arm Description
Bausch & Lomb experimental soflens daily disposable contact lens packaged in an investigational storage solution.
Arm Title
Marketed - Soflens
Arm Type
Active Comparator
Arm Description
Bausch & Lomb daily disposable marketed soflens contact lens packaged with: 0.5% poloxamine in buffered saline solution.
Intervention Type
Device
Intervention Name(s)
Experimental- Soflens
Intervention Description
A new pair of lenses will be worn each day while the subject is in the study
Intervention Type
Device
Intervention Name(s)
Marketed - Soflens
Intervention Description
A new pair of lenses will be worn each day while the subject is in the study.
Primary 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
2 weeks
Secondary Outcome Measure Information:
Title
Initial Lens Performance Survey
Description
A lens performance survey was given to each participant at the Screening/Dispensing Visit, three minutes following insertion of the study lenses. Lens performance was assessed by eye for the following parameters: burning/stinging upon insertion, comfort upon insertion, ease of handling/insertion, vision upon insertion, and lens cleanness upon insertion. As with symptoms/complaints, responses were on a scale from 0 to 100, with 0 being the most unfavorable score.
Time Frame
At dispensing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 be free of any anterior segment disorders.
Subjects must be adapted soft contact 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 contact lens correction from -0.50 D to -6.00 D in each eye.
Subjects must be willing and able to wear the study lenses for at least 8 hours (12 hours or more is recommended) each day throughout the duration of the study.
Subjects must use a technologic device for an average of 4 hours per day over a week's time and at a minimum of 4 days per week.
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 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 have had any corneal surgery (eg, refractive surgery).
Subjects who are allergic to any component in the study care products.
Subjects may not use their habitual rewetting drops while participating in this study.
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
Evaluation of Two Daily Disposable Contact Lenses.
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