Back to resultsEvaluation Of One Silicone Hydrogel Contact Lens and Two Hydrogel Lenses in Daily Wear
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
fanfilcon A test lens
ocufilcon D control lens
etafilcon A control lens
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- Be a currently adapted soft contact lens wearer (>1 month of lens wear).
- Be at least 18 years of age.
- Refractive astigmatism <1.00D in both eyes.
- Have clear corneas and be free of any anterior segment disorders.
- Be correctable through spherocylindrical refraction to 20/25 or better in each eye.
- Contact lens sphere requirement between -1.00D and -6.00D (inclusive).
- Require visual correction in both eyes (monovision allowed, no monofit).
Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
- No amblyopia
- No strabismus
- No evidence of lid abnormality or infection
- No conjunctival abnormality or infection that would contraindicate contact lens wear
- No clinically significant slit lamp findings (i.e. corneal staining, stromal edema, staining, scarring, vascularization, infiltrates or abnormal opacities)
- No other active ocular disease.
- Own a mobile phone and be able to respond to SMS survey during the period 8am-8pm.
- Willing to comply with the wear and study visit schedule.
Exclusion Criteria:
- Using CooperVision Avaira Vitality, J&J Acuvue 2 or CooperVision Biomedics 55.
- Require toric or multifocal contact lenses.
- Previously shown a sensitivity to any of the study solution components.
- Any systemic or ocular disease or allergies affecting ocular health.
- Using systemic or topical medications that will in the investigator's opinion affect ocular physiology or lens performance.
- Clinically significant (>Grade 3) corneal staining, corneal stromal edema, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
- Any corneal infiltrates or any corneal scarring or neovascularization within the central 5mm of the cornea.
- Keratoconus or other corneal irregularity.
- Aphakia or amblyopia.
- Have undergone corneal refractive surgery or any anterior segment surgery.
- Abnormal lacrimal secretions.
- Has diabetes.
- Known/reported infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
- History of chronic eye disease (e.g. glaucoma).
- Pregnant or lactating or planning a pregnancy at the time of enrolment.
- Participation in any concurrent clinical trial or in last 30 days.
Sites / Locations
- Golden Optometric Group
- Omega Vision Center PA (DBA Sabal Eye Care)
- Golden Vision
- Sacco Eye Group
- Frazier Vision, Inc
- Office of William J. Bogus, O.D.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
ocufilcon D control lens, then fanfilcon A test lens
etafilcon A controls, then fanfilcon A test lens
Arm Description
Participants will wear the ocufilcon D control lens for 4 weeks, then crossover to fanfilcon A test lens for 4 weeks of daily wear.
Participants will wear the etafilcon D control lens for 2 weeks, then crossover to fanfilcon A test lens for 2 weeks of daily wear.
Outcomes
Primary Outcome Measures
Subjective Overall Comfort Rating
Subjective overall comfort rating was assessed on a 0-10 subjective scale, 0=extremely uncomfortable, 10=can't feel lenses
Subjective Overall Comfort Rating
Subjective overall comfort rating was assessed on a 0-10 subjective scale, 0=extremely uncomfortable, 10=can't feel lenses
Secondary Outcome Measures
Average Wearing Time
Average wearing time - measured by time of day using 24-hour clock, to the nearest 10 minutes
Average Wearing Time
Average wearing time - measured by time of day using 24-hour clock, to the nearest 10 minutes
Average Comfortable Wearing Time
Average comfortable wearing time was assessed by time of day when first aware of lenses using 24-hour clock, to the nearest 10 minutes.
Average Comfortable Wearing Time
Average comfortable wearing time was assessed by time of day when first aware of lenses using 24-hour clock, to the nearest 10 minutes.
Lens Centration
Lens centration will be recorded in the scale of 0 to 2 (0=centered - optimal, 1 = decentered slightly, 2 = substantially decentered (>0.5mm)).
Lens Centration
Lens centration will be recorded in the scale of 0 to 2 (0=centered - optimal, 1 = decentered slightly, 2 = substantially decentered (>0.5mm)).
Lens Centration
Lens centration will be recorded in the scale of 0 to 2 (0=centered - optimal, 1 = decentered slightly, 2 = substantially decentered (>0.5mm)).
Corneal Coverage
Corneal coverage (yes=full corneal coverage all times / no=incomplete corneal coverage)
Corneal Coverage
Corneal coverage (yes=full corneal coverage all times / no=incomplete corneal coverage)
Corneal Coverage
Corneal coverage (yes=full corneal coverage all times / no=incomplete corneal coverage)
Post-Blink Movement
Post-blink movement measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)
Post-Blink Movement
Post-blink movement measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)
Post-Blink Movement
Post-blink movement measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)
Lens Tightness - Push-up Test
Lens tightness - push-up test 0-100% continuous scale (100%=movement, 50%=optimum, 0%=Falls from cornea without lid support)
Lens Tightness - Push-up Test
Lens tightness - push-up test 0-100% continuous scale (100%=movement, 50%=optimum, 0%=Falls from cornea without lid support)
Lens Tightness - Push-up Test
Lens tightness - push-up test 0-100% continuous scale (100%=movement, 50%=optimum, 0%=Falls from cornea without lid support)
Overall Lens Fit Acceptance
Overall lens fit acceptance - Graded on a scale of 0-4 (0=should not be worn, 1=borderline but not acceptable, 2=minimal acceptable, 3=not perfect but OK to dispense, 4=perfect)
Overall Lens Fit Acceptance
Overall lens fit acceptance - Graded on a scale of 0-4 (0=should not be worn, 1=borderline but not acceptable, 2=minimal acceptable, 3=not perfect but OK to dispense, 4=perfect)
Overall Lens Fit Acceptance
Overall lens fit acceptance - Graded on a scale of 0-4 (0=should not be worn, 1=borderline but not acceptable, 2=minimal acceptable, 3=not perfect but OK to dispense, 4=perfect)
Rating of Lens Surface Wettability
Lens surface wettability rated on the appearance on the lens surface (0-4 scale, 0=Very poor: immediately displaying non-wetting areas on lens surface, 4=Excellent: appearance of a healthy cornea with very long drying time).
Rating of Lens Surface Wettability
Lens surface wettability rated on the appearance on the lens surface (0-4 scale, 0=Very poor: immediately displaying non-wetting areas on lens surface, 4=Excellent: appearance of a healthy cornea with very long drying time).
Rating of Lens Surface Wettability
Lens surface wettability rated on the appearance on the lens surface (0-4 scale, 0=Very poor: immediately displaying non-wetting areas on lens surface, 4=Excellent: appearance of a healthy cornea with very long drying time).
Presence of Film Deposits
Presence of film deposits on front surface of the lens graded 0-4 (0=No film, 1=Slight film visible only under magnification, 2=Moderate film only under magnification, 3=Moderate film visible to the naked eye, 4=heavy film visible to the naked eye).
Presence of Film Deposits
Presence of film deposits on front surface of the lens graded 0-4 (0=No film, 1=Slight film visible only under magnification, 2=Moderate film only under magnification, 3=Moderate film visible to the naked eye, 4=heavy film visible to the naked eye).
Number of White Spot Deposits
Number of white spot deposits assessed using slit lamp with white light, low medium magnification
Number of White Spot Deposits
Number of white spot deposits assessed using slit lamp with white light, low medium magnification
Primary Gaze Lag
Primary gaze lag measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)
Primary Gaze Lag
Primary gaze lag measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)
Primary Gaze Lag
Primary gaze lag measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)
Comfort Throughout the Day
Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses
Comfort Throughout the Day
Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses
Comfort Throughout the Day
Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses
Comfort Throughout the Day
Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses
Comfort Throughout the Day
Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses
Comfort Throughout the Day
Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses
Comfort Throughout the Day
Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses
Comfort Throughout the Day
Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses
Comfort Throughout the Day
Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses
Comfort Throughout the Day
Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses
Comfort Throughout the Day
Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses
Comfort Throughout the Day
Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses
Comfort Throughout the Day
Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses
Comfort Throughout the Day
Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses
Comfort Throughout the Day
Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses
Comfort Throughout the Day
Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04050618
Brief Title
Evaluation Of One Silicone Hydrogel Contact Lens and Two Hydrogel Lenses in Daily Wear
Official Title
Multi-Center Cross-Over Evaluation Of Avaira Vitality Silicone Hydrogel Contact Lens and Two Hydrogel Lenses in Daily Wear
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
June 9, 2019 (Actual)
Primary Completion Date
September 24, 2019 (Actual)
Study Completion Date
November 8, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coopervision, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the comparative clinical performance of the fanfilcon A silicone hydrogel lens used in daily wear and to compare this with competitive hydrogel lens products.
Detailed Description
This 8-week, subject-masked, bilateral, two-part, cross-over evaluation will compare the clinical performance of fanfilcon A silicone hydrogel contact lens and competitive hydrogel contact lenses when worn daily. Lenses will be replaced either on a 2-weekly or 4-weekly basis, depending on control lens group.
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
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Masking Description
Subjects will be masked to lens type. Investigators will be unmasked.
Allocation
Non-Randomized
Enrollment
114 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ocufilcon D control lens, then fanfilcon A test lens
Arm Type
Experimental
Arm Description
Participants will wear the ocufilcon D control lens for 4 weeks, then crossover to fanfilcon A test lens for 4 weeks of daily wear.
Arm Title
etafilcon A controls, then fanfilcon A test lens
Arm Type
Experimental
Arm Description
Participants will wear the etafilcon D control lens for 2 weeks, then crossover to fanfilcon A test lens for 2 weeks of daily wear.
Intervention Type
Device
Intervention Name(s)
fanfilcon A test lens
Other Intervention Name(s)
test lens, Avaira Vitality
Intervention Description
Silicone hydrogel contact lens
Intervention Type
Device
Intervention Name(s)
ocufilcon D control lens
Other Intervention Name(s)
Biomedics 55 Premier, ocufilcon D (4-weekly) control lens
Intervention Description
hydrogel contact lens
Intervention Type
Device
Intervention Name(s)
etafilcon A control lens
Other Intervention Name(s)
etafilcon A (2-weekly) control lens, Acuvue 2
Intervention Description
hydrogel contact lens
Primary Outcome Measure Information:
Title
Subjective Overall Comfort Rating
Description
Subjective overall comfort rating was assessed on a 0-10 subjective scale, 0=extremely uncomfortable, 10=can't feel lenses
Time Frame
Two weeks
Title
Subjective Overall Comfort Rating
Description
Subjective overall comfort rating was assessed on a 0-10 subjective scale, 0=extremely uncomfortable, 10=can't feel lenses
Time Frame
Four weeks
Secondary Outcome Measure Information:
Title
Average Wearing Time
Description
Average wearing time - measured by time of day using 24-hour clock, to the nearest 10 minutes
Time Frame
Two weeks
Title
Average Wearing Time
Description
Average wearing time - measured by time of day using 24-hour clock, to the nearest 10 minutes
Time Frame
Four weeks
Title
Average Comfortable Wearing Time
Description
Average comfortable wearing time was assessed by time of day when first aware of lenses using 24-hour clock, to the nearest 10 minutes.
Time Frame
Two weeks
Title
Average Comfortable Wearing Time
Description
Average comfortable wearing time was assessed by time of day when first aware of lenses using 24-hour clock, to the nearest 10 minutes.
Time Frame
Four weeks
Title
Lens Centration
Description
Lens centration will be recorded in the scale of 0 to 2 (0=centered - optimal, 1 = decentered slightly, 2 = substantially decentered (>0.5mm)).
Time Frame
Baseline (after 15 minutes)
Title
Lens Centration
Description
Lens centration will be recorded in the scale of 0 to 2 (0=centered - optimal, 1 = decentered slightly, 2 = substantially decentered (>0.5mm)).
Time Frame
Two weeks
Title
Lens Centration
Description
Lens centration will be recorded in the scale of 0 to 2 (0=centered - optimal, 1 = decentered slightly, 2 = substantially decentered (>0.5mm)).
Time Frame
Four weeks
Title
Corneal Coverage
Description
Corneal coverage (yes=full corneal coverage all times / no=incomplete corneal coverage)
Time Frame
Baseline (after 15 minutes of lens dispense)
Title
Corneal Coverage
Description
Corneal coverage (yes=full corneal coverage all times / no=incomplete corneal coverage)
Time Frame
Two weeks
Title
Corneal Coverage
Description
Corneal coverage (yes=full corneal coverage all times / no=incomplete corneal coverage)
Time Frame
Four weeks
Title
Post-Blink Movement
Description
Post-blink movement measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)
Time Frame
Baseline (after 15 minutes of lens dispense)
Title
Post-Blink Movement
Description
Post-blink movement measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)
Time Frame
Two weeks
Title
Post-Blink Movement
Description
Post-blink movement measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)
Time Frame
Four weeks
Title
Lens Tightness - Push-up Test
Description
Lens tightness - push-up test 0-100% continuous scale (100%=movement, 50%=optimum, 0%=Falls from cornea without lid support)
Time Frame
Baseline (after 15 minutes of lens dispense)
Title
Lens Tightness - Push-up Test
Description
Lens tightness - push-up test 0-100% continuous scale (100%=movement, 50%=optimum, 0%=Falls from cornea without lid support)
Time Frame
Two weeks
Title
Lens Tightness - Push-up Test
Description
Lens tightness - push-up test 0-100% continuous scale (100%=movement, 50%=optimum, 0%=Falls from cornea without lid support)
Time Frame
Four weeks
Title
Overall Lens Fit Acceptance
Description
Overall lens fit acceptance - Graded on a scale of 0-4 (0=should not be worn, 1=borderline but not acceptable, 2=minimal acceptable, 3=not perfect but OK to dispense, 4=perfect)
Time Frame
Baseline (after 15 minutes of lens dispense)
Title
Overall Lens Fit Acceptance
Description
Overall lens fit acceptance - Graded on a scale of 0-4 (0=should not be worn, 1=borderline but not acceptable, 2=minimal acceptable, 3=not perfect but OK to dispense, 4=perfect)
Time Frame
Two weeks
Title
Overall Lens Fit Acceptance
Description
Overall lens fit acceptance - Graded on a scale of 0-4 (0=should not be worn, 1=borderline but not acceptable, 2=minimal acceptable, 3=not perfect but OK to dispense, 4=perfect)
Time Frame
Four weeks
Title
Rating of Lens Surface Wettability
Description
Lens surface wettability rated on the appearance on the lens surface (0-4 scale, 0=Very poor: immediately displaying non-wetting areas on lens surface, 4=Excellent: appearance of a healthy cornea with very long drying time).
Time Frame
Baseline (after 15 minutes of lens dispense)
Title
Rating of Lens Surface Wettability
Description
Lens surface wettability rated on the appearance on the lens surface (0-4 scale, 0=Very poor: immediately displaying non-wetting areas on lens surface, 4=Excellent: appearance of a healthy cornea with very long drying time).
Time Frame
Two weeks
Title
Rating of Lens Surface Wettability
Description
Lens surface wettability rated on the appearance on the lens surface (0-4 scale, 0=Very poor: immediately displaying non-wetting areas on lens surface, 4=Excellent: appearance of a healthy cornea with very long drying time).
Time Frame
Four weeks
Title
Presence of Film Deposits
Description
Presence of film deposits on front surface of the lens graded 0-4 (0=No film, 1=Slight film visible only under magnification, 2=Moderate film only under magnification, 3=Moderate film visible to the naked eye, 4=heavy film visible to the naked eye).
Time Frame
Two weeks
Title
Presence of Film Deposits
Description
Presence of film deposits on front surface of the lens graded 0-4 (0=No film, 1=Slight film visible only under magnification, 2=Moderate film only under magnification, 3=Moderate film visible to the naked eye, 4=heavy film visible to the naked eye).
Time Frame
Four weeks
Title
Number of White Spot Deposits
Description
Number of white spot deposits assessed using slit lamp with white light, low medium magnification
Time Frame
Two weeks
Title
Number of White Spot Deposits
Description
Number of white spot deposits assessed using slit lamp with white light, low medium magnification
Time Frame
Four weeks
Title
Primary Gaze Lag
Description
Primary gaze lag measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)
Time Frame
Baseline (after 15 minutes of lens dispense)
Title
Primary Gaze Lag
Description
Primary gaze lag measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)
Time Frame
Two weeks
Title
Primary Gaze Lag
Description
Primary gaze lag measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)
Time Frame
Four weeks
Title
Comfort Throughout the Day
Description
Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses
Time Frame
Day 3 - 8:00am
Title
Comfort Throughout the Day
Description
Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses
Time Frame
Day 3 - 12:00pm
Title
Comfort Throughout the Day
Description
Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses
Time Frame
Day 3 - 4:00pm
Title
Comfort Throughout the Day
Description
Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses
Time Frame
Day 3 - 8:00pm
Title
Comfort Throughout the Day
Description
Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses
Time Frame
Day 7 - 8:00am
Title
Comfort Throughout the Day
Description
Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses
Time Frame
Day 7 - 12:00pm
Title
Comfort Throughout the Day
Description
Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses
Time Frame
Day 7 - 4:00pm
Title
Comfort Throughout the Day
Description
Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses
Time Frame
Day 7 - 8:00pm
Title
Comfort Throughout the Day
Description
Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses
Time Frame
Day 12 - 8:00am
Title
Comfort Throughout the Day
Description
Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses
Time Frame
Day 12 - 12:00pm
Title
Comfort Throughout the Day
Description
Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses
Time Frame
Day 12 - 4:00pm
Title
Comfort Throughout the Day
Description
Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses
Time Frame
Day 12 - 8:00pm
Title
Comfort Throughout the Day
Description
Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses
Time Frame
Day 26 - 8:00am
Title
Comfort Throughout the Day
Description
Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses
Time Frame
Day 26 - 12:00pm
Title
Comfort Throughout the Day
Description
Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses
Time Frame
Day 26 - 4:00pm
Title
Comfort Throughout the Day
Description
Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses
Time Frame
Day 26 - 8:00pm
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Be a currently adapted soft contact lens wearer (>1 month of lens wear).
Be at least 18 years of age.
Refractive astigmatism <1.00D in both eyes.
Have clear corneas and be free of any anterior segment disorders.
Be correctable through spherocylindrical refraction to 20/25 or better in each eye.
Contact lens sphere requirement between -1.00D and -6.00D (inclusive).
Require visual correction in both eyes (monovision allowed, no monofit).
Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
No amblyopia
No strabismus
No evidence of lid abnormality or infection
No conjunctival abnormality or infection that would contraindicate contact lens wear
No clinically significant slit lamp findings (i.e. corneal staining, stromal edema, staining, scarring, vascularization, infiltrates or abnormal opacities)
No other active ocular disease.
Own a mobile phone and be able to respond to SMS survey during the period 8am-8pm.
Willing to comply with the wear and study visit schedule.
Exclusion Criteria:
Using CooperVision Avaira Vitality, J&J Acuvue 2 or CooperVision Biomedics 55.
Require toric or multifocal contact lenses.
Previously shown a sensitivity to any of the study solution components.
Any systemic or ocular disease or allergies affecting ocular health.
Using systemic or topical medications that will in the investigator's opinion affect ocular physiology or lens performance.
Clinically significant (>Grade 3) corneal staining, corneal stromal edema, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
Any corneal infiltrates or any corneal scarring or neovascularization within the central 5mm of the cornea.
Keratoconus or other corneal irregularity.
Aphakia or amblyopia.
Have undergone corneal refractive surgery or any anterior segment surgery.
Abnormal lacrimal secretions.
Has diabetes.
Known/reported infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
History of chronic eye disease (e.g. glaucoma).
Pregnant or lactating or planning a pregnancy at the time of enrolment.
Participation in any concurrent clinical trial or in last 30 days.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David C Ardaya, OD
Organizational Affiliation
Golden Optometric Group
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William J Bogus, OD
Organizational Affiliation
Office of William J. Bogus, O.D.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bryan E Frazier, OD
Organizational Affiliation
Frazier Vision, Inc
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wayne Golden, OD
Organizational Affiliation
Golden Vision
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrew J Sacco, OD
Organizational Affiliation
Sacco Eye Group
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christopher Pearson, OD
Organizational Affiliation
Omega Vision Center PA (DBA Sabal Eye Care)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Golden Optometric Group
City
Whittier
State/Province
California
ZIP/Postal Code
90606
Country
United States
Facility Name
Omega Vision Center PA (DBA Sabal Eye Care)
City
Longwood
State/Province
Florida
ZIP/Postal Code
32779
Country
United States
Facility Name
Golden Vision
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Facility Name
Sacco Eye Group
City
Vestal
State/Province
New York
ZIP/Postal Code
13850
Country
United States
Facility Name
Frazier Vision, Inc
City
Tyler
State/Province
Texas
ZIP/Postal Code
75703
Country
United States
Facility Name
Office of William J. Bogus, O.D.
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation Of One Silicone Hydrogel Contact Lens and Two Hydrogel Lenses in Daily Wear
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