Evaluation of Silicone Hydrogel Daily Wear Contact Lenses for Up to One (1) Month of Daily Wear
Primary Purpose
Myopia, Hyperopia, Astigmatism
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Invigor A (test)
Invigor B (control)
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- Be at least 18 years of age as of the date of evaluation for the study
Have
- Read the informed consent document
- Been given an explanation of the informed consent document
- indicated understanding of the informed consent document
- Signed the informed consent document
- Be willing and able to adhere to the instructions provided by the investigational site and be willing to keep all specified appointments.
- Be an adapted, frequent replacement, current full - time silicone hydrogel or soft contact lens wearer. An adapted full- time wearer is defined as wearing contact lenses at least 5 days per week for at least 8 hours per day for at least one month prior to participation in the study.
- Possess or obtain prior to dispensing, wearable and visually functional (20/40 or better) eyeglasses.
- Be in good general health, based on his/her knowledge.
Exclusion Criteria:
- Wearing lenses in a monovision modality and is unwilling to be fit with distance lenses in both eyes for the duration of the study. Note: Subjects may not wear lenses in a monovision modality at any time during the study as it will interfere with the visual acuity analysis.
- Poor personal hygiene.
- Any active participation in another clinical trial during this trial or within 30 days prior to this study.
- To the best of the subject's knowledge, she is currently pregnant, is lactating or is planning a pregnancy within the next 3 months.
- A member, relative or household member of the investigator(s) or of the investigational office staff.
- A known sensitivity to the ingredients used in the multi-purpose solution approved for use in the study and is unable or unwilling to use the alternate care system.
- Had previous refractive surgery; or current or previous orthokeratology treatment.
- Aphakic or pseudophakic.
- Ocular or systemic disease such as, but not limited to: anterior uveitis or iritis (past or present), glaucoma, Sjögren's syndrome, lupus erythematosus, scleroderma, keratoconus or uncontrolled diabetes.
- The need for topical ocular medications or any systemic medication which might interfere with contact lens wear or require the lenses to be removed during the day.
- A known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates, iritis, bacterial or fungal infections.
- A history of papillary conjunctivitis that has interfered with contact lens wear.
Sites / Locations
- Mark Nakano. O.D
- Vision Care Associates
- The Koetting Associates
- Quinn, Foster & Associates
- Primary Eyecare Group, P.C
- Ziegler Leffingwell Eye Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Invigor A (test)
Invigor B (Control)
Arm Description
Subjects will be randomized to wear Invigor A (test) for one month of daily wear during the study.
Subjects will be randomized to wear Invigor B (Control) for one month of daily wear during the study.
Outcomes
Primary Outcome Measures
Number of Eyes With Epithelial Edema - Slit Lamp Findings
Epithelial edema on slit lamp grading scale 0 - 4 (0- No microcysts; normal transparency, 1 Trace - 1 to 20 microcysts; barely discernible local epithelial haziness, 2 Mild - 21 to 50 microcysts; faint but definite localized or generalized haziness, 3 Moderate - 51 to 100 microcysts; significant localized or generalized haziness, 4 Severe - >100 microcysts; definite widespread epithelial cloudiness giving a dull glass appearance to the cornea, or numerous coalescing bullae)
Number of Eyes With Epithelial Edema - Slit Lamp Findings
Epithelial edema on slit lamp grading scale 0 - 4 (0- No microcysts; normal transparency, 1 Trace - 1 to 20 microcysts; barely discernible local epithelial haziness, 2 Mild - 21 to 50 microcysts; faint but definite localized or generalized haziness, 3 Moderate - 51 to 100 microcysts; significant localized or generalized haziness, 4 Severe - >100 microcysts; definite widespread epithelial cloudiness giving a dull glass appearance to the cornea, or numerous coalescing bullae)
Number of Eyes With Stromal Edema - Slit Lamp Findings
Stromal edema on slit lamp grading scale 0-4 (0 None - No edema, 1 Trace - Just detectable clouding, 2 Mild - faint corneal striae, 3 Moderate - Pronounced corneal striae, 4 severe - folds in Descemet's membrane and ≥4 pronounced striae
Number of Eyes With Stromal Edema - Slit Lamp Findings
Stromal edema on slit lamp grading scale 0-4 (0 None - No edema, 1 Trace - Just detectable clouding, 2 Mild - faint corneal striae, 3 Moderate - Pronounced corneal striae, 4 severe - folds in Descemet's membrane and ≥4 pronounced striae
Number of Eyes With Corneal Vascularization - Slit Lamp Findings
Corneal Vascularization on slit lamp grading scale 0-4 (0 None: No vessel penetration, 1 Trace: <1.00 mm vessel penetration, 2 Mild: >1.00 mm to <1.50 mm vessel penetration, 3 Moderate: >1.50 mm to <2.00 mm vessel penetration, 4 Severe: Vessel penetration >2.00 mm) Depth: a. - Epithelial b. - Anterior Stromal c. - Mid/Posterior Stromal Location: N - Nasal T - Temporal I - Inferior S - Superior
Number of Eyes With Corneal Vascularization - Slit Lamp Findings
Corneal Vascularization on slit lamp grading scale 0-4 (0 None: No vessel penetration, 1 Trace: <1.00 mm vessel penetration, 2 Mild: >1.00 mm to <1.50 mm vessel penetration, 3 Moderate: >1.50 mm to <2.00 mm vessel penetration, 4 Severe: Vessel penetration >2.00 mm) Depth: a. - Epithelial b. - Anterior Stromal c. - Mid/Posterior Stromal Location: N - Nasal T - Temporal I - Inferior S - Superior
Number of Eyes With Corneal Staining - Slit Lamp Findings
Corneal Staining with fluorescent on slit lamp findings - Present / Absent
Number of Eyes With Corneal Staining - Slit Lamp Findings
Corneal Staining with fluorescent on slit lamp findings - Present / Absent
Number of Eyes With Corneal Infiltrates - Slit Lamp Findings
Corneal Infiltrates on slit lamp findings - Present / Absent
Number of Eyes With Corneal Infiltrates - Slit Lamp Findings
Number of Eyes With Corneal Infiltrates on slit lamp findings - Present / Absent
Number of Eyes With Limbal Hyperemia - Slit Lamp Findings
Limbal Hyperemia on slit lamp grading scale 0-4 (0 None: No hyperemia, 1 Trace: Slight limbal hyperemia (mild segmented), 2 Mild: Mild limbal hyperemia (mild circumcorneal), 3 Moderate: Significant limbal hyperemia (marked segmented), 4 Severe: Severe limbal hyperemia (marked circumcorneal).
Number of Eyes With Limbal Hyperemia - Slit Lamp Findings
Limbal Hyperemia on slit lamp grading scale 0-4 (0 None: No hyperemia, 1 Trace: Slight limbal hyperemia (mild segmented), 2 Mild: Mild limbal hyperemia (mild circumcorneal), 3 Moderate: Significant limbal hyperemia (marked segmented), 4 Severe: Severe limbal hyperemia (marked circumcorneal).
Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings
Bulbar Hyperemia on slit lamp grading scale 0-4 (0 None: No hyperemia, 1 Trace: Slight regional hyperemia, 2 Mild: Diffuse hyperemia, 3 Moderate: Marked regional or diffuse hyperemia, 4 Severe: Diffuse episcleral or scleral hyperemia)
Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings
Bulbar Hyperemia on slit lamp grading scale 0-4 (0 None: No hyperemia, 1 Trace: Slight regional hyperemia, 2 Mild: Diffuse hyperemia, 3 Moderate: Marked regional or diffuse hyperemia, 4 Severe: Diffuse episcleral or scleral hyperemia)
Number of Eyes With Palpebral Conjunctival Observations - Slit Lamp Findings
Number of Eyes With Palpebral Conjunctival Observations on slit lamp findings - Present / Absent
Number of Eyes With Palpebral Conjunctiva - Slit Lamp Findings
Palpebral Conjunctival Observations on slit lamp findings - Present / Absent
Number of Eyes With Other Findings - Conjunctival Infection, Epidemic Keratoconjunctivitis, Corneal Ulcers, Iritis, Lens Adhesions and Recurrent Erosion - Slit Lamp Findings
Clinical entities such as conjunctival infection, epidemic keratoconjunctivitis, corneal ulcers, iritis, lens adhesions and recurrent erosion on Slit lamp grading scale of 0-4 (0 None
1 Trace, 2 Mild, 3 Moderate, 4 Severe)
Number of Eyes With Other Findings - Conjunctival Infection, Epidemic Keratoconjunctivitis, Corneal Ulcers, Iritis, Lens Adhesions and Recurrent Erosion - Slit Lamp Findings
Clinical entities such as conjunctival infection, epidemic keratoconjunctivitis, corneal ulcers, iritis, lens adhesions and recurrent erosion on Slit lamp grading scale of 0-4 (0 None
1 Trace, 2 Mild, 3 Moderate, 4 Severe)
Secondary Outcome Measures
Number of Eyes With Visual Acuity for an Effective Visual Distance of 20 Feet
Number of Eyes With Visual Acuity was assessed using Snellen VA Chart for an effective visual distance of 20 feet
Full Information
NCT ID
NCT03722784
First Posted
October 25, 2018
Last Updated
September 10, 2020
Sponsor
Coopervision, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03722784
Brief Title
Evaluation of Silicone Hydrogel Daily Wear Contact Lenses for Up to One (1) Month of Daily Wear
Official Title
Evaluation of the CooperVision, Inc. Invigor A and Invigor B Silicone Hydrogel Daily Wear Contact Lenses When Used for Frequent Replacement for Up to One (1) Month of Daily Wear
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
October 10, 2018 (Actual)
Primary Completion Date
January 18, 2019 (Actual)
Study Completion Date
June 1, 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
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study is to evaluate if the performance of Invigor A is substantially equivalent to Invigor B contact lenses when used in a one month recommended replacement, daily wear modality.
Detailed Description
This study is a multi-centered, daily wear, monthly replacement, bilateral, randomized in a ratio of two to one (2:1) Test to Control, lens blocked (subjects remain in the same lens brand throughout the study), licensed investigator and subject masked, concurrent controlled study with a study duration of approximately three months evaluating performance equivalence of Invigor A (test) over Invigor B (control) contact lenses.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Hyperopia, Astigmatism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
The subject will know the name of the lens however they will not be aware of which lens is investigational and which lens has been previously cleared. The licensed investigator has not been informed which lens is the investigational lens.
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Invigor A (test)
Arm Type
Experimental
Arm Description
Subjects will be randomized to wear Invigor A (test) for one month of daily wear during the study.
Arm Title
Invigor B (Control)
Arm Type
Active Comparator
Arm Description
Subjects will be randomized to wear Invigor B (Control) for one month of daily wear during the study.
Intervention Type
Device
Intervention Name(s)
Invigor A (test)
Intervention Description
silicone hydrogel lens
Intervention Type
Device
Intervention Name(s)
Invigor B (control)
Intervention Description
silicone hydrogel lens
Primary Outcome Measure Information:
Title
Number of Eyes With Epithelial Edema - Slit Lamp Findings
Description
Epithelial edema on slit lamp grading scale 0 - 4 (0- No microcysts; normal transparency, 1 Trace - 1 to 20 microcysts; barely discernible local epithelial haziness, 2 Mild - 21 to 50 microcysts; faint but definite localized or generalized haziness, 3 Moderate - 51 to 100 microcysts; significant localized or generalized haziness, 4 Severe - >100 microcysts; definite widespread epithelial cloudiness giving a dull glass appearance to the cornea, or numerous coalescing bullae)
Time Frame
Baseline
Title
Number of Eyes With Epithelial Edema - Slit Lamp Findings
Description
Epithelial edema on slit lamp grading scale 0 - 4 (0- No microcysts; normal transparency, 1 Trace - 1 to 20 microcysts; barely discernible local epithelial haziness, 2 Mild - 21 to 50 microcysts; faint but definite localized or generalized haziness, 3 Moderate - 51 to 100 microcysts; significant localized or generalized haziness, 4 Severe - >100 microcysts; definite widespread epithelial cloudiness giving a dull glass appearance to the cornea, or numerous coalescing bullae)
Time Frame
One Month
Title
Number of Eyes With Stromal Edema - Slit Lamp Findings
Description
Stromal edema on slit lamp grading scale 0-4 (0 None - No edema, 1 Trace - Just detectable clouding, 2 Mild - faint corneal striae, 3 Moderate - Pronounced corneal striae, 4 severe - folds in Descemet's membrane and ≥4 pronounced striae
Time Frame
Baseline
Title
Number of Eyes With Stromal Edema - Slit Lamp Findings
Description
Stromal edema on slit lamp grading scale 0-4 (0 None - No edema, 1 Trace - Just detectable clouding, 2 Mild - faint corneal striae, 3 Moderate - Pronounced corneal striae, 4 severe - folds in Descemet's membrane and ≥4 pronounced striae
Time Frame
One Month
Title
Number of Eyes With Corneal Vascularization - Slit Lamp Findings
Description
Corneal Vascularization on slit lamp grading scale 0-4 (0 None: No vessel penetration, 1 Trace: <1.00 mm vessel penetration, 2 Mild: >1.00 mm to <1.50 mm vessel penetration, 3 Moderate: >1.50 mm to <2.00 mm vessel penetration, 4 Severe: Vessel penetration >2.00 mm) Depth: a. - Epithelial b. - Anterior Stromal c. - Mid/Posterior Stromal Location: N - Nasal T - Temporal I - Inferior S - Superior
Time Frame
Baseline
Title
Number of Eyes With Corneal Vascularization - Slit Lamp Findings
Description
Corneal Vascularization on slit lamp grading scale 0-4 (0 None: No vessel penetration, 1 Trace: <1.00 mm vessel penetration, 2 Mild: >1.00 mm to <1.50 mm vessel penetration, 3 Moderate: >1.50 mm to <2.00 mm vessel penetration, 4 Severe: Vessel penetration >2.00 mm) Depth: a. - Epithelial b. - Anterior Stromal c. - Mid/Posterior Stromal Location: N - Nasal T - Temporal I - Inferior S - Superior
Time Frame
One Month
Title
Number of Eyes With Corneal Staining - Slit Lamp Findings
Description
Corneal Staining with fluorescent on slit lamp findings - Present / Absent
Time Frame
Baseline
Title
Number of Eyes With Corneal Staining - Slit Lamp Findings
Description
Corneal Staining with fluorescent on slit lamp findings - Present / Absent
Time Frame
One Month
Title
Number of Eyes With Corneal Infiltrates - Slit Lamp Findings
Description
Corneal Infiltrates on slit lamp findings - Present / Absent
Time Frame
Baseline
Title
Number of Eyes With Corneal Infiltrates - Slit Lamp Findings
Description
Number of Eyes With Corneal Infiltrates on slit lamp findings - Present / Absent
Time Frame
One Month
Title
Number of Eyes With Limbal Hyperemia - Slit Lamp Findings
Description
Limbal Hyperemia on slit lamp grading scale 0-4 (0 None: No hyperemia, 1 Trace: Slight limbal hyperemia (mild segmented), 2 Mild: Mild limbal hyperemia (mild circumcorneal), 3 Moderate: Significant limbal hyperemia (marked segmented), 4 Severe: Severe limbal hyperemia (marked circumcorneal).
Time Frame
Baseline
Title
Number of Eyes With Limbal Hyperemia - Slit Lamp Findings
Description
Limbal Hyperemia on slit lamp grading scale 0-4 (0 None: No hyperemia, 1 Trace: Slight limbal hyperemia (mild segmented), 2 Mild: Mild limbal hyperemia (mild circumcorneal), 3 Moderate: Significant limbal hyperemia (marked segmented), 4 Severe: Severe limbal hyperemia (marked circumcorneal).
Time Frame
One Month
Title
Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings
Description
Bulbar Hyperemia on slit lamp grading scale 0-4 (0 None: No hyperemia, 1 Trace: Slight regional hyperemia, 2 Mild: Diffuse hyperemia, 3 Moderate: Marked regional or diffuse hyperemia, 4 Severe: Diffuse episcleral or scleral hyperemia)
Time Frame
Baseline
Title
Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings
Description
Bulbar Hyperemia on slit lamp grading scale 0-4 (0 None: No hyperemia, 1 Trace: Slight regional hyperemia, 2 Mild: Diffuse hyperemia, 3 Moderate: Marked regional or diffuse hyperemia, 4 Severe: Diffuse episcleral or scleral hyperemia)
Time Frame
One Month
Title
Number of Eyes With Palpebral Conjunctival Observations - Slit Lamp Findings
Description
Number of Eyes With Palpebral Conjunctival Observations on slit lamp findings - Present / Absent
Time Frame
Baseline
Title
Number of Eyes With Palpebral Conjunctiva - Slit Lamp Findings
Description
Palpebral Conjunctival Observations on slit lamp findings - Present / Absent
Time Frame
One Month
Title
Number of Eyes With Other Findings - Conjunctival Infection, Epidemic Keratoconjunctivitis, Corneal Ulcers, Iritis, Lens Adhesions and Recurrent Erosion - Slit Lamp Findings
Description
Clinical entities such as conjunctival infection, epidemic keratoconjunctivitis, corneal ulcers, iritis, lens adhesions and recurrent erosion on Slit lamp grading scale of 0-4 (0 None
1 Trace, 2 Mild, 3 Moderate, 4 Severe)
Time Frame
Baseline
Title
Number of Eyes With Other Findings - Conjunctival Infection, Epidemic Keratoconjunctivitis, Corneal Ulcers, Iritis, Lens Adhesions and Recurrent Erosion - Slit Lamp Findings
Description
Clinical entities such as conjunctival infection, epidemic keratoconjunctivitis, corneal ulcers, iritis, lens adhesions and recurrent erosion on Slit lamp grading scale of 0-4 (0 None
1 Trace, 2 Mild, 3 Moderate, 4 Severe)
Time Frame
One Month
Secondary Outcome Measure Information:
Title
Number of Eyes With Visual Acuity for an Effective Visual Distance of 20 Feet
Description
Number of Eyes With Visual Acuity was assessed using Snellen VA Chart for an effective visual distance of 20 feet
Time Frame
One Month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Be at least 18 years of age as of the date of evaluation for the study
Have
Read the informed consent document
Been given an explanation of the informed consent document
indicated understanding of the informed consent document
Signed the informed consent document
Be willing and able to adhere to the instructions provided by the investigational site and be willing to keep all specified appointments.
Be an adapted, frequent replacement, current full - time silicone hydrogel or soft contact lens wearer. An adapted full- time wearer is defined as wearing contact lenses at least 5 days per week for at least 8 hours per day for at least one month prior to participation in the study.
Possess or obtain prior to dispensing, wearable and visually functional (20/40 or better) eyeglasses.
Be in good general health, based on his/her knowledge.
Exclusion Criteria:
Wearing lenses in a monovision modality and is unwilling to be fit with distance lenses in both eyes for the duration of the study. Note: Subjects may not wear lenses in a monovision modality at any time during the study as it will interfere with the visual acuity analysis.
Poor personal hygiene.
Any active participation in another clinical trial during this trial or within 30 days prior to this study.
To the best of the subject's knowledge, she is currently pregnant, is lactating or is planning a pregnancy within the next 3 months.
A member, relative or household member of the investigator(s) or of the investigational office staff.
A known sensitivity to the ingredients used in the multi-purpose solution approved for use in the study and is unable or unwilling to use the alternate care system.
Had previous refractive surgery; or current or previous orthokeratology treatment.
Aphakic or pseudophakic.
Ocular or systemic disease such as, but not limited to: anterior uveitis or iritis (past or present), glaucoma, Sjögren's syndrome, lupus erythematosus, scleroderma, keratoconus or uncontrolled diabetes.
The need for topical ocular medications or any systemic medication which might interfere with contact lens wear or require the lenses to be removed during the day.
A known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates, iritis, bacterial or fungal infections.
A history of papillary conjunctivitis that has interfered with contact lens wear.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Quinn, O.D
Organizational Affiliation
Quinn, Foster & Associates, OH
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Van Hoven, O.D
Organizational Affiliation
Primary Eyecare group, P.C, TN
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Nakano, O.D
Organizational Affiliation
Mark Nakano, O.D, CA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Ziegler, O.D
Organizational Affiliation
Ziegler Leffingwell Eye Center, WI
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cheryl Vincent Riemer, O.D
Organizational Affiliation
Vision Care Associates, MI
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carmen Castellano, O.D
Organizational Affiliation
The Koetting Associates, MO
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mark Nakano. O.D
City
Torrance
State/Province
California
ZIP/Postal Code
90503
Country
United States
Facility Name
Vision Care Associates
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48823
Country
United States
Facility Name
The Koetting Associates
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63144
Country
United States
Facility Name
Quinn, Foster & Associates
City
Athens
State/Province
Ohio
ZIP/Postal Code
45701
Country
United States
Facility Name
Primary Eyecare Group, P.C
City
Brentwood
State/Province
Tennessee
ZIP/Postal Code
37027-7552
Country
United States
Facility Name
Ziegler Leffingwell Eye Center
City
West Allis
State/Province
Wisconsin
ZIP/Postal Code
53227
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Silicone Hydrogel Daily Wear Contact Lenses for Up to One (1) Month of Daily Wear
We'll reach out to this number within 24 hrs