Evaluation of Silicone Hydrogel Daily Wear Contact Lenses for Up to One (1) Month of Daily Wear

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

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.

Study Overview

• Status: Completed
• Conditions: Astigmatism; Myopia; Hyperopia
• Intervention / Treatment: Device: Invigor A (test); Device: Invigor B (control)

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.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Torrance, California, United States, 90503
      • Mark Nakano. O.D
  • Michigan
    • East Lansing, Michigan, United States, 48823
      • Vision Care Associates
  • Missouri
    • Saint Louis, Missouri, United States, 63144
      • The Koetting Associates
  • Ohio
    • Athens, Ohio, United States, 45701
      • Quinn, Foster & Associates
  • Tennessee
    • Brentwood, Tennessee, United States, 37027-7552
      • Primary Eyecare Group, P.C
  • Wisconsin
    • West Allis, Wisconsin, United States, 53227
      • Ziegler Leffingwell Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

• Inclusion Criteria:

  1. Be at least 18 years of age as of the date of evaluation for the study

  2. Have

     1. Read the informed consent document
     2. Been given an explanation of the informed consent document
     3. indicated understanding of the informed consent document
     4. Signed the informed consent document
  3. Be willing and able to adhere to the instructions provided by the investigational site and be willing to keep all specified appointments.
  4. 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.
  5. Possess or obtain prior to dispensing, wearable and visually functional (20/40 or better) eyeglasses.
  6. Be in good general health, based on his/her knowledge.

• Exclusion Criteria:

  1. 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.
  2. Poor personal hygiene.
  3. Any active participation in another clinical trial during this trial or within 30 days prior to this study.
  4. To the best of the subject's knowledge, she is currently pregnant, is lactating or is planning a pregnancy within the next 3 months.
  5. A member, relative or household member of the investigator(s) or of the investigational office staff.
  6. 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.
  7. Had previous refractive surgery; or current or previous orthokeratology treatment.
  8. Aphakic or pseudophakic.
  9. 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.
  10. 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.
  11. A known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates, iritis, bacterial or fungal infections.
  12. A history of papillary conjunctivitis that has interfered with contact lens wear.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Invigor A (test); Subjects will be randomized to wear Invigor A (test) for one month of daily wear during the study.	Device: Invigor A (test); silicone hydrogel lens
Active Comparator: Invigor B (Control); Subjects will be randomized to wear Invigor B (Control) for one month of daily wear during the study.	Device: Invigor B (control); silicone hydrogel lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Baseline
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)	One Month
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	Baseline
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	One Month
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	Baseline
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	One Month
Number of Eyes With Corneal Staining - Slit Lamp Findings	Corneal Staining with fluorescent on slit lamp findings - Present / Absent	Baseline
Number of Eyes With Corneal Staining - Slit Lamp Findings	Corneal Staining with fluorescent on slit lamp findings - Present / Absent	One Month
Number of Eyes With Corneal Infiltrates - Slit Lamp Findings	Corneal Infiltrates on slit lamp findings - Present / Absent	Baseline
Number of Eyes With Corneal Infiltrates - Slit Lamp Findings	Number of Eyes With Corneal Infiltrates on slit lamp findings - Present / Absent	One Month
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).	Baseline
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).	One Month
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)	Baseline
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)	One Month
Number of Eyes With Palpebral Conjunctival Observations - Slit Lamp Findings	Number of Eyes With Palpebral Conjunctival Observations on slit lamp findings - Present / Absent	Baseline
Number of Eyes With Palpebral Conjunctiva - Slit Lamp Findings	Palpebral Conjunctival Observations on slit lamp findings - Present / Absent	One Month
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)	Baseline
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)	One Month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	One Month

Collaborators and Investigators

• Sponsor: Coopervision, Inc.
• Investigators: Principal Investigator: Thomas Quinn, O.D, Quinn, Foster & Associates, OH; Principal Investigator: Peter Van Hoven, O.D, Primary Eyecare group, P.C, TN; Principal Investigator: Mark Nakano, O.D, Mark Nakano, O.D, CA; Principal Investigator: David Ziegler, O.D, Ziegler Leffingwell Eye Center, WI; Principal Investigator: Cheryl Vincent Riemer, O.D, Vision Care Associates, MI; Principal Investigator: Carmen Castellano, O.D, The Koetting Associates, MO

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2018
• Primary Completion (Actual): January 18, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: October 25, 2018
• First Submitted That Met QC Criteria: October 25, 2018
• First Posted (Actual): October 29, 2018

Study Record Updates

• Last Update Posted (Actual): October 1, 2020
• Last Update Submitted That Met QC Criteria: September 10, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism; Hyperopia
• Other Study ID Numbers: FC160322

Drug and device information, study documents

• 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