Comparison of New Contact Lens With Current Marketed Lens

Clinical Validation Study of Phoebe Lens

The purpose of this study is to validate the clinical performance of a new contact lens design.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Phoebe test lens; Device: stenfilcon A lens (control)

Detailed Description

Evaluate the clinical performance of its Phoebe contact lenses (Test) compared to the commercially available MyDay contact lenses (Control).

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Bloomington, Indiana, United States, 47405
      • Clinical Optical Research Lab (CORL)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria

A person is eligible for inclusion in the study if he/she:

• Between and 18 and 35 years of age and has full legal capacity to volunteer
• Has had a self-reported oculo-visual examination in the last two years
• Has read and understood the information consent letter
• Is willing and able to follow instructions and maintain the appointment schedule
• Is correctable to a visual acuity of 20/25 or better (in each eye) with their habitual correction or 20/20 best corrected
• Has a Contact Lens Refraction between -1.00D and -6.00D
• Cylinder power ≤ -0.75DC in Spherical Cylindrical Refraction
• Currently wears soft contact lenses
• Is willing to wear lenses for a minimal of 8 hours a day and everyday during the course of the study
• Has clear corneas and no active ocular disease
• Has not worn lenses for at least 12 hours before the first visit

Exclusion Criteria

A person will be excluded from the study if he/she:

• Has never worn contact lenses before
• Is wearing Monovision modality
• Has any systemic disease affecting ocular health
• Is using any systemic or topical medications that will affect ocular health
• Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses
• Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye
• Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars
• Is aphakic
• Has undergone corneal refractive surgery
• Is participating in any other type of eye related clinical or research study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Test lens; Subjects randomized to wear pair of test lens either first or second	Device: Phoebe test lens; Daily disposable contact lens; Other Names: Test Lens; Phoebe Contact Lens; Device: stenfilcon A lens (control); Daily disposable contact lens; Other Names: MyDay daily disposable contact lens
ACTIVE_COMPARATOR: stenfilcon A lens (control); Subjects randomized to wear pair of control lens either first or second	Device: Phoebe test lens; Daily disposable contact lens; Other Names: Test Lens; Phoebe Contact Lens; Device: stenfilcon A lens (control); Daily disposable contact lens; Other Names: MyDay daily disposable contact lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corneal Staining Extent	Measurement of extent of corneal staining using Fluorescein, blue light, yellow filter, full beam, medium magnification on a scale 0-4 (0=no staining, 1 = 1-15% of area, 2= 16-30% of area, 3=31-45% of area, 4=>45% of area).	Baseline
Corneal Staining Extent	Measurement of extent of corneal staining using Fluorescein, blue light, yellow filter, full beam, medium magnification on a scale 0-4 (0=no staining, 1 = 1-15% of area, 2= 16-30% of area, 3=31-45% of area, 4=>45% of area).	Day 3
Conjunctival Staining Score	Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=Deep Confluent, in 0.50 steps	Baseline
Conjunctival Staining Score	Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=Deep Confluent, in 0.50 steps	Day 3
Palpebral Hyperemia on Upper Lid	Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps	Baseline
Palpebral Hyperemia on Upper Lid	Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps	Day 3
Palpebral Hyperemia on Lower Lid	Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps	Baseline
Palpebral Hyperemia on Lower Lid	Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps	Day 3
Palpebral Roughness Grade - Upper Lid	Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps	Baseline
Palpebral Roughness Grade - Upper Lid	Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps	Day 3
Palpebral Roughness Grade - Lower Lid	Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps	Baseline
Palpebral Roughness Grade - Lower Lid	Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps	Day 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance Visual Acuity	Distance visual acuity recorded in logMAR.	Baseline (at lens dispense)
Distance Visual Acuity	Distance visual acuity recorded in logMAR.	Day 3
Near Visual Acuity	Near visual acuity recorded in logMAR	Baseline (at dispense)
Near Visual Acuity	Near visual acuity recorded in logMAR	Day 3
Vision Quality Rating	Subjective vision quality rated on a 0-10 scale (0=extremely poor, 10=excellent)	Baseline (at dispense)
Vision Quality Rating	Subjective vision quality rated on a 0-10 scale (0=extremely poor, 10=excellent)	Day 3

Collaborators and Investigators

• Sponsor: Coopervision, Inc.
• Investigators: Principal Investigator: Peter S Kolbaum, O.D., Ph.D., FAAO, FBCLA, Clinical Optics Research Lab (CORL), Indiana University

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 6, 2017
• Primary Completion (ACTUAL): December 15, 2017
• Study Completion (ACTUAL): December 15, 2017

Study Registration Dates

• First Submitted: November 21, 2017
• First Submitted That Met QC Criteria: November 27, 2017
• First Posted (ACTUAL): December 2, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 2, 2020
• Last Update Submitted That Met QC Criteria: August 18, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CV-17-60

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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