NCT03360110

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 6, 2017

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 2, 2017

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2017

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

September 2, 2020

Completed
Last Updated

September 2, 2020

Status Verified

August 1, 2020

Enrollment Period

1 month

First QC Date

November 21, 2017

Results QC Date

August 4, 2020

Last Update Submit

August 18, 2020

Conditions

Myopia

Outcome Measures

Primary Outcomes (12)

  • 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 Outcomes (6)

  • Distance Visual Acuity

    Baseline (at lens dispense)

  • Distance Visual Acuity

    Day 3

  • Near Visual Acuity

    Baseline (at dispense)

  • Near Visual Acuity

    Day 3

  • Vision Quality Rating

    Baseline (at dispense)

  • +1 more secondary outcomes

Study Arms (2)

Test lens

ACTIVE COMPARATOR

Subjects randomized to wear pair of test lens either first or second

Device: Phoebe test lensDevice: stenfilcon A lens (control)

stenfilcon A lens (control)

ACTIVE COMPARATOR

Subjects randomized to wear pair of control lens either first or second

Device: Phoebe test lensDevice: stenfilcon A lens (control)

Interventions

Phoebe test lensDEVICE

Daily disposable contact lens

Also known as: Test Lens, Phoebe Contact Lens
Test lensstenfilcon A lens (control)
stenfilcon A lens (control)DEVICE

Daily disposable contact lens

Also known as: MyDay daily disposable contact lens
Test lensstenfilcon A lens (control)

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Optical Research Lab (CORL)

Bloomington, Indiana, 47405, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Results Point of Contact

Title
Myhanh Nguyen, OD, Manager of Clinical Research
Organization
CooperVision
MNguyen@coopervision.com
19257306716

Study Officials

  • Peter S Kolbaum, O.D., Ph.D., FAAO, FBCLA

    Clinical Optics Research Lab (CORL), Indiana University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double masked (participant, investigator)
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2017

First Posted

December 2, 2017

Study Start

November 6, 2017

Primary Completion

December 15, 2017

Study Completion

December 15, 2017

Last Updated

September 2, 2020

Results First Posted

September 2, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)