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OpenTrials
Completed

NCT Number: NCT03360110

Comparison of New Contact Lens With Current Marketed Lens

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

Completed

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Optical Research Lab (CORL)

Bloomington, Indiana, 47405, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phoebe test lens

Device

Daily disposable contact lens

Other names: Test Lens, Phoebe Contact Lens

stenfilcon A lens (control)

Device

Daily disposable contact lens

Other names: MyDay daily disposable contact lens

Primary outcomes

  1. Corneal Staining Extent

    Time frame: Baseline

    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).

  2. Corneal Staining Extent

    Time frame: Day 3

    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).

  3. Conjunctival Staining Score

    Time frame: Baseline

    Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=Deep Confluent, in 0.50 steps

  4. Conjunctival Staining Score

    Time frame: Day 3

    Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=Deep Confluent, in 0.50 steps

  5. Palpebral Hyperemia on Upper Lid

    Time frame: Baseline

    Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps

  6. Palpebral Hyperemia on Upper Lid

    Time frame: Day 3

    Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps

  7. Palpebral Hyperemia on Lower Lid

    Time frame: Baseline

    Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps

  8. Palpebral Hyperemia on Lower Lid

    Time frame: Day 3

    Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps

  9. Palpebral Roughness Grade - Upper Lid

    Time frame: Baseline

    Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps

  10. Palpebral Roughness Grade - Upper Lid

    Time frame: Day 3

    Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps

  11. Palpebral Roughness Grade - Lower Lid

    Time frame: Baseline

    Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps

  12. Palpebral Roughness Grade - Lower Lid

    Time frame: Day 3

    Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps

Secondary outcomes

  1. Distance Visual Acuity

    Time frame: Baseline (at lens dispense)

    Distance visual acuity recorded in logMAR.

  2. Distance Visual Acuity

    Time frame: Day 3

    Distance visual acuity recorded in logMAR.

  3. Near Visual Acuity

    Time frame: Baseline (at dispense)

    Near visual acuity recorded in logMAR

  4. Near Visual Acuity

    Time frame: Day 3

    Near visual acuity recorded in logMAR

  5. Vision Quality Rating

    Time frame: Baseline (at dispense)

    Subjective vision quality rated on a 0-10 scale (0=extremely poor, 10=excellent)

  6. Vision Quality Rating

    Time frame: Day 3

    Subjective vision quality rated on a 0-10 scale (0=extremely poor, 10=excellent)

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Official study title

Clinical Validation Study of Phoebe Lens

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Dec 2, 2017
Registry last updated
Sep 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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