Skip to main content
OpenTrials
Completed

NCT Number: NCT02436005

Dispensing Study for the Phenacite Project

Dispensing Study for the Phenacite Project.

The investigational test lens was not the final optical design and the study was not used for design validation.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ametropia Eye Diseases Refractive Errors

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University

Bloomington, Indiana, 47405, United States

About this study

Evaluate the objective and patient-reported visual acceptability of the Phenacite contact lens.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Oculo-visual examination in the last two years
  • Between 18 and 35 years of age and has full legal capacity to volunteer
  • Has read and understood the informed 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
  • Currently wears, or has previously successfully worn, soft contact lenses between -1.00D and -4.00D
  • Spherical Contact Lens Rx between -1.00 and -4.00 and spectacle cylinder ≤-0.75
  • Has not worn lenses for at least 12 hours before the initial visit
  • Has a subjective response at baseline, which indicates suitability for this study
  • Currently spends a minimum of 4 hours a day; 5 days a week on digital devices and can replicate this time during the study period
  • Is willing and able to wear the study contact lenses a minimum of 10 hours per day; 5 days a week.

Exclusion criteria

  • Has never worn contact lenses before
  • Any systemic disease affecting ocular health
  • Is using any systemic or topical medications that will affect ocular health
  • Has known sensitivity to the diagnostic pharmaceuticals or study products used in this study.
  • Has any ocular pathology or anomaly that would affect the wearing of the lenses
  • Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye
  • Is aphakic
  • Has anisometropia of >1.00
  • Has undergone corneal refractive surgery
  • Has strabismus
  • Has any ocular amblyopia >= 1line of HC Visual Acuity
  • Is participating in any other type of eye related clinical or research study
  • Has participated in study CV-14-32.

Treatment and study plan

Phenacite

Device

Subjects will be randomized to wear the Phenacite contact lenses binocularly.

comfilcon A

Device

Subjects will be randomized to wear the comfilcon A contact lenses binocularly.

Primary outcomes

  1. Subjective Ratings of Lens Comfort

    Time frame: Baseline (after 15 minutes of lens dispense)

    Subjective ratings of lens comfort. Comfort Scale (0,100; 0=extremely uncomfortable/cannot tolerate; 100 = extremely comfortable/cannot be felt)

  2. Subjective Ratings of Lens Comfort

    Time frame: 2 Weeks

    Subjective ratings of lens comfort. Comfort Scale (0,100; 0=extremely uncomfortable/cannot tolerate; 100 = extremely comfortable/cannot be felt)

  3. Over Refraction for Optimized Distance Acuity

    Time frame: 2 weeks

    Over Refraction for optimized distance acuity measured using logMAR

  4. Binocular Distance Visual Acuity - High Illumination High Contrast

    Time frame: Baseline (after 5 minutes of lens dispense)

    Binocular Distance Visual Acuity - High Illumination High Contrast was measured using logMAR

  5. Binocular Distance Visual Acuity - High Illumination High Contrast

    Time frame: 2 weeks

    Binocular Distance Visual Acuity - High Illumination High Contrast was measured using logMAR

  6. Binocular Distance Visual Acuity - Low Illumination High Contrast

    Time frame: Baseline (after 5 minutes of lens dispense)

    Binocular Distance Visual Acuity - Low Illumination High Contrast was measured using logMAR

  7. Binocular Distance Visual Acuity - Low Illumination High Contrast

    Time frame: 2 weeks

    Binocular Distance Visual Acuity - Low Illumination High Contrast was measured using logMAR

  8. Binocular Near Visual Acuity - High Illumination High Contrast

    Time frame: Baseline (after 5 minutes of lens dispense)

    Binocular Near Visual Acuity - High Illumination High Contrast was measured using logMAR

  9. Binocular Near Visual Acuity - High Illumination High Contrast

    Time frame: 2 weeks

    Binocular Near Visual Acuity - High Illumination High Contrast was measured using logMAR

  10. Binocular Near Visual Acuity - Low Illumination High Contrast

    Time frame: Baseline (after 5 minutes of lens dispense)

    Binocular Near Visual Acuity - Low Illumination High Contrast was measured using logMAR

  11. Binocular Near Visual Acuity - Low Illumination High Contrast

    Time frame: 2 weeks

    Binocular Near Visual Acuity - Low Illumination High Contrast was measured using logMAR

Secondary outcomes

  1. Lens Fit - Post Blink Movement

    Time frame: Baseline (after 15 minutes of lens dispense)

    Investigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)

  2. Lens Fit - Post Blink Movement

    Time frame: 2 weeks

    Investigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)

  3. Push - Up Test for Lens Tightness

    Time frame: Baseline (after 15 minutes of lens dispense)

    Investigator assessment using Continuous Scale 0-100% (1% steps): 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement

  4. Push - Up Test for Lens Tightness

    Time frame: 2 weeks

    Investigator assessment using Continuous Scale 0-100% (1% steps): 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement

  5. Lens Mobility Rating

    Time frame: Baseline (after 15 minutes of lens dispense)

    Investigator assessment using 5 Categories in 0.50 steps: 0=Immobile - no lag in any versions, 1=Restricted - no lag in some directions but slight lag (0-0.25mm) in others, 2=Secure - slight lag (0.25-0.5mm in each version), 3=Unrestricted - freely lags in a controlled manner on all versions, but not excessive (0.5-1.0mm), 4=Very mobile - excessive lag (>1mm) on versions in all directions in 0.25 steps

  6. Lens Mobility Rating

    Time frame: 2 weeks

    Investigator assessment using 5 Categories in 0.50 steps: 0=Immobile - no lag in any versions, 1=Restricted - no lag in some directions but slight lag (0-0.25mm) in others, 2=Secure - slight lag (0.25-0.5mm in each version), 3=Unrestricted - freely lags in a controlled manner on all versions, but not excessive (0.5-1.0mm), 4=Very mobile - excessive lag (>1mm) on versions in all directions in 0.25 steps

  7. Overall Lens Fit Acceptance

    Time frame: Baseline (after 15 minutes of lens dispense)

    Investigator assessment using 5 Categories in 0.25 steps: 0=Can't be worn, 1=Poor - should not be dispensed although no immediate danger, 2=Fair, 3=Good, 4=Optimum in 0.25 steps

  8. Overall Lens Fit Acceptance

    Time frame: 2 weeks

    Investigator assessment using 5 Categories in 0.25 steps: 0=Can't be worn, 1=Poor - should not be dispensed although no immediate danger, 2=Fair, 3=Good, 4=Optimum in 0.25 steps

  9. Subjective Ratings for Vision Quality - Distance Vision

    Time frame: Baseline (after 15 minutes of lens dispense)

    Patient subjective scoring using 0-100 continuous scale for Distance Quality of Vision: 0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time

  10. Subjective Ratings for Vision Quality - Distance Vision

    Time frame: 2 weeks

    Patient subjective scoring using 0-100 continuous scale for Distance Quality of Vision: 0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time

  11. Subjective Ratings for Vision Quality - Near Vision

    Time frame: Baseline (after 15 minutes of lens dispense)

    Patient subjective scoring using 0-100 continuous scale for Near Quality of Vision: 0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time

  12. Subjective Ratings for Vision Quality - Near Vision

    Time frame: 2 weeks

    Patient subjective scoring using 0-100 continuous scale for Near Quality of Vision: 0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time

  13. Subjective Ratings for Vision Quality - Computer Vision

    Time frame: Baseline (after 15 minutes of lens dispense)

    Patient subjective scoring using 0-100 continuous scale for Computer Vision: 0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time

  14. Subjective Ratings for Vision Quality - Computer Vision

    Time frame: 2 weeks

    Patient subjective scoring using 0-100 continuous scale for Computer Vision: 0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time

  15. Subjective Ratings for Vision Quality - Overall Vision

    Time frame: Baseline (after 15 minutes of lens dispense)

    Patient subjective scoring using 0-100 continuous scale for Overall Vision: 0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time

  16. Subjective Ratings for Vision Quality - Overall Vision

    Time frame: 2 weeks

    Patient subjective scoring using 0-100 continuous scale for Overall Vision: 0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time

  17. Corneal Staining Extent

    Time frame: 2 weeks

    Corneal staining extent was assessed on a scale of 0-4 (0-No Staining, 1 - 1-15% of area, 2- 16-30% of area, 3- 31-45% of area, 4- >45% of area

  18. Conjunctival Staining

    Time frame: 2 weeks

    Conjunctival staining was assessed on a scale of 0-4, 0.50 steps (0-None, 1 - Minimal diffuse punctuate, 2- Coalescent Punctuate, 3- confluent, 4- Deep confluent

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
May 6, 2015
Registry last updated
Nov 18, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.