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.

Study Overview

• Status: Completed
• Conditions: Ametropia
• Intervention / Treatment: Device: Phenacite; Device: comfilcon A

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Bloomington, Indiana, United States, 47405
      • Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University

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:

• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phenacite; Subjects will be randomized to wear the Phenacite contact lenses binocularly.	Device: Phenacite; Subjects will be randomized to wear the Phenacite contact lenses binocularly.; Device: comfilcon A; Subjects will be randomized to wear the comfilcon A contact lenses binocularly.
Active Comparator: comfilcon A; Subjects will be randomized to wear the comfilcon A contact lenses binocularly.	Device: Phenacite; Subjects will be randomized to wear the Phenacite contact lenses binocularly.; Device: comfilcon A; Subjects will be randomized to wear the comfilcon A contact lenses binocularly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Ratings of Lens Comfort	Subjective ratings of lens comfort. Comfort Scale (0,100; 0=extremely uncomfortable/cannot tolerate; 100 = extremely comfortable/cannot be felt)	Baseline (after 15 minutes of lens dispense)
Subjective Ratings of Lens Comfort	Subjective ratings of lens comfort. Comfort Scale (0,100; 0=extremely uncomfortable/cannot tolerate; 100 = extremely comfortable/cannot be felt)	2 Weeks
Over Refraction for Optimized Distance Acuity	Over Refraction for optimized distance acuity measured using logMAR	2 weeks
Binocular Distance Visual Acuity - High Illumination High Contrast	Binocular Distance Visual Acuity - High Illumination High Contrast was measured using logMAR	Baseline (after 5 minutes of lens dispense)
Binocular Distance Visual Acuity - High Illumination High Contrast	Binocular Distance Visual Acuity - High Illumination High Contrast was measured using logMAR	2 weeks
Binocular Distance Visual Acuity - Low Illumination High Contrast	Binocular Distance Visual Acuity - Low Illumination High Contrast was measured using logMAR	Baseline (after 5 minutes of lens dispense)
Binocular Distance Visual Acuity - Low Illumination High Contrast	Binocular Distance Visual Acuity - Low Illumination High Contrast was measured using logMAR	2 weeks
Binocular Near Visual Acuity - High Illumination High Contrast	Binocular Near Visual Acuity - High Illumination High Contrast was measured using logMAR	Baseline (after 5 minutes of lens dispense)
Binocular Near Visual Acuity - High Illumination High Contrast	Binocular Near Visual Acuity - High Illumination High Contrast was measured using logMAR	2 weeks
Binocular Near Visual Acuity - Low Illumination High Contrast	Binocular Near Visual Acuity - Low Illumination High Contrast was measured using logMAR	Baseline (after 5 minutes of lens dispense)
Binocular Near Visual Acuity - Low Illumination High Contrast	Binocular Near Visual Acuity - Low Illumination High Contrast was measured using logMAR	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lens Fit - Post Blink Movement	Investigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)	Baseline (after 15 minutes of lens dispense)
Lens Fit - Post Blink Movement	Investigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)	2 weeks
Push - Up Test for Lens Tightness	Investigator assessment using Continuous Scale 0-100% (1% steps): 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement	Baseline (after 15 minutes of lens dispense)
Push - Up Test for Lens Tightness	Investigator assessment using Continuous Scale 0-100% (1% steps): 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement	2 weeks
Lens Mobility Rating	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	Baseline (after 15 minutes of lens dispense)
Lens Mobility Rating	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	2 weeks
Overall Lens Fit Acceptance	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	Baseline (after 15 minutes of lens dispense)
Overall Lens Fit Acceptance	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	2 weeks
Subjective Ratings for Vision Quality - Distance Vision	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	Baseline (after 15 minutes of lens dispense)
Subjective Ratings for Vision Quality - Distance Vision	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	2 weeks
Subjective Ratings for Vision Quality - Near Vision	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	Baseline (after 15 minutes of lens dispense)
Subjective Ratings for Vision Quality - Near Vision	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	2 weeks
Subjective Ratings for Vision Quality - Computer Vision	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	Baseline (after 15 minutes of lens dispense)
Subjective Ratings for Vision Quality - Computer Vision	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	2 weeks
Subjective Ratings for Vision Quality - Overall Vision	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	Baseline (after 15 minutes of lens dispense)
Subjective Ratings for Vision Quality - Overall Vision	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	2 weeks
Corneal Staining Extent	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	2 weeks
Conjunctival Staining	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	2 weeks

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Investigators: Principal Investigator: Pete Kollbaun, OD PhD, CORL Indiana University

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: May 1, 2015
• First Submitted That Met QC Criteria: May 1, 2015
• First Posted (Estimate): May 6, 2015

Study Record Updates

• Last Update Posted (Actual): November 18, 2020
• Last Update Submitted That Met QC Criteria: October 30, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: CV-15-16

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes