Dispensing Study for the Phenacite Project

CooperVision, Inc.25 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Ametropia

Interventions

PhenaciteDEVICE

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

comfilcon ADEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 35 Years

Medical Language ↔ Plain English

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.

Locations (1)

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

Bloomington, Indiana, United States

Outcomes

Primary Outcomes

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)

Time frame: 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)

Time frame: 2 Weeks

Over Refraction for Optimized Distance Acuity

Over Refraction for optimized distance acuity measured using logMAR

Time frame: 2 weeks

Binocular Distance Visual Acuity - High Illumination High Contrast

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

Time frame: 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

Time frame: 2 weeks

Binocular Distance Visual Acuity - Low Illumination High Contrast

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

Time frame: 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

Time frame: 2 weeks

Binocular Near Visual Acuity - High Illumination High Contrast

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

Lens Fit - Post Blink Movement

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

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: 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

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

Lens Mobility Rating

Time frame: 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

Time frame: 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

Time frame: 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

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

Subjective Ratings for Vision Quality - Distance Vision

Time frame: 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

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

Subjective Ratings for Vision Quality - Near Vision

Time frame: 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

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

Subjective Ratings for Vision Quality - Computer Vision

Time frame: 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

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

Subjective Ratings for Vision Quality - Overall Vision

Time frame: 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

Time frame: 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

Time frame: 2 weeks