Dispensing Study for the Phenacite Project

Not Applicable

Completed

• Conditions: Ametropia
• Interventions: Device: Phenacite; Device: comfilcon A

• Registration Number: NCT02436005
• Lead Sponsor: Coopervision, Inc.

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-05-01
• Study First Submitted QC: 2015-05-01
• Study First Posted: 2015-05-06
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2020-10
• Results First Submitted: 2020-10-09
• Results First Submitted QC: 2020-10-09
• Last Update Submitted: 2020-10-30
• Results First Posted: 2020-11-02
• Last Update Posted: 2020-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Phenacite	Phenacite	Subjects will be randomized to wear the Phenacite contact lenses binocularly.
Phenacite	comfilcon A	Subjects will be randomized to wear the Phenacite contact lenses binocularly.
comfilcon A	Phenacite	Subjects will be randomized to wear the comfilcon A contact lenses binocularly.
comfilcon A	comfilcon A	Subjects will be randomized to wear the comfilcon A contact lenses binocularly.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University; 🇺🇸 Bloomington, Indiana, United States