Dispensing Study for the Phenacite Project

NCT02436005 | Completed Results FDA Device

• 1 other identifier: CV-15-16
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Ametropia

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (18)

• Lens Fit - Post Blink Movement

  Baseline (after 15 minutes of lens dispense)

• Lens Fit - Post Blink Movement

  2 weeks

• Push - Up Test for Lens Tightness

  Baseline (after 15 minutes of lens dispense)

• Push - Up Test for Lens Tightness

  2 weeks

• Lens Mobility Rating

  Baseline (after 15 minutes of lens dispense)

Study Arms (2)

Phenacite

EXPERIMENTAL

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

Device: Phenacite; Device: comfilcon A

comfilcon A

ACTIVE COMPARATOR

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

Device: Phenacite; Device: comfilcon A

Interventions

Phenacite DEVICE

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

Phenacite; comfilcon A

comfilcon A DEVICE

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

Phenacite; comfilcon A

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

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

Bloomington, Indiana, 47405, United States

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Paul Chamberlain
• Organization: CooperVision Inc.

PChamberlain@coopervision.com

925 730-6754

Study Officials

• Pete Kollbaun, OD PhD

  CORL Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2015
• First Posted: May 6, 2015
• Study Start: April 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: November 18, 2020
• Results First Posted: November 2, 2020

Record last verified: 2020-10

Locations

US (1)