One Week Assessment of The Phenacite Lens

NCT02553395 | Completed Results

• 1 other identifier: CV-15-40
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate performance criteria over one week of daily wear to determine if the Study Test contact lens performs equivalently to the comfilcon A contact lenses in terms of subjective ratings and of visual performance. The study test lens was not the final optical design and the study results were not used for the design validation.

Conditions

Myopia

Outcome Measures

Primary Outcomes (11)

• Binocular Distance Visual Acuity (VA) - High Illumination High Contrast

  Binocular Distance visual acuity High Illumination High Contrast was assessed using logMAR (0.02 logMAR= 1 letter)

  Baseline - After 5 minutes of lens settling

• Binocular Distance Visual Acuity (VA) -High Illumination High Contrast

  Binocular Distance visual acuity High Illumination High Contrast was assessed using logMAR (0.02 logMAR= 1 letter)

  1 week

• Binocular Near Visual Acuity (VA) - High Illumination High Contrast

  Binocular Near Visual Acuity High Illumination High Contrast was assessed on logMAR VA (0.02 logMAR= 1 letter)

  Baseline - after 5 minutes of lens dispense

• Binocular Near Visual Acuity (VA) - High Illumination High Contrast

  Binocular Near Visual Acuity High Illumination High Contrast was assessed on logMAR VA (0.02 logMAR= 1 letter)

  1-week

• Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast

  Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter)

  Baseline (After 5 minutes of lens settling)

• Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast

  Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter)

  1 week

• Binocular Near Visual Acuity (VA) - Low Illumination High Contrast

  Binocular Near Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter)

  Baseline (after 5 minutes of lens settling)

• Binocular Near Visual Acuity (VA) - Low Illumination High Contrast

  Binocular Near Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter)

  1week

• Subjective Ratings for Distance Quality of Vision

  Patient subjective scoring using anchors on the scale to provide a score between 0-100 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)

  1 week

• Subjective Ratings for Intermediate Quality of Vision

  Patient subjective scoring using anchors on the scale to provide a score between 0-100 for Intermediate 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)

  1 week

• Subjective Ratings for Near Quality of Vision

  Patient subjective scoring using anchors on the scale to provide a score between 0-100 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)

  1 week

Secondary Outcomes (12)

• Post Blink Movement -

  Baseline (After 5 minutes of lens dispense)

• Post Blink Movement

  1 week

• Push - Up Test for Lens Tightness

  Baseline (After 5 minutes of lens dispense)

• Push - Up Test for Lens Tightness

  1 week

• Lens Mobility Rating

  Baseline (after 5 minutes of lens dispense)

Study Arms (2)

Phenacite contact lens

EXPERIMENTAL

Study Test Contact Lens

Device: Phenacite (Test) contact lens

comfilcon A contact lens

ACTIVE COMPARATOR

Control Contact Lens

Device: comfilcon A contact lens

Interventions

Phenacite (Test) contact lens DEVICE

Phenacite contact lens

comfilcon A contact lens DEVICE

comfilcon A contact lens

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 (Diopter) and -4.50D
• Spherical Contact Lens Rx between -1.00 and -4.00 and spectacle cylinder \<-0.75
• 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:

• A person will be excluded from the study if he/she:
• Has never worn contact lenses before.
• Has any systemic disease affecting ocular health.
• Is using any systemic or topical medications that will affect ocular health.
• Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
• Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
• Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
• Is aphakic.
• Has undergone corneal refractive surgery.
• Is participating in any other type of eye related clinical or research study.

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

Myopia

Interventions

Contact Lenses

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Results Point of Contact

• Title: Paul Chamberlain
• Organization: CooperVision Inc.

PChamberlain@coopervision.com

925 730-6754

Study Officials

• Peter Kollbaum, OD, PhD

  Clinical Optics Research Lab (CORL)

  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: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2015
• First Posted: September 17, 2015
• Study Start: September 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: October 1, 2015
• Last Updated: December 22, 2020
• Results First Posted: December 22, 2020

Record last verified: 2020-11

Locations

US (1)