Performance of Wearers of Stenfilcon A Contact Lenses After A Refit With Test Lenses

NCT03496701 | Completed Results FDA Device

• 1 other identifier: EX-MKTG-86
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 4

Brief Summary

The aim of this study is to determine if habitual or adapted wearers of stenfilcon A control contact lenses can be refit into test lenses and be successful after one week of daily wear.

Conditions

Myopia

Outcome Measures

Primary Outcomes (2)

• Overall Lens Fit Acceptance

  Overall lens fit acceptance on a scale of 0-4, 0.5 steps (Scale: 0=should not be worn, 4=perfect)

  Baseline (After 10 minutes of lens dispense)

• Overall Lens Fit Acceptance

  Overall lens fit acceptance on a scale of 0-4, 0.5 steps (Scale: 0=should not be worn, 4=perfect)

  1 week on each study lenses

Secondary Outcomes (4)

• Lens Centration

  Baseline - After 10 minutes of lens dispense

• Lens Centration

  1 week on each study lenses

• Post-blink Movement

  Baseline (after 10 minutes of lens dispense)

• Post-blink Movement

  1 week on each study lenses

Study Arms (1)

Stenfilcon A / Test lens

EXPERIMENTAL

All subjects will first wear stenfilcon A contact lenses for one week, then refitted with test contact lenses to wear for one week.

Device: Test lens; Device: control lens

Interventions

Test lens DEVICE

contact lens

Also known as: stenfilcon A Test lens

Stenfilcon A / Test lens

control lens DEVICE

contact lens

Also known as: stenfilcon A Control lens

Stenfilcon A / Test lens

Eligibility Criteria

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

You may qualify if:

• Is between 18 and 35 years of age (inclusive)
• Has read and signed the informed consent letter
• Is willing and anticipated to follow instructions and maintain the appointment schedule
• Habitually wears soft spherical contact lenses with a power between -1.00D to -6.00D (inclusive) for a minimum 5 days per week, 10 hours per day and anticipates no difficulty wearing contact lenses for 7 days per week, 10 hours per day.
• Habitually wears or is able to be adequately refit into MyDay Sphere lenses
• Demonstrates an acceptable fit with the study lenses
• Is correctable to a distance visual acuity of 0.20 logMAR (approximately 20/30) or better (in each eye) with the study contact lenses
• Uses digital devices, (e.g. computer, tablet, smart phone, iPad), for more than 4 hours a day, 5 days a week.
• Manifest cylindrical spectacle refraction does not exceed -0.75DC in either eye
• Has clear corneas and no active ocular disease
• Has a contact lens refraction that fits within the available parameters of the study lenses.

You may not qualify if:

• A person will be excluded from the study if he/she:
• Is participating in any concurrent clinical research study
• Has a history of not achieving comfortable CL wear (5 days per week; \> 8 hours/day)
• Has a systemic condition that, in the opinion of the investigator, may affect the study measures
• Is using any systemic or topical medications that in the opinion of the investigator may affect the study measures.
• Presents with slit lamp findings or clinically significant anterior segment abnormalities that would contraindicate contact lens wear such as:
• Pathological dry eye or associated findings
• Significant pterygium, pinguecula, or corneal scars within the visual axis
• Neovascularization \> 0.75 mm in from of the limbus
• Giant papillary conjunctivitis (GCP) worse than grade 1
• Anterior uveitis or iritis (or history in past year)
• Seborrheic eczema of eyelid region, Seborrheic conjunctivitis
• History of corneal ulcers or fungal infections
• Poor personal hygiene
• Has a known history of corneal hypoesthesia (reduced corneal sensitivity)

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (4)

Eric White, O.D., Inc.

San Diego, California, 92123, United States

Location

Golden Optometric Group

Whittier, California, 90606, United States

Location

Golden Vision

Sarasota, Florida, 34232, United States

Location

Nittany Eye Associates

State College, Pennsylvania, 16801, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Jose A. Vega
• Organization: CooperVision, Inc

javega2@coopervision.com

925-640-2964

Study Officials

• David Ardaya

  Golden Optometric Group, CA

  PRINCIPAL INVESTIGATOR

• Shane Kannarr

  Kannarr Eye Care, KS

  PRINCIPAL INVESTIGATOR

• Michael Cymbor

  Nittany Eye Associates, PA

  PRINCIPAL INVESTIGATOR

• Wayne Golden

  Golden Vision, FL

  PRINCIPAL INVESTIGATOR

• Eric M. White

  CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: April 12, 2018
• Study Start: April 18, 2018
• Primary Completion: June 1, 2018
• Study Completion: January 17, 2019
• Last Updated: June 30, 2021
• Results First Posted: June 29, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)