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

NCT ID: NCT03496701

Last Updated: 2021-06-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-18
• Study Completion Date: 2019-01-17

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.

Detailed Description

This study is a prospective, multi-center, open label, bilateral, daily wear, one week dispensing study comparing performance of wearers of stenfilcon A control contact lenses after refit with test contact lenses.

Conditions

Myopia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stenfilcon A / Test lens

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

Group Type: EXPERIMENTAL

Test lens

Intervention Type: DEVICE

contact lens

control lens

Intervention Type: DEVICE

contact lens

Interventions

Test lens

contact lens

Intervention Type: DEVICE

control lens

contact lens

Intervention Type: DEVICE

Other Intervention Names

stenfilcon A Test lens; stenfilcon A Control lens

Eligibility Criteria

Inclusion Criteria

A person is eligible for inclusion in the study if he/she:

• 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.

Exclusion Criteria

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)
• Has a known sensitivity to the diagnostic pharmaceuticals to be used in the study
• Has aphakia, keratoconus or a highly irregular cornea.
• Has presbyopia or has dependence on spectacles for near work over the contact lenses.
• Has undergone refractive surgery.
• Is pregnant, lactating or planning a pregnancy (by verbal communication) at the time of enrollment
• Has participated in any other type of eye related clinical or research study within the last 7 days
• Is habitually using rewetting/ lubricating eye drops (more than once per day)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CooperVision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Ardaya

Role: PRINCIPAL_INVESTIGATOR

Golden Optometric Group, CA

Shane Kannarr

Role: PRINCIPAL_INVESTIGATOR

Kannarr Eye Care, KS

Michael Cymbor

Role: PRINCIPAL_INVESTIGATOR

Nittany Eye Associates, PA

Wayne Golden

Role: PRINCIPAL_INVESTIGATOR

Golden Vision, FL

Eric M. White

Role: PRINCIPAL_INVESTIGATOR

CA

Locations

Eric White, O.D., Inc.

San Diego, California, United States

Golden Optometric Group

Whittier, California, United States

Golden Vision

Sarasota, Florida, United States

Nittany Eye Associates

State College, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

EX-MKTG-86

Identifier Type: -

Identifier Source: org_study_id