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

Primary Purpose

Myopia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Test lens

control lens

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Eric White, O.D., Inc.
Golden Optometric Group
Golden Vision
Nittany Eye Associates

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stenfilcon A / Test lens

Arm Description

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

Outcomes

Primary Outcome Measures

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)

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)

Secondary Outcome Measures

Lens Centration

Lens centration was assessed on a 3 point scale (1-Optimum, 2- Decentration acceptable, 3-Decentration unacceptable)

Lens Centration

Lens centration was assessed on a 3 point scale (1-Optimum, 2- Decentration acceptable, 3-Decentration unacceptable)

Post-blink Movement

Post-blink movement assessed on a scale of 0-4, 1 step size (Scale: 0=Insufficient, 1=Minimal, 2=Optimal, 3=Moderate, 4=Excessive)

Post-blink Movement

Post-blink movement assessed on a scale of 0-4, 1 step size (Scale: 0=Insufficient, 1=Minimal, 2=Optimal, 3=Moderate, 4=Excessive)

Full Information

NCT ID

NCT03496701

First Posted

April 5, 2018

Last Updated

June 28, 2021

Sponsor

Coopervision, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03496701

Brief Title

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

Official Title

Performance of Wearers of MyDay Sphere Lenses After A Refit With MyDay Energys Lenses for One Week

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

April 18, 2018 (Actual)

Primary Completion Date

June 1, 2018 (Actual)

Study Completion Date

January 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Coopervision, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myopia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

77 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Stenfilcon A / Test lens

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Test lens

Other Intervention Name(s)

stenfilcon A Test lens

Intervention Description

contact lens

Intervention Type

Device

Intervention Name(s)

control lens

Other Intervention Name(s)

stenfilcon A Control lens

Intervention Description

contact lens

Primary Outcome Measure Information:

Title

Overall Lens Fit Acceptance

Description

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

Time Frame

Baseline (After 10 minutes of lens dispense)

Title

Overall Lens Fit Acceptance

Description

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

Time Frame

1 week on each study lenses

Secondary Outcome Measure Information:

Title

Lens Centration

Description

Lens centration was assessed on a 3 point scale (1-Optimum, 2- Decentration acceptable, 3-Decentration unacceptable)

Time Frame

Baseline - After 10 minutes of lens dispense

Title

Lens Centration

Description

Lens centration was assessed on a 3 point scale (1-Optimum, 2- Decentration acceptable, 3-Decentration unacceptable)

Time Frame

1 week on each study lenses

Title

Post-blink Movement

Description

Post-blink movement assessed on a scale of 0-4, 1 step size (Scale: 0=Insufficient, 1=Minimal, 2=Optimal, 3=Moderate, 4=Excessive)

Time Frame

Baseline (after 10 minutes of lens dispense)

Title

Post-blink Movement

Description

Post-blink movement assessed on a scale of 0-4, 1 step size (Scale: 0=Insufficient, 1=Minimal, 2=Optimal, 3=Moderate, 4=Excessive)

Time Frame

1 week on each study lenses

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

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)

Overall Study Officials: