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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03496701
• Other study ID #: EX-MKTG-86
• Status: Completed
• Phase: N/A
• Start date: April 18, 2018
• Est. completion date: January 17, 2019

Study information

• Verified date: June 2021
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: January 17, 2019
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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)

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Test lens
contact lens
• control lens
contact lens

Locations

Country	Name	City	State
United States	Eric White, O.D., Inc.	San Diego	California
United States	Golden Vision	Sarasota	Florida
United States	Nittany Eye Associates	State College	Pennsylvania
United States	Golden Optometric Group	Whittier	California

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Lens Centration	Lens centration was assessed on a 3 point scale (1-Optimum, 2- Decentration acceptable, 3-Decentration unacceptable)	Baseline - After 10 minutes of lens dispense
Secondary	Lens Centration	Lens centration was assessed on a 3 point scale (1-Optimum, 2- Decentration acceptable, 3-Decentration unacceptable)	1 week on each study lenses
Secondary	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)	Baseline (after 10 minutes of lens dispense)
Secondary	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)	1 week on each study lenses