A One-Week Crossover Dispensing Evaluation of New Daily Wear Soft Contact Lenses

NCT03306641 | Completed Results FDA Device

• 1 other identifier: CV-17-29
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period 1 week compared to nelfilcon A (control).

Conditions

Myopia

Outcome Measures

Primary Outcomes (2)

• Lens Fit Acceptance

  Overall lens fit acceptance was measured on a scale of 0-4 in 0.25 steps (0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)

  Baseline

• Lens Fit Acceptance

  Overall lens fit acceptance was measured on a scale of 0-4 in 0.25 steps (0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)

  1-Week

Study Arms (2)

Test Contact Lens

ACTIVE COMPARATOR

Per randomized schedule, subject will wear a pair of the test lens or control lens for one week and then cross-over with the control pair for 1 week.

Device: Test Contact Lens; Device: Nelfilcon A

nelfilcon A lens (control)

ACTIVE COMPARATOR

Per randomized schedule, subject will wear a pair of the control lens for one week and then cross-over with the test pair for 1 week.

Device: Test Contact Lens; Device: Nelfilcon A

Interventions

Test Contact Lens DEVICE

Daily disposable contact lens

Test Contact Lens; nelfilcon A lens (control)

Nelfilcon A DEVICE

Focus Dailies All Day Comfort contact lens (nelfilcon A)

Test Contact Lens; nelfilcon A lens (control)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Is at least 18 years of age and has full legal capacity to volunteer.
• Is no greater than 55 years of age.
• Has read and understood the information consent letter.
• Is willing and able to follow instructions and maintain the appointment schedule.
• Is an adapted soft contact lens wearer having worn lenses for a minimum of 4 weeks prior to the study.
• Has spectacle cylinder ≤1.00D in both eyes.
• Has spherical contact lens power requirement between -1.00D and -6.00D in both eyes.
• Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye.
• Wears CLs in both eyes (monvision acceptable, but not monofit)
• Has clear corneas and no active ocular disease.
• Has not worn lenses for at least 12 hours before the examination.
• Is willing to wear the study contact lenses for a minimum 8 hours per day/6 days per week

You may not qualify if:

• 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 strabismus/amblyopia.
• Has undergone corneal refractive surgery.
• Is pregnant, lactating or planning a pregnancy.
• Is participating in any concurrent 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

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Lee Hall, BSc, PhD, MCOptom, FBCLA
• Organization: CooperVision, Inc

lhall@coopervision.com

925 251 6684

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
• Masking Details: The contact lenses coding will be masked to both the investigator and subject. If standard labeling does not sufficiently mask the study material then over-labeling will be performed.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This will be a double-masked, bilateral, 1-week crossover, dispensing study, comparing the test daily wear lens against nelfilcon A control lens, such that each lens type will be worn for 1 week each. Each subject will be randomized to wear either the test lenses or the control lenses as a matched pair.

Study Record Dates

• First Submitted: August 15, 2017
• First Posted: October 11, 2017
• Study Start: July 28, 2017
• Primary Completion: August 31, 2017
• Study Completion: August 31, 2017
• Last Updated: September 22, 2020
• Results First Posted: September 22, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)