Clinical Validation Study of Comfilcon A Multifocal Toric Contact Lenses

Not Applicable

Completed

• Conditions: Presbyopia
• Interventions: Device: Comfilcon A lens (test); Device: Omafilcon B lens (control)

• Registration Number: NCT03417557
• Lead Sponsor: Coopervision, Inc.

Brief Summary

This is a study to evaluate the clinical performance and subjective acceptance of an investigational contact lens (test), compared to a marketed lens (control) in an in-office setting.

Detailed Description

This is a study to evaluate the clinical performance (including visual acuity, subjective assessments of visual performance, comfort ratings, vision preference and lens fit) of a comfilcon A investigational contact lens (test) compared to a control contact lens, in a non-dispensing setting. The main study hypothesis is the test contact lens will not be clinically inferior to the control lens.

Study Timeline

• Study Start: 2018-01-12
• Study First Submitted: 2018-01-25
• Study First Submitted QC: 2018-01-25
• Study First Posted: 2018-01-31
• Primary Completion: 2018-04-03
• Study Completion: 2018-04-03
• Disposition First Submitted: 2019-12-19
• Results First Submitted: 2020-01-14
• Status Verified: 2020-04
• Results First Submitted QC: 2020-04-30
• Disposition First Submitted QC: 2020-04-30
• Last Update Submitted: 2020-04-30
• Results First Posted: 2020-05-04
• Disposition First Posted: 2020-05-04
• Last Update Posted: 2020-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Has had a self-reported oculo-visual examination in the last two years.
• Is between ages 40-75 years, inclusive and has full legal capacity to volunteer.
• Has read and understood the information consent letter. Is willing and able to follow instructions and maintain the appointment schedule.
• Is able to participate in Parts A and B related to this work.
• Has a contact lens spherical prescription between +10.00 to 10.00D (inclusive).
• Has an Add component to their spectacle refraction (between +0.75 and +2.50DS).
• Has astigmatism between of -0.75 and -5.75DC (based on the calculated ocular refraction) in each eye.
• Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/25 best-corrected.
• Currently wears soft contact lenses.
• Has clear corneas and no active ocular disease.
• Has not worn lenses for at least 12 hours before the examination.

Exclusion Criteria

A person will be excluded from the study if he/she:

• 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 undergone corneal refractive surgery.
• Is participating in any other type of eye related clinical or research study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Comfilcon A lens (test)	Comfilcon A lens (test)	Subjects are randomized to wear comfilcon A lens for up to 3 hours, either as first or second lens during this cross over study.
Omafilcon B Lens (control)	Omafilcon B lens (control)	Subjects are randomized to wear omafilcon B lens for up to 3 hours, either as first or second lens during this cross over study.

Primary Outcome Measures

Name	Time	Method
Visual Acuity	up to 3 hours	Visual acuity is assessed for test and control lens on a logMAR chart

Secondary Outcome Measures

Name	Time	Method
Subjective Assessment of Visual Performance: Distance Day-time Navigation Tasks for Vision Quality and Clarity	up to 3 hours	Subjective assessment of visual performance for distance day-time navigation tasks for vision/clarity was assessed for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent.
Subjective Assessment of Visual Performance: Intermediate / Computer Task for Vision Quality and Clarity	up to 3 hours	Subjective assessments of visual performance for intermediate / computer tasks for vision quality and clarity were assessed for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent.
Subjective Assessment of Visual Performance: Near Vision for Vision Quality and Clarity	up to 3 hours	Subjective assessments of visual performance for near vision was assessed for vision quality and clarity for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent.

Trial Locations

Locations (1)

Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University; 🇺🇸 Bloomington, Indiana, United States