Clinical Validation Study of Comfilcon A Multifocal Toric Contact Lenses

Presbyopia Clinical Trial

Official title:

Clinical Validation Study of Biofinity Multifocal Toric Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03417557
• Other study ID #: CV-18-10
• Status: Completed
• Phase: N/A
• Start date: January 12, 2018
• Est. completion date: April 3, 2018

Study information

• Verified date: April 2020
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 3, 2018
• Est. primary completion date: April 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Presbyopia

Intervention

Device:
• Comfilcon A lens (test)
contact lens
• Omafilcon B lens (control)
contact lens

Locations

Country	Name	City	State
United States	Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University	Bloomington	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity	Visual acuity is assessed for test and control lens on a logMAR chart	up to 3 hours
Secondary	Subjective Assessment of Visual Performance: Distance Day-time Navigation Tasks for Vision Quality and Clarity	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.	up to 3 hours
Secondary	Subjective Assessment of Visual Performance: Intermediate / Computer Task for Vision Quality and Clarity	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.	up to 3 hours
Secondary	Subjective Assessment of Visual Performance: Near Vision for Vision Quality and Clarity	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.	up to 3 hours