Clinical Evaluation of Investigational Multifocal Toric Contact Lenses

NCT03519282 | Completed Results FDA Device

• 1 other identifier: CV-18-11
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

This non-dispensing study is to evaluate the clinical performance of a test multifocal toric silicone hydrogel contact lens compared to a marketed multifocal toric contact lens (control).

Conditions

Presbyopia; Astigmatism

Outcome Measures

Primary Outcomes (1)

• Visual Acuity

  Visual Acuity (measured in LogMAR)

  Up to 2 hours

Secondary Outcomes (3)

• Assessment of Visual Performance: Distance Navigation Tasks for Vision Quality and Clarity

  Up to 2 hours

• Assessment of Visual Performance: Intermediate Task for Vision Quality and Clarity

  Up to 2 hours

• Assessment of Visual Performance: Near Task for Vision Quality and Clarity

  Up to 2 hours

Study Arms (2)

Test Multifocal Toric Lens

EXPERIMENTAL

comfilcon A multifocal toric lens

Device: comfilcon A multifocal toric lens; Device: omafilcon A Multifocal Toric Lens

omafilcon A Multifocal Toric Lens

ACTIVE COMPARATOR

Control multifocal toric lens

Device: comfilcon A multifocal toric lens; Device: omafilcon A Multifocal Toric Lens

Interventions

comfilcon A multifocal toric lens DEVICE

contact lens

Also known as: Test Multifocal Toric Lens, Biofinity multifocal toric lens

Test Multifocal Toric Lens; omafilcon A Multifocal Toric Lens

omafilcon A Multifocal Toric Lens DEVICE

contact lens

Also known as: Proclear multifocal toric lens, Control multifocal toric lens

Test Multifocal Toric Lens; omafilcon A Multifocal Toric Lens

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has had a self-reported oculo-visual examination in the last two years.
• Is aged 40-75 years, inclusive and has full legal capacity to volunteer.
• Has read and understood the participant information sheet.
• 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 -0.75 and -5.75DC (based on the vertexed ocular refraction in each eye.
• Can be satisfactorily fitted with the study lenses.
• Is correctable to a visual acuity of 20/40 (0.30 logMAR) or better (in each eye) with their habitual vision correction or 20/25 (0.10 logMAR) best-corrected.
• They have successfully worn soft contact lenses in the last six months
• Has clear corneas and no active ocular disease.
• Has not worn lenses for at least 12 hours before the examination.
• Has an up-to-date pair of spectacles.

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, in the opinion of the investigator, affect the wearing of contact lenses.
• Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye that would, in the opinion of the investigator, be problematic for their participation in the study.
• Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
• Is aphakic.
• Has undergone corneal refractive surgery.
• Has a history of anaphylaxis or severe allergic reaction.
• Has diabetes or an infectious or immunosuppressive disease which could contraindicate contact lens wear or pose a risk to the investigator.
• They are pregnant or breast-feeding.
• Is participating in any other type of eye-related clinical or research study.

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

Eurolens Research

Manchester, M13 9PL, United Kingdom

Location

MeSH Terms

Conditions

Presbyopia; Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Myhanh Nguyen, Sr. Optometrist
• Organization: CooperVision

MNguyen@coopervision.com

925-730-6716

Study Officials

• Philip Morgan, BSc, PhD, MCOptom

  Eurolens Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: May 8, 2018
• Study Start: April 25, 2018
• Primary Completion: July 24, 2018
• Study Completion: July 24, 2018
• Last Updated: May 4, 2020
• Results First Posted: May 4, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)