Clinical Evaluation of Invigor Toric 1-Day Contact Lenses

NCT ID: NCT04016623

Last Updated: 2020-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-06
• Study Completion Date: 2019-06-04

Brief Summary

An evaluation of the clinical performance of the 1-day toric test contact lens compared to the 1-day toric control contact lens over one hour of lens wear.

Detailed Description

A non-dispensing, double-masked, randomized, contralateral study comparing the 1-day toric test contact lens against the 1-day toric control contact lens to evaluate the clinical performance over one hour of lens wear. Each subject will be randomized to wear the test lens in one eye and the control lens in the other eye for each pair of lenses.

Each subject will be asked to wear four pairs of contact lenses in the study

Conditions

Astigmatism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1-day toric test contact lens

Each subject will wear the 1-day toric test (Test) lens in one eye and 1-day toric control (Control) contact lens in the other eye. Patient will wear as an unmatched pair, per predetermined randomization schedule (to determine which eye receives the Test or Control contact lens).

Group Type: EXPERIMENTAL

1-day toric test contact lens

Intervention Type: DEVICE

somofilcon A 1-day toric test contact lens

1-day toric control contact lens

Intervention Type: DEVICE

somofilcon A 1-day toric control contact lens

1-day toric control contact lens

Each subject will wear the 1-day toric test (Test) lens in one eye and 1-day toric control (Control) contact lens in the other eye. Patient will wear as an unmatched pair, per predetermined randomization schedule (to determine which eye receives the Test or Control contact lens).

Group Type: ACTIVE_COMPARATOR

1-day toric test contact lens

Intervention Type: DEVICE

somofilcon A 1-day toric test contact lens

1-day toric control contact lens

Intervention Type: DEVICE

somofilcon A 1-day toric control contact lens

Interventions

1-day toric test contact lens

somofilcon A 1-day toric test contact lens

Intervention Type: DEVICE

1-day toric control contact lens

somofilcon A 1-day toric control contact lens

Intervention Type: DEVICE

Other Intervention Names

Test contact lens; Invigor toric 1-day contact lens; Control contact lens

Eligibility Criteria

Inclusion Criteria

• Has had a self-reported oculo-visual examination in the last two years.
• Is at least 18 years of age 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 correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CooperVision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pete S Kollbaum, OD PhD

Role: PRINCIPAL_INVESTIGATOR

Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University

Locations

Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University

Bloomington, Indiana, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CV-19-27

Identifier Type: -

Identifier Source: org_study_id