Pilot Clinical Performance of a Silicone Hydrogel Lens for Up to Six Nights of Extended Wear

NCT ID: NCT04403542

Last Updated: 2023-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-03
• Study Completion Date: 2020-08-31

Brief Summary

The purpose of this clinical study is to evaluate the on-eye performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn continuously for up to 1 week.

Detailed Description

Subjects will be randomized to wear the investigational contact lens in 1 eye and the commercially available contact lens in the other eye. Subjects will be expected to attend 3 scheduled study visits: Day 1 Screening/Baseline/Dispense; Day 2 Follow-up within 4 hours of awakening (after the first night of sleeping); and Week 1 Follow-up/Exit. The expected duration of exposure to each of the study lenses for all randomized, completed subjects was approximately 7 days / 6 nights of wear.

Conditions

Refractive Errors; Myopia; Hyperopia

Study Design

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

Study Groups

LID018869 (OD) / Biofinity (OS)

Lehfilcon A contact lens worn in the right eye, with comfilcon A contact lens worn in the left eye, as randomized, for approximately 1 week of continuous wear

Group Type: EXPERIMENTAL

Lehfilcon A contact lens

Intervention Type: DEVICE

Investigational silicone hydrogel contact lens

Comfilcon A contact lens

Intervention Type: DEVICE

Commercially available silicone hydrogel contact lens

Biofinity (OD) / LID018869 (OS)

Comfilcon A contact lens worn in the right eye, with lehfilcon A contact lens worn in the left eye, as randomized, for approximately 1 week of continuous wear

Group Type: ACTIVE_COMPARATOR

Lehfilcon A contact lens

Intervention Type: DEVICE

Investigational silicone hydrogel contact lens

Comfilcon A contact lens

Intervention Type: DEVICE

Commercially available silicone hydrogel contact lens

Interventions

Lehfilcon A contact lens

Investigational silicone hydrogel contact lens

Intervention Type: DEVICE

Comfilcon A contact lens

Commercially available silicone hydrogel contact lens

Intervention Type: DEVICE

Other Intervention Names

LID018869; Biofinity

Eligibility Criteria

Inclusion Criteria

• Able to understand and sign an IRB/IEC approved Informed Consent form.
• Successful wear of spherical soft contact lenses in both eyes during the past 3 months for a minimum of 5 days/week and in an extended wear modality at least 1 night/week.
• Best corrected visual acuity of 20/25 or better in each eye.

Exclusion Criteria

• Any condition, use of medications, or surgery that could contraindicate contact lens wear, as determined by the Investigator.
• Any habitual wear of Biofinity contact lenses.
• Pregnant or breast-feeding.

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

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

CDMA Project Lead, Vision Care

Role: STUDY_DIRECTOR

Alcon Research, LLC

Locations

Alcon Investigator 6402

Medina, Minnesota, United States

Alcon Investigator 8046

Granville, Ohio, United States

Alcon Investigator 2786

Memphis, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CLY935-C008

Identifier Type: -

Identifier Source: org_study_id