Clinical Evaluation of a Daily Wear Frequent Replacement Silicone Hydrogel Lens

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-22

Study Completion Date

2019-10-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this clinical study is to demonstrate the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in a daily wear modality.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Evaluation of a Daily Wear Monthly Replacement Silicone Hydrogel Lens

NCT04178720

Refractive Errors

COMPLETED NA

Clinical Evaluation of a Daily Wear Silicone Hydrogel Lens

NCT04207749

Refractive Errors Myopia Hyperopia

COMPLETED NA

Clinical Evaluation of a Silicone Hydrogel Daily Wear Monthly Replacement Contact Lens

NCT04422990

Refractive Errors

COMPLETED NA

Assessment of an Investigational Frequent Replacement Silicone Hydrogel Lens

NCT04085328

Refractive Ametropia

COMPLETED NA

Clinical Performance of a Monthly Replacement Silicone Hydrogel Lens

NCT03586167

Refractive Errors

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Subjects will be randomized to wear either the investigational contact lenses or the commercially available contact lenses in both eyes. Subjects will be expected to attend 6 scheduled study visits. Individual participation in the study will be approximately 3 months.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Refractive Errors

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LID015385

LID015385 contact lenses worn in both eyes during waking hours only for at least 8 hours per day and 5 days per week over a 3-month exposure period. Lenses will be removed nightly for cleaning with CLEAR CARE.

Group Type EXPERIMENTAL

LID015385 contact lenses

Intervention Type DEVICE

Investigational silicone hydrogel contact lenses

CLEAR CARE

Intervention Type DEVICE

Hydrogen peroxide-based cleaning and disinfecting system

Biofinity

Comfilcon A contact lenses worn in both eyes during waking hours only for at least 8 hours per day and 5 days per week over a 3-month exposure period. Lenses will be removed nightly for cleaning with CLEAR CARE.

Group Type ACTIVE_COMPARATOR

Comfilcon A soft contact lenses

Intervention Type DEVICE

Commercially available silicone hydrogel contact lenses

CLEAR CARE

Intervention Type DEVICE

Hydrogen peroxide-based cleaning and disinfecting system

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LID015385 contact lenses

Investigational silicone hydrogel contact lenses

Intervention Type DEVICE

Comfilcon A soft contact lenses

Commercially available silicone hydrogel contact lenses

Intervention Type DEVICE

CLEAR CARE

Hydrogen peroxide-based cleaning and disinfecting system

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Biofinity

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Successful wear of spherical daily wear frequent replacement soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day.
* Manifest cylinder ≤ 0.75 diopter (D) in each eye.

Exclusion Criteria

* Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
* Monovision contact lens wearers.
* Habitually wearing Biofinity® lenses.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No