Clinical Performance of a Silicone Hydrogel Contact Lens Following One Night of Extended Wear

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

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-11

Study Completion Date

2018-07-17

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 evaluate the on-eye performance of an investigational soft contact lens compared to a commercially available soft contact lens following 1 night of extended wear.

Related Clinical Trials

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

Clinical Performance of a Silicone Hydrogel Contact Lens Following Six Nights of Extended Wear

NCT03614130

Refractive Errors

COMPLETED NA

Clinical Performance of a Monthly Replacement Silicone Hydrogel Lens

NCT03586167

Refractive Errors

COMPLETED NA

Clinical Performance Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens

NCT04055519

Refractive Errors

COMPLETED NA

Clinical Assessment of a Daily Wear Monthly Replacement Silicone Hydrogel Toric Contact Lens

NCT05211739

Refractive Errors Astigmatism

COMPLETED NA

Clinical Evaluation of a Daily Wear Silicone Hydrogel Lens

NCT04207749

Refractive Errors Myopia Hyperopia

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 the investigational contact lens in 1 eye and the commercially available contact lens in the other eye. Subjects will be expected to attend 4 scheduled study visits. The lenses will be worn continuously from the time of dispense on Day 1 until lens collection at the Day 2 Follow-up/Exit Visit.

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

SINGLE_GROUP

In this contralateral study, subjects will be randomized to wear the investigational lens in 1 eye and the control lens in the other eye.

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.

LID011121 (OD) / Biofinity (OS)

LID011121 contact lens worn in the right eye, with comfilcon A contact lens worn in the left eye, as randomized, for one night of extended (overnight) wear.

Group Type OTHER

LID011121 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) / LID011121 (OS)

Comfilcon A contact lens worn in the right eye, with LID011121 contact lens worn in the left eye, as randomized, for one night of extended (overnight) wear.

Group Type OTHER

LID011121 contact lens

Intervention Type DEVICE

Investigational silicone hydrogel contact lens

Comfilcon A contact lens

Intervention Type DEVICE

Commercially available silicone hydrogel contact lens

Interventions

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

LID011121 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

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

* Able to understand and sign an 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 per week in either a daily wear or extended wear modality.
* Best Corrected Visual Acuity (BCVA) 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.
* Current Biofinity® lens wearer.
* Pregnant or breast-feeding.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No