Clinical Characterization of an Investigational Frequent Replacement Daily Wear Silicone Hydrogel Sphere Contact 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

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-21

Study Completion Date

2021-02-26

Brief Summary

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

The primary objective of this study is to evaluate the overall clinical performance of an investigational silicone hydrogel contact lens over 7 days of daily wear.

Related Clinical Trials

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

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

NCT04476784

Myopia

COMPLETED NA

Clinical Performance of Two Reusable Silicone Hydrogel Contact Lenses

NCT05431478

Refractive Errors

COMPLETED NA

Clinical Evaluation of a Daily Wear Frequent Replacement Silicone Hydrogel Lens

NCT03920280

Refractive Errors

COMPLETED NA

Clinical Evaluation of a Daily Wear Silicone Hydrogel Lens

NCT04207749

Refractive Errors Myopia Hyperopia

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.

Participants will attend a Screening visit, a Dispense visit, and a Week 1 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

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Lens will be provided with investigational product labeling

Study Groups

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

LID021201

LID021201 contact lenses worn in both eyes for 7 days. Lenses will be removed nightly for cleaning and disinfection with OPTI-FREE multipurpose solution.

Group Type EXPERIMENTAL

LID021201 contact lenses

Intervention Type DEVICE

Investigational silicone hydrogel sphere contact lenses for frequent replacement daily wear

OPTI-FREE multipurpose solution

Intervention Type DEVICE

Solution for cleaning, disinfecting, and reconditioning silicone hydrogel contact lenses

Interventions

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

LID021201 contact lenses

Investigational silicone hydrogel sphere contact lenses for frequent replacement daily wear

Intervention Type DEVICE

OPTI-FREE multipurpose solution

Solution for cleaning, disinfecting, and reconditioning silicone hydrogel contact lenses

Intervention Type DEVICE

Other Intervention Names

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

OPTI-FREE® RepleniSH®

Eligibility Criteria

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

Inclusion Criteria

* Understand and sign an Informed Consent that has been approved by an Institutional Review Board.
* Successful wear of spherical daily wear frequent replacement soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months.
* Willing to stop wearing habitual contact lenses for the duration of study participation.

Exclusion Criteria

* Any condition that contraindicates contact lens wear, as determined by the Investigator.
* Any use of systemic or ocular medications that contraindicates contact lens wear, as determined by the Investigator.
* History of refractive surgery or plan to have refractive surgery during the study.
* Current or history of dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear.
* Wears 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No