Clinical Assessment of a HYDRAGLYDE® Regimen

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

323 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-13

Study Completion Date

2017-08-18

Brief Summary

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

The purpose of this study is to evaluate worn AIR OPTIX® plus HYDRAGLYDE® (AOHG) lenses cleaned and disinfected with HYDRAGLYDE® containing lens solutions compared to each of the control habitual silicone hydrogel (SiHy) lenses cleaned and disinfected with habitual multi-purpose solution (MPS) for cholesterol uptake.

Related Clinical Trials

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

The Clinical Performance of Two Reusable Silicone Hydrogel Contact Lenses

NCT05766787

Refractive Ametropia

COMPLETED NA

Assessing the Clinical Performance of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses

NCT05702541

Presbyopia

COMPLETED NA

Clinical Performance of Two Reusable Silicone Hydrogel Contact Lenses

NCT05431478

Refractive Errors

COMPLETED NA

Comparative In-Vivo Wetting Characteristics of Silicone Hydrogel Materials With Selected Lens Care Systems

NCT01699750

Myopia Astigmatism Refractive Error

COMPLETED NA

Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Toric Contact Lenses

NCT05959200

Ametropia Myopia Hyperopia +1 more

COMPLETED NA

Detailed Description

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

Conditions

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

Refractive Errors Myopia Hypermetropia

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

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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

AOHG

Lotrafilcon B contact lenses with added wetting agent, worn bilaterally (in both eyes) for 30 days in a daily wear modality and cared for with either a hydrogen peroxide-based contact lens solution with added wetting agent or a POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent, as randomized

Group Type EXPERIMENTAL

Lotrafilcon B contact lenses with added wetting agent

Intervention Type DEVICE

Silicone hydrogel contact lenses

POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent

Intervention Type DEVICE

Multi-purpose disinfecting solution for contact lens care

Hydrogen peroxide-based contact lens solution with added wetting agent

Intervention Type DEVICE

Solution for contact lens cleaning and disinfecting

Habitual

Habitual silicone hydrogel contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual multi-purpose solution (MPS)

Group Type ACTIVE_COMPARATOR

Samfilcon A contact lenses

Intervention Type DEVICE

Habitual silicone hydrogel contact lenses

Senofilcon C contact lenses

Intervention Type DEVICE

Habitual silicone hydrogel contact lenses

Senofilcon A contact lenses

Intervention Type DEVICE

Habitual silicone hydrogel contact lenses with a replacement pair issued after 2 weeks

Comfilcon A contact lenses

Intervention Type DEVICE

Habitual silicone hydrogel contact lenses

Habitual Multi-Purpose Solution (HMPS)

Intervention Type DEVICE

Multi-purpose solution for contact lens care according to participant's habitual brand, used per manufacturer's instructions

Interventions

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

Lotrafilcon B contact lenses with added wetting agent

Silicone hydrogel contact lenses

Intervention Type DEVICE

Samfilcon A contact lenses

Habitual silicone hydrogel contact lenses

Intervention Type DEVICE

POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent

Multi-purpose disinfecting solution for contact lens care

Intervention Type DEVICE

Hydrogen peroxide-based contact lens solution with added wetting agent

Solution for contact lens cleaning and disinfecting

Intervention Type DEVICE

Senofilcon C contact lenses

Habitual silicone hydrogel contact lenses

Intervention Type DEVICE

Senofilcon A contact lenses

Habitual silicone hydrogel contact lenses with a replacement pair issued after 2 weeks

Intervention Type DEVICE

Comfilcon A contact lenses

Habitual silicone hydrogel contact lenses

Intervention Type DEVICE

Habitual Multi-Purpose Solution (HMPS)

Multi-purpose solution for contact lens care according to participant's habitual brand, used per manufacturer's instructions

Intervention Type DEVICE

Other Intervention Names

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

AIR OPTIX® plus HYDRAGLYDE® (AOHG) Bausch + Lomb ULTRA™ (Ultra) OPTI-FREE® PureMoist® (OFPM) CLEAR CARE® PLUS/AOSEPT® PLUS with HYDRAGLYDE® (CCP) Johnson & Johnson ACUVUE® VITA™ (Vita) Johnson & Johnson ACUVUE® OASYS® 2- Week with HYDRACLEAR® PLUS (Oasys) CooperVision® Biofinity® (Biofinity)

Eligibility Criteria

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

Inclusion Criteria

* Must sign informed consent document;
* Vision correctable to 0.1 (LogMAR) or better in each eye at distance with habitual lenses;
* Manifest cylinder (at screening) less than or equal to 0.75 diopter (D) in each eye and spectacle add \<+0.50 D in each eye;
* Current full-time wearer of spherical samfilcon A, comfilcon A, senofilcon C monthly or senofilcon A 2-week replacement lens within the power range of lens powers available;
* Current user of an MPS (excluding OFPM) to care for lenses;
* Willing to answer text messages on a daily basis during the study;
* Willing to discontinue artificial tears during the study and rewetting drops on the days of study visits;
* Use of digital devices (eg, smart phone, tablet, laptop or desktop computer) for 20 consecutive minutes at least twice a week and willing to continue for the duration of the study;

Exclusion Criteria

* Habitual lens wear in an extended wear modality (routinely sleeping in lenses overnight for 1 or more nights per week);
* Any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear;
* History of herpetic keratitis, corneal surgery or irregular cornea;
* Prior refractive surgery;
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator;
* Currently using or have not discontinued Restasis®, Xiidra™ and/or topical steroids within the past 7 days;
* Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study;
* Monocular (only 1 eye with functional vision) or fit with only 1 lens;
* Known pregnancy or lactating;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No