A Study to Evaluate the Clinical Performance of a Novel Multipurpose Solution

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

312 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-02-28

Brief Summary

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

The objective of this study is to evaluate the clinical performance of Bausch \& Lomb investigational Multi-Purpose Solution compared to Ciba Vision Multi-Purpose Solution when used by wearers of silicone hydrogel or Group IV contact lenses.

Related Clinical Trials

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

A Study to Evaluate the Product Feasibility of a New Silicone Hydrogel Contact Lens

NCT01412983

Myopia

COMPLETED NA

A Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens

NCT01873846

Myopia

COMPLETED NA

Evaluation of Product Performance of a New Silicone Hydrogel Multifocal Contact Lens

NCT05660577

Myopia and Hyperopia and Presbyopia

COMPLETED NA

A Study to Evaluate the Product Feasibility of Two New Silicone Hydrogel Contact Lenses

NCT01583868

Myopia

COMPLETED NA

Evaluation of a New Silicone Hydrogel Contact Lens

NCT01309880

Myopia

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.

Ocular Discomfort

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

SINGLE

Investigators

Study Groups

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

Bausch & Lomb Multi-Purpose Solution

Multi-Purpose Solution to be used for disinfecting contact lenses.

Group Type EXPERIMENTAL

Bausch & Lomb Multi-Purpose Solution

Intervention Type DEVICE

Lens care product for disinfecting lenses on a daily basis.

Ciba's Multi-Purpose Solution

Multi-Purpose Solution to be used for disinfecting contact lenses.

Group Type ACTIVE_COMPARATOR

Ciba's Multi-Purpose Solution

Intervention Type DEVICE

Lens care product for disinfecting lenses on a daily basis.

Interventions

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

Bausch & Lomb Multi-Purpose Solution

Lens care product for disinfecting lenses on a daily basis.

Intervention Type DEVICE

Ciba's Multi-Purpose Solution

Lens care product for disinfecting lenses on a daily basis.

Intervention Type DEVICE

Eligibility Criteria

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

Inclusion Criteria

* Participants must be of legal age (at least 18) on the date the Informed Consent Form (ICF) is signed and with the capacity to provide voluntary informed consent.
* Participants must habitually use a lens care product for lens cleaning, disinfecting, and storage.
* Participants must wear a lens in each eye and each lens must be of the same manufacture and brand.
* Participants must agree to wear study lenses on a daily wear basis.
* Participants must be able and willing to comply with all treatment and follow-up/study procedures.

Exclusion Criteria

* Participants participating in any drug or device clinical investigation within 2 weeks prior to entry into this study and/or during the period of study participation.
* Participants with any systemic disease affecting ocular health.
* Participants using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
* Participants who have had any corneal surgery (eg, refractive surgery).
* Participants who are allergic to any component in the study care products.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes