A Study to Evaluate the Safety and Efficacy of a New Silicone Hydrogel Contact Lens Design

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

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-01-31

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 safety and efficacy of a new silicone hydrogel contact lens compared to the Bausch + Lomb PureVision contact lens when worn by adapted soft contact lens wearers.

Related Clinical Trials

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

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

NCT01873846

Myopia

COMPLETED NA

Silicone Hydrogel Soft Contact Lens 7-Day Extended Wear Basis

NCT02939950

Myopia

COMPLETED NA

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

NCT01412983

Myopia

COMPLETED NA

A Study to Evaluate a New Silicone Hydrogel Contact Lens

NCT01309893

Myopia

COMPLETED NA

Feasibility of a New Silicone Hydrogel Lens

NCT01131130

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.

Myopia

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

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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

B&L Investigational Contact Lens

The Bausch + Lomb investigational silicone hydrogel contact lens

Group Type EXPERIMENTAL

B&L Investigational Contact Lens

Intervention Type DEVICE

Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly.

B&L PureVision Contact Lens

The Bausch + Lomb PureVision silicone hydrogel contact lens

Group Type ACTIVE_COMPARATOR

B&L PureVision Contact Lens

Intervention Type DEVICE

Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly.

Interventions

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

B&L Investigational Contact Lens

Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly.

Intervention Type DEVICE

B&L PureVision Contact Lens

Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly.

Intervention Type DEVICE

Eligibility Criteria

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

Inclusion Criteria

* Subjects must have clear central corneas and be free of any anterior segment disorders.
* Subjects must be myopic, and wear contact lenses in each eye.
* Subjects must be adapted soft contact lens wearers and agree to wear their study lenses on a daily wear basis for approximately 3 months.

Exclusion Criteria

* Subjects who are older than age 40 on the date the informed consent (ICF) is signed.
* Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study.
* Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
* Subjects with an active ocular disease or who are using any ocular medication.
* Subjects with any grade 2 or greater finding during the slit lamp examination.
* Subjects with corneal infiltrates, of ANY GRADE, are not eligible.
* Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
* Subjects who are allergic to any component in the study care products.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No