A Comparison of Manufacturing Processes for AIR OPTIX® COLORS Contact Lens

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

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

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2012-08-31

Brief Summary

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

The purpose of this feasibility study was to compare AIR OPTIX® COLORS contact lenses manufactured using an automated process to AIR OPTIX® COLORS contact lenses manufactured using a semi-automatic process.

Related Clinical Trials

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

Evaluation of the Performance of AIR OPTIX® COLORS

NCT01338402

Myopia

COMPLETED NA

A Comparison of Silicone Hydrogel Contact Lenses: AIR OPTIX® COLORS Versus AIR OPTIX® AQUA

NCT01635920

Myopia

COMPLETED NA

Evaluation of the Cosmetic Performance of AIR OPTIX® COLORS

NCT01398787

Cosmetic Appearance

COMPLETED NA

AIR OPTIX® COLORS Registration Trial

NCT01440322

Refractive Error

COMPLETED NA

A Comparison of AIR OPTIX® COLORS Versus FRESHLOOK® COLORBLENDS

NCT01635933

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

CROSSOVER

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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

AIR OPTIX® COLORS Auto, then AIR OPTIX® COLORS Semi-auto

Lotrafilcon B contact lens with color, automated, worn first, with Lotrafilcon B contact lens with color, semi-automated, worn second. Each product worn on a daily wear basis approximately 8 hours a day, 5 days a week, for 2 weeks.

Group Type OTHER

Lotrafilcon B contact lens with color, automated

Intervention Type DEVICE

Silicone hydrogel contact lens with color manufactured via an automated process

Lotrafilcon B contact lens with color, semi-automated

Intervention Type DEVICE

Silicone hydrogel contact lens with color manufactured via a semi-automated process

AIR OPTIX® COLORS Semi-auto, then AIR OPTIX® COLORS Auto

Lotrafilcon B contact lens with color, semi-automated, worn first, with Lotrafilcon B contact lens with color, automated, worn second. Each product worn on a daily wear basis approximately 8 hours a day, 5 days a week, for 2 weeks.

Group Type OTHER

Lotrafilcon B contact lens with color, automated

Intervention Type DEVICE

Silicone hydrogel contact lens with color manufactured via an automated process

Lotrafilcon B contact lens with color, semi-automated

Intervention Type DEVICE

Silicone hydrogel contact lens with color manufactured via a semi-automated process

Interventions

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

Lotrafilcon B contact lens with color, automated

Silicone hydrogel contact lens with color manufactured via an automated process

Intervention Type DEVICE

Lotrafilcon B contact lens with color, semi-automated

Silicone hydrogel contact lens with color manufactured via a semi-automated process

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® COLORS AIR OPTIX® COLORS

Eligibility Criteria

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

Inclusion Criteria

* Able and willing to sign a written Informed Consent form.
* Cylinder ≤ -0.75 diopter (D).
* Able to achieve visual acuity (VA) of at least 20/30 Snellen in each eye at distance with contact lenses (CLCVA) and best corrected visual acuity (BCVA) ≥ 20/25.
* Have spectacles that provide acceptable vision and be willing to wear them if unable to wear the study lenses.
* Successful daily wear of single-vision spherical soft contact lenses in both eyes during the past 3 months for a minimum of 8 hours/day, 5 days/week.

Exclusion Criteria

* Eye injury or surgery within twelve weeks immediately prior to enrollment in this trial.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Currently enrolled in an ophthalmic clinical trial.
* Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of accessory solutions, as determined by the investigator.
* Pathologically dry eye.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No