MedDataX Logo

Clinical Evaluation of an Investigational Soft Contact Lens

NCT ID: NCT01254747

Last Updated: 2012-07-10

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

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2010-12-31

Brief Summary

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

The purpose of this 4-week dispensing trial is to evaluate and compare an investigational soft contact lens worn on a daily disposable basis with three other soft contact lenses also worn on a daily disposable basis.

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

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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

Delefilcon A

Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.

Group Type EXPERIMENTAL

Delefilcon A contact lens

Intervention Type DEVICE

Investigational silicone hydrogel, single vision contact lens for daily wear, daily disposable use

Lotrafilcon B

Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.

Group Type ACTIVE_COMPARATOR

Lotrafilcon B contact lens (O2 OPTIX, AIR OPTIX)

Intervention Type DEVICE

Commercially marketed silicone hydrogel, single vision contact lens for daily wear, daily disposable use

Nelfilcon A

Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.

Group Type ACTIVE_COMPARATOR

Nelfilcon A contact lens (DAILIES AquaComfort Plus)

Intervention Type DEVICE

Commercially marketed hydrogel, single vision contact lens for daily wear, daily disposable use

Narafilcon A

Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.

Group Type ACTIVE_COMPARATOR

Narafilcon A contact lens (1-DAY ACUVUE TRUEYE)

Intervention Type DEVICE

Commercially marketed (Europe) silicone hydrogel, single vision contact lens for daily wear, daily disposable use

Interventions

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

Delefilcon A contact lens

Investigational silicone hydrogel, single vision contact lens for daily wear, daily disposable use

Intervention Type DEVICE

Lotrafilcon B contact lens (O2 OPTIX, AIR OPTIX)

Commercially marketed silicone hydrogel, single vision contact lens for daily wear, daily disposable use

Intervention Type DEVICE

Nelfilcon A contact lens (DAILIES AquaComfort Plus)

Commercially marketed hydrogel, single vision contact lens for daily wear, daily disposable use

Intervention Type DEVICE

Narafilcon A contact lens (1-DAY ACUVUE TRUEYE)

Commercially marketed (Europe) silicone hydrogel, single vision contact lens for daily wear, daily disposable use

Intervention Type DEVICE

Other Intervention Names

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

DAILIES TOTAL1® O2 OPTIX® AIR OPTIX® DAILIES® AquaComfort Plus® 1-DAY ACUVUE® TRUEYE™

Eligibility Criteria

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

Inclusion Criteria

* Germany: Be of legal age.
* USA: Be of legal age or, if under legal age, have written consent of parent/guardian to participate and sign informed assent.
* Sign Informed Consent.
* Wear soft contact lenses for at least 3 months prior to the study.
* Wear soft contact lenses on a daily disposable basis, daily wear basis, or occasional extended wear basis.

Exclusion Criteria

* Eye injury or surgery within twelve weeks prior to enrollment.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Currently enrolled in any clinical trial.
* Regularly wear contact lenses on an extended/overnight basis.
* Germany: pregnant or lactating.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

CIBA VISION

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CIBA VISION Research Clinic

Duluth, Georgia, United States

Site Status

CIBA VISION Research Clinic

Großwallstadt, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P-347-C-003v2s2v2

Identifier Type: -

Identifier Source: org_study_id