Ophthalmic Compatibility During Seven Days of Continuous Wear of Silicone Hydrogel Lenses

NCT ID: NCT00934102

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

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2009-09-30

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 assess the ophthalmic compatibility of three different silicone hydrogel lenses worn on an overnight basis for six nights.

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

DOUBLE

Participants Investigators

Study Groups

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

Lotrafilcon A

Lotrafilcon A, silicone hydrogel, spherical contact lens randomly assigned to one eye, worn on an extended wear basis.

Group Type ACTIVE_COMPARATOR

Lotrafilcon A contact lens

Intervention Type DEVICE

Commercially marketed, silicone hydrogel, spherical soft contact lens

Narafilcon A

Narafilcon A, silicone hydrogel, spherical contact lens randomly assigned to one eye, worn on an extended wear basis.

Group Type ACTIVE_COMPARATOR

Narafilcon A contact lens

Intervention Type DEVICE

Investigational, silicone hydrogel, spherical soft contact lens

Galyfilcon A

Galyfilcon A, silicone hydrogel, spherical contact lens randomly assigned to one eye, worn on an extended wear basis.

Group Type ACTIVE_COMPARATOR

Galyfilcon A contact lens

Intervention Type DEVICE

Commercially marketed, silicone hydrogel, spherical soft contact lens

Interventions

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

Narafilcon A contact lens

Investigational, silicone hydrogel, spherical soft contact lens

Intervention Type DEVICE

Lotrafilcon A contact lens

Commercially marketed, silicone hydrogel, spherical soft contact lens

Intervention Type DEVICE

Galyfilcon A contact lens

Commercially marketed, silicone hydrogel, spherical soft contact lens

Intervention Type DEVICE

Eligibility Criteria

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

Inclusion Criteria

* Is at least 17 years of age and has full legal capacity to volunteer
* Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual vision correction
* Has had an ocular examination in the last two years
* Is a current soft (hydrogel or silicone hydrogel) contact lens wearer
* Has clear corneas and no active ocular disease
* Can be successfully fit with the lenses to be used in the study

Exclusion Criteria

* Is pregnant or lactating
* Has undergone corneal refractive surgery
* Currently wears lenses on an extended wear basis or was on extended wear within six months prior to the study
Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

University of Waterloo

OTHER

Sponsor Role collaborator

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.

Centre for Contact Lens Research: University of Waterloo

Waterloo, Ontario, Canada

Site Status

Countries

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

Canada

Other Identifiers

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

P-368-C-103

Identifier Type: -

Identifier Source: org_study_id