MedDataX Logo

Performance Evaluation of a New Daily Disposable Silicone Hydrogel Lens

NCT ID: NCT01371552

Last Updated: 2012-10-31

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

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2011-08-31

Brief Summary

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

The purpose of this study was to compare a new daily disposable, silicone hydrogel contact lens to marketed daily disposable, silicone hydrogel contact lenses.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Part 1 of the study involved bilateral wear of three different types of marketed contact lenses. Each type of lens was worn for three consecutive days of daily disposable wear. Participants had been previously identified as symptomatic lens wearers or asymptomatic lens wearers, based upon their responses to a screening questionnaire. Participants wore each lens type for as long as they were comfortable during the day, but lenses were removed before sleep. After completion of Part 1, participants began Part 2, which included dispensing of the investigational study lens for up to one week of bilateral wear, with a single follow-up visit at the end of that period.

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

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.

delefilcon A

Part 1: Delefilcon A contact lenses, followed by filcon II 3 contact lenses and narafilcon A contact lenses (in randomized order). Each product worn for three consecutive days, with a minimum 1-day washout between each product. At the conclusion of this wear cycle, the delefilcon A contact lenses were worn in Part 2 for one additional week. All products worn bilaterally in a daily wear, daily disposable modality.

Group Type EXPERIMENTAL

delefilcon A contact lens

Intervention Type DEVICE

Investigational, silicone hydrogel, single vision contact lens worn on a daily disposable basis for 3 days in Part 1 and one week in Part 2.

filcon II 3 contact lenses

Intervention Type DEVICE

Commercially marketed, silicone hydrogel, single vision contact lens worn on a daily disposable basis for 3 days in Part 1.

narafilcon A contact lenses

Intervention Type DEVICE

Commercially marketed, silicone hydrogel, single vision contact lens worn on a daily disposable basis for 3 days in Part 1.

filcon II 3

Part 1: Filcon II 3 contact lenses, followed by narafilcon A contact lenses and delefilcon A contact lenses (in randomized order). Each product worn for three consecutive days, with a minimum 1-day washout between each product. At the conclusion of this wear cycle, the delefilcon A contact lenses were worn in Part 2 for one additional week. All products worn bilaterally in a daily wear, daily disposable modality.

Group Type ACTIVE_COMPARATOR

delefilcon A contact lens

Intervention Type DEVICE

Investigational, silicone hydrogel, single vision contact lens worn on a daily disposable basis for 3 days in Part 1 and one week in Part 2.

filcon II 3 contact lenses

Intervention Type DEVICE

Commercially marketed, silicone hydrogel, single vision contact lens worn on a daily disposable basis for 3 days in Part 1.

narafilcon A contact lenses

Intervention Type DEVICE

Commercially marketed, silicone hydrogel, single vision contact lens worn on a daily disposable basis for 3 days in Part 1.

narafilcon A

Part 1: Narafilcon A contact lenses, followed by filcon II 3 contact lenses and delefilcon A contact lenses (in randomized order). Each product worn for three consecutive days, with a minimum 1-day washout between each product. At the conclusion of this wear cycle, the delefilcon A contact lenses were worn in Part 2 for one additional week. All products worn bilaterally in a daily wear, daily disposable modality.

Group Type ACTIVE_COMPARATOR

delefilcon A contact lens

Intervention Type DEVICE

Investigational, silicone hydrogel, single vision contact lens worn on a daily disposable basis for 3 days in Part 1 and one week in Part 2.

filcon II 3 contact lenses

Intervention Type DEVICE

Commercially marketed, silicone hydrogel, single vision contact lens worn on a daily disposable basis for 3 days in Part 1.

narafilcon A contact lenses

Intervention Type DEVICE

Commercially marketed, silicone hydrogel, single vision contact lens worn on a daily disposable basis for 3 days in Part 1.

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 worn on a daily disposable basis for 3 days in Part 1 and one week in Part 2.

Intervention Type DEVICE

filcon II 3 contact lenses

Commercially marketed, silicone hydrogel, single vision contact lens worn on a daily disposable basis for 3 days in Part 1.

Intervention Type DEVICE

narafilcon A contact lenses

Commercially marketed, silicone hydrogel, single vision contact lens worn on a daily disposable basis for 3 days in Part 1.

Intervention Type DEVICE

Other Intervention Names

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

Clariti 1-DAY 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

* 17 years of age; full legal capacity to volunteer.
* Ocular examination within the last two years
* Correctable to a visual acuity of 20/30 or better (in each eye) with habitual vision correction.
* Currently wearing soft contact lenses.
* Clear corneas; no active ocular disease.

Exclusion Criteria

* Currently wearing 1-DAY ACUVUE TruEye or Sauflon Clariti 1-DAY contact lenses.
* Monovision.
* Any ocular disease.
* Never worn contact lenses before.
* Corneal refractive surgery.
* Uses topical ocular medicine.
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.

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

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lyndon Jones, PhD FAAO

Role: PRINCIPAL_INVESTIGATOR

Centre for Contact Lens Research, School of Optometry, University of Waterloo

Locations

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

University of Waterloo Centre for Contact Lens Research

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/319/08/C

Identifier Type: OTHER

Identifier Source: secondary_id

P-371-C-100 v2

Identifier Type: -

Identifier Source: org_study_id