A Comparison of Two Daily Disposable Contact Lenses.

NCT ID: NCT00721500

Last Updated: 2015-05-21

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

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2008-07-31

Brief Summary

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

This study seeks to evaluate the clinical fitting performance of a new daily disposable contact lens to an existing daily disposable contact lens.

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.

Refractive Error 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.

narafilcon A / etafilcon A - etafilcon A - narafilcon A

First, narafilcon A and etafilcon A contact lenses worn contralaterally. Second, etafilcon A contact lenses worn in both eyes. Third, narafilcon A contact lenses worn in both eyes.

Group Type EXPERIMENTAL

etafilcon A

Intervention Type DEVICE

contact lens

narafilcon A

Intervention Type DEVICE

contact lens

narafilcon A / etafilcon A - narafilcon A - etafilcon A

First, narafilcon A and etafilcon A contact lenses worn contralaterally. Second, narafilcon A contact lenses worn in both eyes. Third, etafilcon A contact lenses worn in both eyes.

Group Type EXPERIMENTAL

etafilcon A

Intervention Type DEVICE

contact lens

narafilcon A

Intervention Type DEVICE

contact lens

narafilcon A - etafilcon A - narafilcon A / etafilcon A

First, narafilcon A contact lenses worn in both eyes. Second, etafilcon A contact lenses worn in both eyes. Third, narafilcon A and etafilcon A contact lenses worn contralaterally.

Group Type EXPERIMENTAL

etafilcon A

Intervention Type DEVICE

contact lens

narafilcon A

Intervention Type DEVICE

contact lens

etafilcon A - narafilcon A - narafilcon A / etafilcon A

First, etafilcon A contact lenses worn in both eyes. Second, narafilcon A contact lenses worn in both eyes. Third, narafilcon A and etafilcon A contact lenses worn contralaterally.

Group Type EXPERIMENTAL

etafilcon A

Intervention Type DEVICE

contact lens

narafilcon A

Intervention Type DEVICE

contact lens

Interventions

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

etafilcon A

contact lens

Intervention Type DEVICE

narafilcon A

contact lens

Intervention Type DEVICE

Other Intervention Names

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

1-Day Acuvue Moist TruEye

Eligibility Criteria

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

Inclusion Criteria

* They are of legal age (18 years) and capacity to volunteer.
* They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
* They are willing and able to follow the protocol.
* They would be expected to attain at least 6/9 (20/30) in each eye with the study lenses.
* They are able to wear contact lenses with a back vertex power of -1.00 to -6.00DS.
* They have a maximum of 1.00D of refractive astigmatism (i.e. ≤ 1.00 DC).
* They have successfully worn contact lenses within six months of starting the study.

Exclusion Criteria

* They have an ocular disorder which would normally contra-indicate contact lens wear.
* They have a systemic disorder which would normally contra-indicate contact lens wear.
* They are using any topical medication such as eye drops or ointment.
* They are aphakic.
* They have had corneal refractive surgery.
* They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus.
* They are pregnant or lactating.
* They have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.
* They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV).
* They have diabetes.
* They have taken part in any other clinical trial or research, within two weeks prior to starting this study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

Visioncare Research Ltd.

OTHER

Sponsor Role collaborator

Johnson & Johnson Vision Care, Inc.

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.

Visioncare Research Ltd

Farnham, Surrey, United Kingdom

Site Status

Countries

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

United Kingdom

Other Identifiers

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

PROD-502

Identifier Type: -

Identifier Source: secondary_id

CR-0812

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.