Daily Disposable Contact Lens Tear Film Study

NCT ID: NCT01473160

Last Updated: 2013-04-17

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

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2011-12-31

Brief Summary

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

The purpose of this study was to evaluate the pre-lens tear film stability of a new CE-marked daily disposable contact lens as compared to a commercially available 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.

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

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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

delefilcon A

Delefilcon A randomly assigned to one eye, with narafilcon A assigned to the fellow eye for contralateral wear. Both products will be worn for one day for 16 hours (+/- 1 hour).

Group Type EXPERIMENTAL

delefilcon A contact lens

Intervention Type DEVICE

CE-marked, silicone hydrogel, single vision, soft contact lens for daily disposable wear

narafilcon A

Narafilcon A randomly assigned to one eye, with delefilcon A assigned to the fellow eye for contralateral wear. Both products will be worn for one day for 16 hours (+/- 1 hour).

Group Type ACTIVE_COMPARATOR

narafilcon A contact lens

Intervention Type DEVICE

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

Interventions

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

delefilcon A contact lens

CE-marked, silicone hydrogel, single vision, soft contact lens for daily disposable wear

Intervention Type DEVICE

narafilcon A contact lens

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

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 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

* Be of legal age of consent and sign Informed Consent document.
* Willing and able to wear spherical contact lenses for 16 hours.
* Willing and able to wear spherical contact lenses within the available range of powers.
* Best corrected spectacle visual acuity equal or better than 20/25 or 6/7.5.

Exclusion Criteria

* Anterior segment infection, inflammation, or abnormality.
* Any use of systemic medications for which contact lens wear could be contraindicated.
* History of refractive surgery or irregular cornea.
* Currently enrolled in any clinical trial.
* Eye injury within twelve weeks prior to enrollment.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

Aston University

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.

Aston University

Birmingham, , 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.

P-347-C-014v2

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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