Daily Disposable Toric Comparative Trial in Europe

NCT ID: NCT01070381

Last Updated: 2013-12-13

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

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-03-31

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 is to investigate the subjective and objective performance of two daily disposable lenses for wearers with astigmatism.

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 Astigmatism

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

NONE

Study Groups

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

nelfilcon A / ocufilcon D

Nelfilcon A contact lenses worn first, with ocufilcon D contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.

Group Type OTHER

nelfilcon A contact lens

Intervention Type DEVICE

Commercially marketed, toric, soft contact lens for daily disposable wear

ocufilcon D contact lens

Intervention Type DEVICE

Commercially marketed, toric, soft contact lens for daily disposable wear

ocufilcon D / nelfilcon A

Ocufilcon D contact lenses worn first, with nelfilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.

Group Type OTHER

nelfilcon A contact lens

Intervention Type DEVICE

Commercially marketed, toric, soft contact lens for daily disposable wear

ocufilcon D contact lens

Intervention Type DEVICE

Commercially marketed, toric, 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.

nelfilcon A contact lens

Commercially marketed, toric, soft contact lens for daily disposable wear

Intervention Type DEVICE

ocufilcon D contact lens

Commercially marketed, toric, soft contact lens for daily disposable wear

Intervention Type DEVICE

Eligibility Criteria

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

Inclusion Criteria

* Current soft contact lens wearers able to be fit with soft toric lenses in the protocol-specified parameters.
* Achieve 0.5 or better distance visual acuity in each eye at time of dispense.
* Achieve acceptable or optimal fit in each eye at time of dispense.

Exclusion Criteria

* Habitual daily disposable contact lens wearer.
* Sleeps in contact lenses overnight.
* Currently enrolled in an ophthalmic clinical trial.
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

Countries

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

Germany

Other Identifiers

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

P-346-C-008

Identifier Type: -

Identifier Source: org_study_id