MedDataX Logo

Comparison of a Multifocal Contact Lens to a Traditional Multifocal Contact Lens

NCT ID: NCT00886119

Last Updated: 2012-06-29

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

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2009-05-31

Brief Summary

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

The purpose of the trial is to compare the performance of two multifocal contact lens systems/products in established presbyopic subjects.

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.

Presbyopia

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

SINGLE

Participants

Study Groups

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

Lotrafilcon B / Omafilcon A

Lotrafilcon B, followed by Omafilcon A

Group Type OTHER

Lotrafilcon B multifocal contact lens

Intervention Type DEVICE

Silicone hydrogel, soft, multifocal contact lens for daily wear use

Omafilcon A multifocal contact lens

Intervention Type DEVICE

Hydrogel, soft, multifocal contact lens for daily wear use

Omafilcon A / Lotrafilcon B

Omafilcon A, followed by Lotrafilcon B

Group Type OTHER

Lotrafilcon B multifocal contact lens

Intervention Type DEVICE

Silicone hydrogel, soft, multifocal contact lens for daily wear use

Omafilcon A multifocal contact lens

Intervention Type DEVICE

Hydrogel, soft, multifocal contact lens for daily wear use

Interventions

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

Lotrafilcon B multifocal contact lens

Silicone hydrogel, soft, multifocal contact lens for daily wear use

Intervention Type DEVICE

Omafilcon A multifocal contact lens

Hydrogel, soft, multifocal contact lens for daily wear use

Intervention Type DEVICE

Eligibility Criteria

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

Inclusion Criteria

* Be at least 35 years of age.
* Best-corrected visual acuity of at least 20/40 in each eye.
* Spectacle add from +1.50D and +2.50D (inclusive).
* Able to be fit in available study sphere powers (Plano to -4.00D).
* Currently wearing soft contact lenses at least 5 days a week.

Exclusion Criteria

* Requires concurrent ocular medication.
* Eye injury or surgery within twelve weeks immediately prior to enrollment.
* Currently enrolled in an ophthalmic clinical trial.
* Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
* Previous refractive surgery.
* Astigmatism \> 1.00D.
* Currently wearing Proclear Multifocal, Frequency 55 Multifocal or Biomedics EP contact lenses.
Minimum Eligible Age

35 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

Countries

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

United States

Other Identifiers

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

P-319-C-005 sub 8

Identifier Type: -

Identifier Source: org_study_id