MedDataX Logo

Comparison of Clinical Performance and Subjective Preference of Three Contact Lenses

NCT ID: NCT03134599

Last Updated: 2019-12-19

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-23

Study Completion Date

2017-06-24

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 evaluate the clinical performance and subject's preference out of three LRE (Limbal Ring Enhancing) lens types: etafilcon A (Johnson\&Johnson), methafilcon A (Interozzo), and methafilcon A (CooperVision).

Detailed Description

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

This will be a subject-masked, bilateral, randomized, crossover dispensing study to compare clinical performance and subjective preference out of three lens types. Sixty subjects will be assigned into three groups and each group will wear the test and control lenses as matched pairs for one week in random order. Lenses will be worn on a daily wear, daily disposable schedule.

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

SINGLE

Participants

Study Groups

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

etafilcon A

Group Type ACTIVE_COMPARATOR

etafilcon A

Intervention Type DEVICE

contact lens

methafilcon A - Interozzo

Group Type ACTIVE_COMPARATOR

methafilcon A - Interozzo

Intervention Type DEVICE

contact lens

methafilcon A - CVI

Group Type ACTIVE_COMPARATOR

methafilcon A - CVI (CooperVision)

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

methafilcon A - Interozzo

contact lens

Intervention Type DEVICE

methafilcon A - CVI (CooperVision)

contact lens

Intervention Type DEVICE

Eligibility Criteria

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

Inclusion Criteria

* Age of 18 years and above and has full legal capacity as a volunteer Understand the rights as a research subject and willing and able sign a statement of informed consent
* Existing soft contact lens wearers or previous experience of contact lens wear
* Being able to wear the study lenses for at least eight hours a day
* At least 6/9 visual acuity in each eye with the study lenses
* Astigmatism less than 1.50 D (Diopter) in both eyes
* Agreed to follow the protocol and not to participate in other clinical research for the duration of this study

Exclusion Criteria

* Have an ocular disorder which would normally contraindicate contact lens wear
* Have a systemic disorder or any infectious diseases which would normally contraindicate contact lens wear
* Have previously had any ocular surgery such as corneal refractive surgery
* Have less than 6/9 visual acuity in each eye with the study lenses
* Are currently using any topical medication such as eye drops or ointment
* Have any corneal distortion resulting from previous rigid lens wear or have keratoconus
* Are currently pregnant or lactating
* No previous contact lens wear
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.

CooperVision, 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.

School of Optometry & Vision Science, Catholic University of Daegu, Korea (Rep)

Daegu, , South Korea

Site Status

Countries

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

South Korea

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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

CV_BSCHU

Identifier Type: -

Identifier Source: org_study_id