A Clinical Assessment of the Hemacopolymer Daily Disposable Limbal Ring Soft Contact Lens

February 7, 2017 updated by: CooperVision, Inc.
This purpose of this study is to compare the clinical performance and subjective acceptance of two different daily disposable limbal ring lenses.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a subject-masked, dispensing study designed to evaluate the clinical performance and subjective acceptance when comparing two different daily disposable limbal ring lenses. Limbal ring lenses, which as well as correcting vision, have a colored ring which enhance the wearer's iris and are particularly popular in East Asian countries.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Manchester, United Kingdom, M13 9PL
        • Eurolens Research - The University of Manchester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Subjects will only be eligible for the study if:

  • They are 18 years of age and above.
  • They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
  • They are willing and able to follow the protocol.
  • They agree not to participate in other clinical research for the duration of this study.
  • They can attain at least 6/9 in each eye with the study lenses within the available power range.
  • They can be fitted with study lenses within the available power range.
  • The currently use soft contact lenses, or have done so within the last six months.

Exclusion Criteria:

Subjects will not be able to take part in the study if:

  • They have an ocular disorder which would normally contraindicate contact lens wear.
  • They have a systemic disorder which would normally contraindicate contact lens wear.
  • They are using any topical medication such as eye drops or ointment.
  • They have had cataract surgery.
  • They have had corneal refractive surgery.
  • They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
  • They are pregnant or lactating.
  • They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
  • They have any infectious disease which would normally contraindicate contact lens wear, or may, in the opinion of the investigator, pose a risk to study personnel; or any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reactions.
  • They have taken part in any other clinical trial or research, within two weeks prior to starting this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Hema-copolymer Lens
Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
Device: Hema-copolymer Lens
contact lens
Device: etafilcon A Lens
contact lens
ACTIVE_COMPARATOR: etafilcon A Lens
Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
Device: Hema-copolymer Lens
contact lens
Device: etafilcon A Lens
contact lens

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual Acuity - Hema-copolymer and Etafilcon A
Time Frame: Baseline
Visual acuity measured by logMAR of hema-copolymer and etafilcon A lenses assessed at baseline.
Baseline
Visual Acuity - Hema-copolymer and Etafilcon A
Time Frame: 1 week
Visual acuity measured by logMAR for hema-copolymer and etafilcon A lenses assessed at 1 week.
1 week
Biomicroscopy - Hema-copolymer and Etafilcon A
Time Frame: 1 week
Biomicroscopy is analyzed for hema-copolymer and etafilcon A at 1 week. (Scale 0-4, 0=normal, 4=severe).
1 week
Lens Surface - Deposition - Hema-copolymer and Etafilcon A
Time Frame: Baseline
Lens surface of deposition for hema-copolymer and etafilcon A pair of lenses assessed at baseline. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=absent, clean surface, 4= multiple deposits.
Baseline
Lens Surface - Deposition - Hema-copolymer and Etafilcon A
Time Frame: 1 week
Lens surface of deposition for hema-copolymer and etafilcon A pair of lenses assessed at 1 week. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=absent, clean surface, 4= multiple deposits.
1 week
Lens Surface - Debris - Hema-copolymer and Etafilcon A
Time Frame: Baseline
Lens surface of debris for hema-copolymer and etafilcon A pair of lenses assessed at baseline. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=no debris present, 4=debris present more than two thirds of area beneath lens.
Baseline
Lens Surface - Debris - Hema-copolymer and Etafilcon A
Time Frame: 1 week
Lens surface of debris for hema-copolymer and etafilcon A pair of lenses assessed at 1 week. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=no debris present, 4=debris present more than two thirds of area beneath lens.
1 week
Lens Surface - Wettability - Hema-copolymer and Etafilcon A
Time Frame: Baseline
Lens surface of wettability for hema-copolymer and etafilcon A pair of lenses assessed at baseline. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=fully wetting lens surface, 4=presence of one or more non-wetting areas.
Baseline
Lens Surface - Wettability - Hema-copolymer and Etafilcon A
Time Frame: 1 week
Lens surface of wettability for hema-copolymer and etafilcon A pair lenses assessed at 1 week. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=fully wetting lens surface, 4=presence of one or more non-wetting areas.
1 week
Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A
Time Frame: Baseline
Lens fit of horizontal centration for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal
Baseline
Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A
Time Frame: 1 week
Lens fit of horizontal centration for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal
1 week
Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A
Time Frame: Baseline
Lens fit of vertical centration for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely inferior, slightly inferior, optimum, slightly superior, extremely superior
Baseline
Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A
Time Frame: 1 week
Lens fit of vertical centration for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely inferior, slightly inferior, optimum, slightly superior, extremely superior
1 week
Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A
Time Frame: Baseline
Lens fit of corneal centration for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive
Baseline
Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A
Time Frame: 1 week
Lens fit of corneal centration for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive
1 week
Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A
Time Frame: Baseline
Lens fit of lens movement for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive
Baseline
Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A
Time Frame: 1 week
Lens fit of lens movement for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive
1 week
Comfort Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A
Time Frame: Baseline
Subjective Assessment of comfort preference for hema-copolymer and etafilcon A assessed at baseline. Scale 0-100, 0=causes pain, 100= excellent.
Baseline
Comfort Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A
Time Frame: 1 week
Subjective Assessment of comfort preference after insertion and before removal for hema-copolymer and etafilcon A lenses is assessed at 1 week. Scale 0-100, 0=causes pain, 100= excellent.
1 week
Vision Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A
Time Frame: Baseline
Subjective Assessment of vision preference for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=unacceptable, 100= excellent.
Baseline
Vision Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A
Time Frame: 1 week
Subjective Assessment of vision preference for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=unacceptable, 100= excellent.
1 week
Peripheral Blur (Subjective Assessment) - Hema-copolymer and Etafilcon A
Time Frame: Baseline
Subjective Assessment of peripheral blur is assessed at baseline. Scale 0-100, 0=unacceptable, 100= excellent.
Baseline
Peripheral Blur (Subjective Assessment) - Hema-copolymer and Etafilcon A
Time Frame: 1 week
Subjective Assessment of peripheral blur assessed at 1 week. Scale 0-100, 0=unacceptable, 100= excellent.
1 week
Ocular Redness (Subjective Assessment) - Hema-copolymer and Etafilcon A
Time Frame: 1 week
Subjective Assessment of ocular redness for hema-copolymer and etafilcon A lenses lenses assessed at 1 week. Scale 0-100, 0=extremely poor, 100= excellent.
1 week
Handling (Subjective Assessment) - Hema-copolymer and Etafilcon A
Time Frame: 1 week
Subjective Assessment of handling (ease of insertion and ease of removal) for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=unmanageable, 100= excellent.
1 week
Attractiveness (Subjective Assessment) - Hema-copolymer and Etafilcon A
Time Frame: Baseline
Subjective Assessment of attractiveness for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=extremely poor, 100= excellent.
Baseline
Attractiveness (Subjective Assessment) - Hema-copolymer and Etafilcon A
Time Frame: 1 week
Subjective Assessment of attractiveness for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=extremely poor, 100= excellent.
1 week
Overall Impression (Subjective Assessment) - Hema-copolymer and Etafilcon A
Time Frame: Baseline
Subjective assessment of the overall impression for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=extremely poor, 100= excellent.
Baseline
Overall Impression (Subjective Assessment) - Hema-copolymer and Etafilcon A
Time Frame: 1 week
Subjective assessment of the overall impression for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=extremely poor, 100= excellent.
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CooperVision, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Carole Maldonado-Codinal, PhD, Eurolens Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 11, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2013

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 16, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CV13-545

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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