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

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: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Hema-copolymer Lens; Device: etafilcon A Lens

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: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Visual Acuity - Hema-copolymer and Etafilcon A	Visual acuity measured by logMAR of hema-copolymer and etafilcon A lenses assessed at baseline.	Baseline
Visual Acuity - Hema-copolymer and Etafilcon A	Visual acuity measured by logMAR for hema-copolymer and etafilcon A lenses assessed at 1 week.	1 week
Biomicroscopy - Hema-copolymer and Etafilcon A	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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

• Sponsor: CooperVision, Inc.
• Investigators: Principal Investigator: Carole Maldonado-Codinal, PhD, Eurolens Research

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (ACTUAL): May 1, 2014
• Study Completion (ACTUAL): October 1, 2014

Study Registration Dates

• First Submitted: October 11, 2013
• First Submitted That Met QC Criteria: October 15, 2013
• First Posted (ESTIMATE): October 18, 2013

Study Record Updates

• Last Update Posted (ACTUAL): March 16, 2017
• Last Update Submitted That Met QC Criteria: February 7, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CV13-545