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

N/ACompletedNCT01965262

CooperVision, Inc.30 enrolled

Overview

This purpose of this study is to compare the clinical performance and subjective acceptance of two different daily disposable limbal ring lenses.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Myopia

Interventions

Hema-copolymer LensDEVICE

contact lens

etafilcon A LensDEVICE

contact lens

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Eurolens Research - The University of Manchester

Manchester, United Kingdom

Outcomes

Primary Outcomes

Visual Acuity - Hema-copolymer and Etafilcon A

Visual acuity measured by logMAR of hema-copolymer and etafilcon A lenses assessed at baseline.

Time frame: Baseline

Visual Acuity - Hema-copolymer and Etafilcon A

Visual acuity measured by logMAR for hema-copolymer and etafilcon A lenses assessed at 1 week.

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline

Lens Surface - Debris - Hema-copolymer and Etafilcon A

Data from ClinicalTrials.gov

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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.

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.

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 1 week