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

Not Applicable

Completed

Conditions: Myopia

Interventions: Device: Hema-copolymer Lens
Device: etafilcon A Lens

Registration Number: NCT01965262

Lead Sponsor: Coopervision, Inc.

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

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

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 & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
etafilcon A Lens	Hema-copolymer Lens	Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
Hema-copolymer Lens	etafilcon A Lens	Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
etafilcon A Lens	etafilcon A Lens	Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.
Hema-copolymer Lens	Hema-copolymer Lens	Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.

Primary Outcome Measures

Name	Time	Method
Lens Surface - Wettability - Hema-copolymer and Etafilcon A	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.
Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A	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
Biomicroscopy - Hema-copolymer and Etafilcon A	1 week	Biomicroscopy is analyzed for hema-copolymer and etafilcon A at 1 week. (Scale 0-4, 0=normal, 4=severe).
Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A	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
Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A	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
Overall Impression (Subjective Assessment) - Hema-copolymer and Etafilcon A	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.
Visual Acuity - Hema-copolymer and Etafilcon A	1 week	Visual acuity measured by logMAR for hema-copolymer and etafilcon A lenses assessed at 1 week.
Lens Surface - Deposition - Hema-copolymer and Etafilcon A	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.
Lens Surface - Debris - Hema-copolymer and Etafilcon A	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.
Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A	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
Peripheral Blur (Subjective Assessment) - Hema-copolymer and Etafilcon A	1 week	Subjective Assessment of peripheral blur assessed at 1 week. Scale 0-100, 0=unacceptable, 100= excellent.
Ocular Redness (Subjective Assessment) - Hema-copolymer and Etafilcon A	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.
Handling (Subjective Assessment) - Hema-copolymer and Etafilcon A	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.
Attractiveness (Subjective Assessment) - Hema-copolymer and Etafilcon A	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.
Comfort Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A	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.
Vision Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A	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.