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

CooperVision

Status: Completed

Conditions: Myopia

Treatments: Device: etafilcon A Lens; Device: Hema-copolymer Lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT01965262

CV13-545

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Hema-copolymer Lens

Active Comparator group

Description:

Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.

Treatment:

Device: etafilcon A Lens

Device: Hema-copolymer Lens

etafilcon A Lens

Active Comparator group

Description:

Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.

Treatment:

Device: etafilcon A Lens

Device: Hema-copolymer Lens