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

Condition(s): Myopia
NCTId: NCT01965262

Official Title

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

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.

Eligibility

Eligibility Criteria

Gender Minimum Age Maximum Age Healthy Volunteers?
Both 18 Years N/A False

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.

Interventions & Outcomes

Study Interventions & Types

Device Intervention(s)

etafilcon A Lens - Hema-copolymer lens pair or the Etafilcon A lens pair
Hema-copolymer Lens - Hema-copolymer lens pair or the Etafilcon A lens pair

Study Outcomes

Primary Outcome(s)

Timeframe: Change from baseline over 2 weeks
Measure: Subjective Assessment: Changes in overall comfort preference, Overall score measured by Vertical Visual Analog Scales (0-100)
Description: Subjective Assessment: Comfort, Vision, Attractiveness of lens, Overall score measured by Vertical Visual Analog Scales (0-100)
Safety Issue? No

Facility Locations

Research Study Facility Map

Map of facility locations for this research study.

Facility is recruiting
Facility is not yet recruiting
Unknown status

Clinical Research Study Facility Locations

Recruiting

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

Related Keywords & Studies

Conditions and Diseases with Related Research Studies

  1. Myopia

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