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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01965262
• Other study ID #: CV13-545
• Status: Completed
• Phase: N/A
• First received: October 11, 2013
• Last updated: February 9, 2015
• Start date: April 2014
• Est. completion date: October 2014

Study information

• Verified date: February 2015
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Hema-copolymer Lens
Hema-copolymer lens pair or the Etafilcon A lens pair
• etafilcon A Lens
Hema-copolymer lens pair or the Etafilcon A lens pair

Locations

Country	Name	City	State
United Kingdom	Eurolens Research - The University of Manchester	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

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