Clinical trial NCT01965262: A Clinical Assessment of the Hemacopolymer Daily Disposable Limbal Ring Soft Contact Lens
Official title: A Clinical Assessment of the Hemacopolymer Daily Disposable Limbal Ring Soft Contact Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2013-10-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Visual Acuity - Hema-copolymer and Etafilcon A
timeFrame: Baseline
measure: Visual Acuity - Hema-copolymer and Etafilcon A
timeFrame: 1 week
measure: Biomicroscopy - Hema-copolymer and Etafilcon A
timeFrame: 1 week
measure: Lens Surface - Deposition - Hema-copolymer and Etafilcon A
timeFrame: Baseline
measure: Lens Surface - Deposition - Hema-copolymer and Etafilcon A
timeFrame: 1 week
measure: Lens Surface - Debris - Hema-copolymer and Etafilcon A
timeFrame: Baseline
measure: Lens Surface - Debris - Hema-copolymer and Etafilcon A
timeFrame: 1 week
measure: Lens Surface - Wettability - Hema-copolymer and Etafilcon A
timeFrame: Baseline
measure: Lens Surface - Wettability - Hema-copolymer and Etafilcon A
timeFrame: 1 week
measure: Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A
timeFrame: Baseline
measure: Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A
timeFrame: 1 week
measure: Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A
timeFrame: Baseline
measure: Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A
timeFrame: 1 week
measure: Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A
timeFrame: Baseline
measure: Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A
timeFrame: 1 week
measure: Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A
timeFrame: Baseline
measure: Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A
timeFrame: 1 week
measure: Comfort Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A
timeFrame: Baseline
measure: Comfort Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A
timeFrame: 1 week
measure: Vision Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A
timeFrame: Baseline
measure: Vision Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A
timeFrame: 1 week
measure: Peripheral Blur (Subjective Assessment) - Hema-copolymer and Etafilcon A
timeFrame: Baseline
measure: Peripheral Blur (Subjective Assessment) - Hema-copolymer and Etafilcon A
timeFrame: 1 week
measure: Ocular Redness (Subjective Assessment) - Hema-copolymer and Etafilcon A
timeFrame: 1 week
measure: Handling (Subjective Assessment) - Hema-copolymer and Etafilcon A
timeFrame: 1 week
measure: Attractiveness (Subjective Assessment) - Hema-copolymer and Etafilcon A
timeFrame: Baseline
measure: Attractiveness (Subjective Assessment) - Hema-copolymer and Etafilcon A
timeFrame: 1 week
measure: Overall Impression (Subjective Assessment) - Hema-copolymer and Etafilcon A
timeFrame: Baseline
measure: Overall Impression (Subjective Assessment) - Hema-copolymer and Etafilcon A
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Eurolens Research - The University of Manchester
Study officials:
affiliation: Eurolens Research
name: Carole Maldonado-Codinal, PhD
role: PRINCIPAL_INVESTIGATOR
References: