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

NCT01965262 | Completed Results

• 1 other identifier: CV13-545
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Myopia

Outcome Measures

Primary Outcomes (29)

• Visual Acuity - Hema-copolymer and Etafilcon A

  Visual acuity measured by logMAR of hema-copolymer and etafilcon A lenses assessed at baseline.

  Baseline

• Visual Acuity - Hema-copolymer and Etafilcon A

  Visual acuity measured by logMAR for hema-copolymer and etafilcon A lenses assessed at 1 week.

  1 week

• Biomicroscopy - Hema-copolymer and Etafilcon A

  Biomicroscopy is analyzed for hema-copolymer and etafilcon A at 1 week. (Scale 0-4, 0=normal, 4=severe).

  1 week

• Lens Surface - Deposition - Hema-copolymer and Etafilcon A

  Lens surface of deposition for hema-copolymer and etafilcon A pair of lenses assessed at baseline. (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.

  Baseline

• Lens Surface - Deposition - Hema-copolymer and Etafilcon A

  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.

  1 week

• Lens Surface - Debris - Hema-copolymer and Etafilcon A

  Lens surface of debris for hema-copolymer and etafilcon A pair of lenses assessed at baseline. (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.

  Baseline

• Lens Surface - Debris - Hema-copolymer and Etafilcon A

  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.

  1 week

• Lens Surface - Wettability - Hema-copolymer and Etafilcon A

  Lens surface of wettability for hema-copolymer and etafilcon A pair of lenses assessed at baseline. (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.

  Baseline

• Lens Surface - Wettability - Hema-copolymer and Etafilcon A

  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.

  1 week

• Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A

  Lens fit of horizontal centration for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal

  Baseline

• Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A

  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

  1 week

• Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A

  Lens fit of vertical centration for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely inferior, slightly inferior, optimum, slightly superior, extremely superior

  Baseline

• Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A

  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

  1 week

• Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A

  Lens fit of corneal centration for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive

  Baseline

• Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A

  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

  1 week

• Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A

  Lens fit of lens movement for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive

  Baseline

• Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A

  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

  1 week

• Comfort Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A

  Subjective Assessment of comfort preference for hema-copolymer and etafilcon A assessed at baseline. Scale 0-100, 0=causes pain, 100= excellent.

  Baseline

• Comfort Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A

  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.

  1 week

• Vision Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A

  Subjective Assessment of vision preference for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=unacceptable, 100= excellent.

  Baseline

• Vision Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A

  Subjective Assessment of vision preference for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=unacceptable, 100= excellent.

  1 week

• Peripheral Blur (Subjective Assessment) - Hema-copolymer and Etafilcon A

  Subjective Assessment of peripheral blur is assessed at baseline. Scale 0-100, 0=unacceptable, 100= excellent.

  Baseline

• Peripheral Blur (Subjective Assessment) - Hema-copolymer and Etafilcon A

  Subjective Assessment of peripheral blur assessed at 1 week. Scale 0-100, 0=unacceptable, 100= excellent.

  1 week

• Ocular Redness (Subjective Assessment) - Hema-copolymer and Etafilcon A

  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.

  1 week

• Handling (Subjective Assessment) - Hema-copolymer and Etafilcon A

  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.

  1 week

• Attractiveness (Subjective Assessment) - Hema-copolymer and Etafilcon A

  Subjective Assessment of attractiveness for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=extremely poor, 100= excellent.

  Baseline

• Attractiveness (Subjective Assessment) - Hema-copolymer and Etafilcon A

  Subjective Assessment of attractiveness for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=extremely poor, 100= excellent.

  1 week

• Overall Impression (Subjective Assessment) - Hema-copolymer and Etafilcon A

  Subjective assessment of the overall impression for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=extremely poor, 100= excellent.

  Baseline

• Overall Impression (Subjective Assessment) - Hema-copolymer and Etafilcon A

  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.

  1 week

Study Arms (2)

Hema-copolymer Lens

ACTIVE COMPARATOR

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

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

etafilcon A Lens

ACTIVE COMPARATOR

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

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

Interventions

Hema-copolymer Lens DEVICE

contact lens

Hema-copolymer Lens; etafilcon A Lens

etafilcon A Lens DEVICE

contact lens

Hema-copolymer Lens; etafilcon A Lens

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

Eurolens Research - The University of Manchester

Manchester, M13 9PL, United Kingdom

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Paul Chamberlain, BSc Honors, Sr. Manager Clinical Research
• Organization: Coopervision

pchamberlain@coopervision.com

(925) 730-6754

Study Officials

• Carole Maldonado-Codinal, PhD

  Eurolens Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2013
• First Posted: October 18, 2013
• Study Start: April 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: October 1, 2014
• Last Updated: March 16, 2017
• Results First Posted: April 18, 2016

Record last verified: 2017-02

Locations

GB (1)