The Clinical Comparison of Narafilcon A and Stenfilcon A Contact Lenses

NCT02920970 | Completed Results

• 1 other identifier: EX-MKTG-71 (C16-601)
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the clinical performance and subjective acceptance of the narafilcon A lens with the stenfilcon A lens when used on a daily wear, daily disposable basis.

Conditions

Myopia

Outcome Measures

Primary Outcomes (11)

• Ocular Physiology

  Ocular physiology assessment of narafilcon A and stenfilcon A lenses by biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).

  1 week

• Visual Acuity

  Visual acuity for narafilcon A and stenfilcon A are assessed by LogMAR. High contrast is measured with black letters on a white background. Low contrast is measured with gray letters on a white background.

  1 week

• Comfort Level of Stenfilcon A and Narafilcon A Lenses

  Subjective responses for overall comfort will be evaluated for each pair using questionnaire (Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).

  1 week

• Dryness of Stenfilcon A and Narafilcon A Lenses

  Subjective responses for dryness will be evaluated for each pair using questionnaire (Scale 0-100, 0=extremely poor, high levels of dryness, 100=excellent, no dryness).

  1 week

• Vision of Stenfilcon A and Narafilcon A Lenses

  Subjective responses for vision will be evaluated for each pair using questionnaire (Scale 0-100, 0=unacceptable, lens cannot be worn, 100=excellent).

  1 week

• Lens Surface - Deposition on Stenfilcon A and Narafilcon A Lenses

  Lens surface for narafilcon A and stenfilcon A is assessed. (Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe)

  1 week

• Lens Surface - Wettability of Stenfilcon A and Narafilcon A Lenses

  Lens wettability for narafilcon A and stenfilcon A is assessed. (Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe)

  1 week

• Lens Fit - Horizontal Centration of Stenfilcon A and Narafilcon A Lenses

  Horizontal centration assessed for narafilcon A and stenfilcon A lenses categorized as extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal.

  1 week

• Lens Fit - Vertical Centration of Stenfilcon A and Narafilcon A Lenses

  Vertical centration assessed for narafilcon A and stenfilcon A lenses and graded as extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal.

  1 week

• Lens Fit - Corneal Coverage of Stenfilcon A and Narafilcon A Lenses

  Corneal coverage will be assessed for narafilcon A and stenfilcon A and categorized as extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.

  1 week

• Lens Movement

  Lens movement assessed for narafilcon A and senofilcon A lenses and categorized as extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.

  1 week

Study Arms (2)

narafilcon A

ACTIVE COMPARATOR

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

Device: narafilcon A

stenfilcon A

ACTIVE COMPARATOR

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

Device: stenfilcon A

Interventions

narafilcon A DEVICE

contact lens

narafilcon A

stenfilcon A DEVICE

contact lens

stenfilcon A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects will only be eligible for the study if:
• They are of legal age (18) and capacity to volunteer.
• 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 have a contact lens spherical prescription between -1.00 to - 6.00D (Diopters) (inclusive)
• They have a spectacle cylindrical correction of -0.75D or less in each eye.
• They can be satisfactorily fitted with the study lens types.
• At dispensing, they can attain at least 0.10 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.
• They currently use soft contact lenses or have done so in the previous six months.
• They are willing to comply with the wear schedule (at least six days per week and for at least eight hours per day).
• They own a wearable pair of spectacles.

You may not qualify if:

• Subjects will not be eligible to take part in the study if:
• They have an ocular disorder which would normally contra-indicate contact lens wear.
• They have a systemic disorder which would normally contra-indicate 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 breast-feeding.
• 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, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.
• They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
• They currently wear either the stenfilcon A lens or narafilcon A lens.

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: Sr. Manager Global Medical Scientific Affairs
• Organization: CooperVision Inc.

javega@coopervision.com

925-621-3761

Study Officials

• Philip Morgan, PhD, FAAO, FBCLA

  Eurolens Research, University of Manchester

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• 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: September 29, 2016
• First Posted: September 30, 2016
• Study Start: September 1, 2016
• Primary Completion: December 22, 2016
• Study Completion: May 31, 2017
• Last Updated: January 16, 2019
• Results First Posted: January 16, 2019

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)