The Clinical Comparison of Narafilcon A and Stenfilcon A Contact Lenses

• ClinicalTrials.gov Identifier: NCT02920970
• Recruitment Status: Completed
• First Posted: September 30, 2016
• Results First Posted: January 16, 2019
• Last Update Posted: January 16, 2019
• Sponsor: Coopervision, Inc.
• Information provided by (Responsible Party): Coopervision, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Myopia	Device: narafilcon A; Device: stenfilcon A	Not Applicable

Detailed Description:

This will be a randomized, subject-masked, crossover, bilateral study, controlled by cross comparison. Seventy subjects will use each lens type for a week in a random sequence. Follow-up visits for each lens will be performed after one week of wear. Lenses will be worn on a daily wear, daily disposable wear schedule.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: The Clinical Comparison of Narafilcon A and Stenfilcon A Contact Lenses
• Actual Study Start Date: September 1, 2016
• Actual Primary Completion Date: December 22, 2016
• Actual Study Completion Date: May 31, 2017

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: narafilcon A; Participants are randomized to wear narafilcon A lens pair for one week during the cross over study.	Device: narafilcon A; contact lens
Active Comparator: stenfilcon A; Participants are randomized to wear stenfilcon A lens pair for one week during the cross over study.	Device: stenfilcon A; contact lens

Outcome Measures

Primary Outcome Measures :

1. Ocular Physiology [ Time Frame: 1 week ]
   Ocular physiology assessment of narafilcon A and stenfilcon A lenses by biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
2. Visual Acuity [ Time Frame: 1 week ]
   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.
3. Comfort Level of Stenfilcon A and Narafilcon A Lenses [ Time Frame: 1 week ]
   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).
4. Dryness of Stenfilcon A and Narafilcon A Lenses [ Time Frame: 1 week ]
   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).
5. Vision of Stenfilcon A and Narafilcon A Lenses [ Time Frame: 1 week ]
   Subjective responses for vision will be evaluated for each pair using questionnaire (Scale 0-100, 0=unacceptable, lens cannot be worn, 100=excellent).
6. Lens Surface - Deposition on Stenfilcon A and Narafilcon A Lenses [ Time Frame: 1 week ]
   Lens surface for narafilcon A and stenfilcon A is assessed. (Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe)
7. Lens Surface - Wettability of Stenfilcon A and Narafilcon A Lenses [ Time Frame: 1 week ]
   Lens wettability for narafilcon A and stenfilcon A is assessed. (Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe)
8. Lens Fit - Horizontal Centration of Stenfilcon A and Narafilcon A Lenses [ Time Frame: 1 week ]
   Horizontal centration assessed for narafilcon A and stenfilcon A lenses categorized as extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal.
9. Lens Fit - Vertical Centration of Stenfilcon A and Narafilcon A Lenses [ Time Frame: 1 week ]
   Vertical centration assessed for narafilcon A and stenfilcon A lenses and graded as extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal.
10. Lens Fit - Corneal Coverage of Stenfilcon A and Narafilcon A Lenses [ Time Frame: 1 week ]
    Corneal coverage will be assessed for narafilcon A and stenfilcon A and categorized as extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.
11. Lens Movement [ Time Frame: 1 week ]
    Lens movement assessed for narafilcon A and senofilcon A lenses and categorized as extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Subjects will only be eligible for the study if:

  1. They are of legal age (18) and capacity to volunteer.
  2. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
  3. They are willing and able to follow the protocol.
  4. They agree not to participate in other clinical research for the duration of this study.
  5. They have a contact lens spherical prescription between -1.00 to - 6.00D (Diopters) (inclusive)
  6. They have a spectacle cylindrical correction of -0.75D or less in each eye.
  7. They can be satisfactorily fitted with the study lens types.
  8. 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.
  9. They currently use soft contact lenses or have done so in the previous six months.
  10. They are willing to comply with the wear schedule (at least six days per week and for at least eight hours per day).
  11. They own a wearable pair of spectacles.

Exclusion Criteria:

• Subjects will not be eligible to take part in the study if:

  1. They have an ocular disorder which would normally contra-indicate contact lens wear.
  2. They have a systemic disorder which would normally contra-indicate contact lens wear.
  3. They are using any topical medication such as eye drops or ointment.
  4. They have had cataract surgery.
  5. They have had corneal refractive surgery.
  6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
  7. They are pregnant or breast-feeding.
  8. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
  9. 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.
  10. They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
  11. They currently wear either the stenfilcon A lens or narafilcon A lens.

Contacts and Locations

Locations

United Kingdom

Eurolens Research - The University of Manchester

Manchester, United Kingdom, M13 9PL

Sponsors and Collaborators

Coopervision, Inc.

Investigators

• Study Director: Philip Morgan, PhD, FAAO, FBCLA; Eurolens Research, University of Manchester

More Information

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT02920970
• Other Study ID Numbers: EX-MKTG-71 (C16-601)
• First Posted: September 30, 2016
• Results First Posted: January 16, 2019
• Last Update Posted: January 16, 2019
• Last Verified: July 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Myopia; Refractive Errors; Eye Diseases