The Clinical Comparison of Narafilcon A and Stenfilcon A Contact Lenses

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: stenfilcon A; Device: narafilcon A

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 Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M13 9PL
    • Eurolens Research - The University of Manchester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Coopervision, Inc.
• Investigators: Study Director: Philip Morgan, PhD, FAAO, FBCLA, Eurolens Research, University of Manchester

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2016
• Primary Completion (ACTUAL): December 22, 2016
• Study Completion (ACTUAL): May 31, 2017

Study Registration Dates

• First Submitted: September 29, 2016
• First Submitted That Met QC Criteria: September 29, 2016
• First Posted (ESTIMATE): September 30, 2016

Study Record Updates

• Last Update Posted (ACTUAL): January 16, 2019
• Last Update Submitted That Met QC Criteria: July 26, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: EX-MKTG-71 (C16-601)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO