The Clinical Comparison of Narafilcon A and Stenfilcon A Contact Lenses

Myopia Clinical Trial

Official title:

The Clinical Comparison of Narafilcon A and Stenfilcon A Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02920970
• Other study ID #: EX-MKTG-71 (C16-601)
• Status: Completed
• Phase: N/A
• Start date: September 1, 2016
• Est. completion date: May 31, 2017

Study information

• Verified date: July 2018
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: May 31, 2017
• Est. primary completion date: December 22, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• narafilcon A
contact lens
• stenfilcon A
contact lens

Locations

Country	Name	City	State
United Kingdom	Eurolens Research - The University of Manchester	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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