The Clinical Comparison of Somofilcon A 1 Day and Nelfilcon A Daily Disposable Contact Lenses

NCT04067141 | Completed Results FDA Device

• 1 other identifier: EX-MKTG-75
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This subject-masked, randomized, bilateral crossover study will compare the clinical performance and subjective acceptance of the somofilcon A 1 day soft contact lens with the nelfilcon A daily disposable lens when used on a daily wear, daily disposable basis.

Conditions

Ametropia

Outcome Measures

Primary Outcomes (7)

• Subjective Comfort at Lens Dispensing

  Subjective comfort at lens dispensing on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).

  Baseline (after 5 minutes of lens dispense)

• Subjective Comfort at Start of Day

  Subjective comfort at start of day on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).

  1 week

• Subjective Comfort at End of Day

  Subjective comfort at end of day on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).

  1 week

• Overall Subjective Comfort

  Overall subjective comfort on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).

  Baseline (after 5 minutes of lens dispense)

• Overall Subjective Comfort

  Overall subjective comfort on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).

  1 week

• Subjective Vision

  Subjective Vision rated on scale 0-100 (0=unacceptable, lens cannot be worn to 100=excellent, unaware of an visual loss.)

  Baseline (after 5 minutes of lens dispense)

• Subjective Vision

  Subjective Vision rated on scale 0-100 (0=unacceptable, lens cannot be worn to 100=excellent, unaware of an visual loss.)

  1 week

Secondary Outcomes (14)

• Biomicroscopy - Conjunctival Redness Score

  One Week

• Biomicroscopy - Limbal Redness Score

  One week

• Biomicroscopy - Corneal Staining Score

  One week

• Biomicroscopy - Conjunctival Staining Score

  One week

• Biomicroscopy - Papillary Conjunctivitis Score

  One week

Study Arms (2)

somofilcon A, then nelfilcon A

EXPERIMENTAL

Subjects will bilaterally wear the somofilcon A lenses, then crossover to nelfilcon A lenses after one week of wear. Both lenses will be worn on a daily wear basis for one week.

Device: somofilcon A; Device: nelfilcon A

nelfilcon A, then somofilcon A

EXPERIMENTAL

Subjects will bilaterally wear the nelfilcon A lenses, then crossover to somofilcon A lenses after one week of wear. Both lenses will be worn on a daily wear basis for one week.

Device: somofilcon A; Device: nelfilcon A

Interventions

somofilcon A DEVICE

Contact Lens

Also known as: somofilcon A 1 day, test lens, clariti 1 day

nelfilcon A, then somofilcon A; somofilcon A, then nelfilcon A

nelfilcon A DEVICE

Contact Lens

Also known as: nelfilcon A Daily Disposable Contact Lens, control lens, DAILIES AquaComfort PLUS daily disposable

nelfilcon A, then somofilcon A; somofilcon A, then nelfilcon A

Eligibility Criteria

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

You may qualify 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 (inclusive)
• They have a maximum of -1.00DC ocular astigmatism in each eye.
• They can be satisfactorily fitted with the study lens types.
• At dispensing, they can attain at least 0.20 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 five days per week and for at least eight hours per day).
• They own a wearable pair of spectacles.

You may not qualify 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 clariti 1day or the DAILIES AquaComfort Plus lens.

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

Eurolens Research

Manchester, M13 9PL, United Kingdom

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Jose A. Vega, O.D., MSC., FAAO
• Organization: CooperVision, Inc.

javega@coopervision.com

9256213761

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Model Details: This is a bilateral crossover study

Study Record Dates

• First Submitted: August 21, 2019
• First Posted: August 26, 2019
• Study Start: July 4, 2019
• Primary Completion: November 5, 2019
• Study Completion: November 20, 2019
• Last Updated: November 24, 2020
• Results First Posted: November 24, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)