A Clinical Comparison of Two Daily Disposable Soft Contact Lenses

NCT04005885 | Completed Results FDA Device

• 1 other identifier: EX-MKTG-100
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

This double-masked, randomized, bilateral, crossover, direct refit study compared the clinical performance of two daily disposable contact lenses (somofilcon A and stenfilcon A) when fitted to existing wearers of comfilcon A monthly lenses.

Conditions

Myopia

Outcome Measures

Primary Outcomes (2)

• Subjective Scores of Comfort at Insertion After 4 Weeks of Comfilcon A Use

  Subjective Scores of comfort at Insertion after 4 weeks of Comfilcon A use rated on a scale 0-100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).

  4 weeks

• Subjective Scores of Comfort on Insertion

  Subjective Scores of Comfort on Insertion rated on a scale 0 -100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).

  1 week

Secondary Outcomes (19)

• Subjective Scores on Overall Comfort After 4 Weeks of Comfilcon Use

  4 weeks

• Subjective Scores on Overall Comfort

  1 week

• Subjective Scores on Comfort Before Removal After 4 Weeks of Comfilcon Use

  4 weeks

• Subjective Scores on Comfort Before Removal

  1 week

• Number of Participants With Horizontal Lens Centration Grade

  Baseline (after 5 minutes of lens dispense)

Study Arms (2)

somofilcon A then stenfilcon A contact lens

EXPERIMENTAL

Participants were fitted with comfilcon A lens on a daily wear, reusable basis for 1 month, then randomized to wear somofilcon A daily disposable test lens for 1 week of daily wear and stenfilcon A daily disposable test lens for 1 week of daily wear.

Device: comfilcon A; Device: somofilcon A; Device: stenfilcon A

stenfilcon A then somofilcon A contact lens

EXPERIMENTAL

Participants were fitted with comfilcon A lens on a daily wear, reusable basis for 1 month, then randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear and somofilcon A daily disposable test lens for 1 week of daily wear.

Device: comfilcon A; Device: somofilcon A; Device: stenfilcon A

Interventions

comfilcon A DEVICE

Contact Lens

Also known as: Control Lens

somofilcon A then stenfilcon A contact lens; stenfilcon A then somofilcon A contact lens

somofilcon A DEVICE

daily disposable contact lens

Also known as: somofilcon A daily disposable test lens, Test lens 1

somofilcon A then stenfilcon A contact lens; stenfilcon A then somofilcon A contact lens

stenfilcon A DEVICE

daily disposable contact lens

Also known as: stenfilcon A daily disposable test lens, Test lens 2

somofilcon A then stenfilcon A contact lens; stenfilcon A then somofilcon A contact lens

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects will only be eligible for the study if:
• They are between 18 and 40 years of age (inclusive).
• 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 are an existing soft reusable spherical contact lens wearer in both eyes.
• They have a contact lens spherical prescription between -0.50 to -6.00D (inclusive) based on the ocular refraction.
• They have a cylindrical correction of -0.875DC or less in each eye based on the ocular refraction
• They own a wearable pair of spectacles and wear them on the day of the initial visit.
• They have distance high contrast logMAR visual acuity of 0.2 or better in each eye with their habitual spectacles.
• They agree not to participate in other clinical research for the duration of the study.

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 are aphakic.
• 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 breastfeeding.
• 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.

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

javega@coopervision.com

925 621 3761

Study Officials

• Carole Maldonado-Codina, PhD, MCOptom, FAAO, FBCLA

  Eurolens Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Subjects and investigators will be masked to the study lenses - lenses will be overlabelled.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: July 2, 2019
• Study Start: March 1, 2019
• Primary Completion: November 8, 2019
• Study Completion: November 30, 2019
• Last Updated: January 5, 2021
• Results First Posted: December 11, 2020

Record last verified: 2020-12

Locations

GB (1)