A Clinical Comparison of 2 Multifocal Toric XR (Extended Range) Contact Lenses

NCT03006458 | Completed Results FDA Device

• 1 other identifier: CV-16-28 (C16-599)
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the clinical performance and subjective acceptance of the comfilcon A and the omafilcon B soft contact lenses.

Conditions

Astigmatism

Outcome Measures

Primary Outcomes (17)

• Stability

  Investigator's acceptance on overall stability for comfilcon A and omafilcon B lenses assessed using grading scale 0-4, 0=Totally unstable, can't be worn to provide acceptable vision correction for astigmatism, 4=Excellent orientation and optimum rotational.

  Baseline

• Stability

  Investigator's acceptance on overall stability for comfilcon A and omafilcon B lenses assessed using grading scale 0-4, 0=Totally unstable, can't be worn to provide acceptable vision correction for astigmatism, 4=Excellent orientation and optimum rotational.

  2 weeks

• Overall Toric Lens Fit Acceptance

  Overall toric lens fit acceptance is assessed for comfilcon A and omafilcon B lenses. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.

  Baseline

• Overall Toric Lens Fit Acceptance

  Overall toric lens fit acceptance is assessed for comfilcon A and omafilcon B lenses. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.

  2 weeks

• Comfort

  Subjective ratings for comfort assessed. Scale 0-100, 0=cannot be worn, causes pain; 100=cannot be felt ever

  Baseline

• Comfort

  Subjective ratings for comfort assessed. Scale 0-100, 0=cannot be worn, causes pain; 100=cannot be felt ever

  2 weeks

• Overall Satisfaction

  Subjective ratings for overall satisfaction for comfilcon A and omafilcon B lenses assessed. Scale 0-100, 0=extremely dissatisfied, 100=extremely satisfied

  2 weeks

• Dryness

  Subjective ratings for dryness assessed. Scale 0-100, 0=cannot be worn, extremely dry; 100=no dryness experienced at any time

  2 weeks

• Visual Fluctuation/ Stability

  Subjective ratings for visual fluctuation/stability assessed. Scale 0-100, 0=totally unstable/ fluctuation/changing; 100=perfectly stable/not fluctuation/changing

  2 weeks

• Handling

  Subjective ratings for handling difficulty assessed at 2 weeks. Scale 0-100, 0=very difficult, 100=very easy

  2 weeks

• Quality of Near Vision

  Subjective ratings for quality of near vision. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.

  2 weeks

• Quality of Intermediate Vision

  Subjective ratings for quality of intermediate vision. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.

  2 weeks

• Quality of Distance Vision

  Subjective ratings for quality of distance vision. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.

  2 weeks

• Quality of Vision While Driving During the Day

  Subjective rating for quality of vision while driving during the day. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.

  2 weeks

• Quality of Vision While Driving During the Night

  Subjective ratings for quality of vision while driving at night. Scale 0-100, 0=extremely poor vision all of the time. cannot function, 100 - excellent vision all of the time.

  2 weeks

• Ghosting at Near

  Subjective ratings for ghosting at near assessed at 2 weeks. Scale 0-100, 0=intolerable, 100=not noticeable.

  2 weeks

• Ghosting at Distance

  Subjective ratings for ghosting at distance assessed at 2 weeks. Scale 0-100, 0=intolerable, 100=not noticeable.

  2 weeks

Study Arms (2)

comfilcon A

EXPERIMENTAL

Participants were randomized to wear comfilcon A toric lenses for two weeks during the cross over study. The final optical design of comfilcon A contact lens was optimized to improve the quality and two further studies (CV-18-10 and CV-18-11) were conducted after completion of this study to evaluate the modified optical design.

Device: comfilcon A

omafilcon B

ACTIVE COMPARATOR

Participants were randomized to wear omafilcon B toric lenses for two weeks during the cross over study.

Device: omafilcon B

Interventions

comfilcon A DEVICE

toric contact lens

comfilcon A

omafilcon B DEVICE

toric contact lens

omafilcon B

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects will only be eligible for the study if:
• They are aged 40 - 70 years, 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 have successfully completed the non-dispensing study (C16-597) as the lenses to be worn on this study (C16-599) are predetermined from their participation on study C16-597.
• They have a contact lens spherical prescription between +10.00 to -10.00D (Diopters) (inclusive).
• They have astigmatism between of -0.75 and -5.75DC (based on the calculated ocular refraction) in each eye.
• They have an Add component to their spectacle refraction (between +0.75 and
• +2.50DS).
• They can be satisfactorily fitted with the study lenses.
• They can attain at least 0.30 logMAR binocular distance high contrast visual acuity with the study lenses within the available power range.
• They have successfully worn soft contact lenses in the last two years.
• They are willing to comply with the wear schedule (at least five days per week and for at least six hours per day).
• They agree not to participate in other clinical research for the duration of this study.
• They own a wearable pair of spectacles.

You may not qualify if:

• Subjects will not be eligible to take part in the study 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 clinically meaningful slit lamp findings contraindicating contact lens wear (e.g. ≥ Grade 3 finding of oedema, corneal neovascularisation, corneal staining, tarsal abnormalities, conjunctival injection, blepharitis/meibomian gland dysfunction) on the Efron classification scale or any other ocular abnormality that in the opinion of the investigator would contraindicate contact lens wear.
• They have any infectious disease (e.g. hepatitis) 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).
• They have 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

Manchester, M13 9PL, United Kingdom

Location

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Myhanh Nguyen
• Organization: CooperVision

MNguyen@coopervision.com

9257306716

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: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2016
• First Posted: December 30, 2016
• Study Start: December 1, 2016
• Primary Completion: April 6, 2017
• Study Completion: April 6, 2017
• Last Updated: June 1, 2020
• Results First Posted: June 1, 2020

Record last verified: 2020-05

Locations

GB (1)