Multicenter Dispensing Study of Biofinity Toric Made-To-Order Lenses in Extended Power Ranges

NCT02193178 | Completed Results

• 1 other identifier: CV-14-05
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

The study hypothesis is that the Biofinity Toric XR lenses will perform as well as or better than the participants' habitual contact lenses.

Conditions

Myopia; Astigmatism

Outcome Measures

Primary Outcomes (17)

• Overall Comfort

  Subjective ratings for overall comfort for habitual lenses assessed 2 weeks prior to baseline and for comfilcon A lenses assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=cannot be worn, causes pain, and 100=cannot be felt ever.

  2 weeks prior to baseline, Baseline, 2 weeks post baseline

• Overall Vision

  Subjective ratings for overall vision for habitual lenses assessed 2 weeks prior to baseline and vision for comfilcon A assessed at baseline and 2 weeks post.Scale 0-100, 0=Extremely poor vision all of the time, cannot function, 100=Excellent vision all of the time.

  2 weeks prior to baseline, Baseline, 2 weeks post

• Handling

  Subjective ratings for handling for habitual lenses assessed 2 weeks prior to baseline and handling for comfilcon A assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=Very difficult, 100=Very easy

  2 weeks prior to baseline, Baseline, 2 weeks post baseline

• Overall Satisfaction

  Subjective ratings for overall satisfaction for habitual lenses assessed 2 weeks prior to baseline and overall satisfaction for comfilcon A assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=Extremely dissatisfied, 100=Extremely satisfied.

  2 weeks prior to baseline, Baseline, 2 weeks post baseline

• Lens Fit - Rotation

  Lens Fit (rotation) for habitual lenses were assessed 2 weeks prior to baseline and then refitted with comfilcon A lenses. After refitting with comfilcon A, lens fit rotation was assessed at baseline and 2 weeks. Lens rotation was measured within 10 degrees of the desired 6 o'clock position. Scale 0-180 degrees, 0=no rotation, 180=max rotation.

  2 weeks prior to baseline, Baseline, 2 weeks post baseline

• Lens Fit - Overall Stability

  Lens Fit (stability) for habitual lenses assessed 2 weeks prior to baseline and then refitted with comfilcon A lenses. After refitting with comfilcon A lenses, stability was assessed at baseline and 2 weeks. Scale 0-4, 0=Totally unstable, can't be worn to provide acceptable vision correction for an astigmatism, 4=Excellent orientation and optimum rotational recovery and stability

  2 weeks prior to baseline, Baseline, 2 weeks post baseline

• Lens Fit Acceptance

  General lens fit acceptance for habitual lenses assessed 2 weeks prior to baseline and refitted with comfilcon A lenses, which were assessed at baseline and at 2 weeks. (Scale 0-4, 0=Can't be worn; 4=Optimum)

  2 weeks prior to baseline, Baseline, 2 weeks post baseline

• Anterior Ocular Health - Palpebral Hyperemia and Roughness

  Palpebral hyperemia and roughness for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=None, 4=Severe

  Baseline and 2 weeks

• Anterior Ocular Health - Bulbar and Limbal Redness

  Bulbar and limbal redness for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=None; 4=Severe injection

  Baseline and 2 weeks

• Anterior Ocular Health - Corneal Staining

  Corneal staining for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=No staining; 4= \>45% of area

  Baseline and 2 weeks

• Anterior Ocular Health - Conjunctival Staining and Indentation

  Conjunctival staining and indentation for comfilcon A lenses assessed at baseline and 2 weeks. Conjuctival staining scale 0-4, 0=None, 4=Severe

  Baseline and 2 weeks

• Visual Acuity

  Visual acuity for habitual lenses assessed 2 weeks prior to baseline and for comfilcon A assessed at baseline and 2 weeks post baseline using logMAR.

  2 weeks prior to baseline, Baseline, 2 weeks post baseline

• Subjective Preference - Comfort

  Subjective preference for comfort between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses

  Baseline and 2 weeks

• Preference - Vision

  Subjective preference for vision between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses

  Baseline and 2 weeks

• Preference - Handling

  Subjective preference for handling between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses

  Baseline and 2 weeks

• Overall Preference

  Overall subjective preference between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses

  Baseline and 2 weeks

• Investigator Acceptability

  Investigator's preference on acceptability of refitting subjects in to comfilcon A lens based on lens performance assessed at baseline and 2 weeks.Scale 1-5, 1=Strongly agree, 5=Strongly disagree.

  Baseline and 2 weeks

Study Arms (1)

comfilcon A toric

EXPERIMENTAL

Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.

Device: comfilcon A Toric

Interventions

comfilcon A Toric DEVICE

Contact lenses

Also known as: Biofinity

comfilcon A toric

Eligibility Criteria

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

You may qualify if:

• Has had an oculo-visual examination in the last two years
• Is at least 18 years of age and has full legal capacity to volunteer
• Has read and understood the information consent letter
• Is willing and able to follow instructions and maintain the appointment schedule
• Is correctable to a visual acuity of 20/50 or better (in at least one eye)
• Currently wears soft toric contact lenses in both eyes
• Subject contact lens prescription must fall under one of the contact lens power ranges for at least one eye:
• D to -10.50D spherical powers and cylinder powers from - 0.75 to -2.25
• +8.50D to +20.00D spherical powers and cylinder powers from - 0.75 to -2.25
• D to -6.50D spherical powers and cylinder powers from -2.75 to -5.75
• D to +6.00D spherical powers and cylinder powers from -2.75 to -5.75
• +6.50D to +20.00D spherical powers and cylinder powers from-2.75 to -5.75
• Has clear corneas and no active ocular disease
• Demonstrates an acceptable fit with the study lenses

You may not qualify if:

• Has never worn contact lenses before;
• Has any systemic disease affecting ocular health;
• Is using any systemic or topical medications that will affect ocular health;
• Has any ocular pathology or abnormality that would affect the wearing of contact lenses;
• Has undergone corneal refractive surgery;
• Is participating in any other type of eye related clinical or research study.

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (2)

Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University

Bloomington, Indiana, 47405, United States

Location

Texas Eye Research and Technology Center (TERTC) College of Optometry, University of Houston

Houston, Texas, 77204, United States

Location

MeSH Terms

Conditions

Myopia; Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Sr. Manager, Clinical Research
• Organization: CooperVision, Inc.

pchamberlain@coopervision.com

9257306754

Study Officials

• Jan Bergmanson, OD PhD

  Texas Eye Research and Technology Center (TERTC), School of Optometry, University of Houston

  PRINCIPAL INVESTIGATOR

• Pete Kollbaum, OD PhD

  Clinical Optics Research Lab (CORL), Indiana University School of Optometry, Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2014
• First Posted: July 17, 2014
• Study Start: July 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: July 29, 2020
• Results First Posted: February 17, 2017

Record last verified: 2020-07

Locations

US (2)