Clinical Validation of Biofinity Toric MTO (Made To Order) Lenses

NCT02185105 | Completed Results

• 1 other identifier: CV-14-04
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The study hypothesis is there is no difference in the clinical performance between the test and control lenses, in particular in lens stability, toric mislocation, comfort ratings and anterior segment ocular health findings.

Conditions

Myopia; Astigmatism

Outcome Measures

Primary Outcomes (19)

• Lens Surface Assessment of Study Lenses - Surface Wettability

  Investigator's objective assessment of lens surface wettability at 15min and 6hrs. Scale (0-4; 0=non-wetting, 4=Excellent)

  15min & 6hrs

• Lens Surface Assessment of Study Lenses - Deposits

  Investigator's objective assessment of lens surface deposition at 15min and 6hrs. Graded on the appearance of lens surface by slit lamp. Rated on a scale (0-4; 0=no deposits, 4=deposits ≥0.5mm or film \> 75% of surface)

  15min & 6hrs

• Lens Surface Assessment of Study Lenses - Surface Acceptance

  Investigator's objective assessment of surface acceptance at 15min and 6hrs. Rated on a scale (0-4; 0=very poor, 4=excellent)

  15min & 6hrs

• Subjective Rating For Comfort - Comfort Since Last Visit

  Participant's subjective rating of comfort now of study lenses. Surveyed at 15min, 3hr, and 6hr. Scale (0-100; 0=cannot be worn, causes pain, 100=cannot be felt ever)

  15min, 3hrs, 6hrs

• Subjective Rating For Comfort Preference

  Participant's subjective rating of comfort preference of study lenses. Scale: (Strongly Prefer Right lens - Strongly Prefer Left Lens)

  1min, 15min, 3hrs, 6hrs

• Subjective Rating For Handling - Insertion

  Participant's subjective rating for ease of insertion of the study lenses. Scale (0-100; 0=could not place lens on eye;100=always easy to place lens on eye)

  1 min

• Subjective Rating For Handling - Removal

  Participant's subjective rating for ease of removal of study lenses. Scale (0-100; 0=could not remove lens from eye;100=always easy to place remove from eye)

  1 min

• Investigator's Assessment of Stability

  Investigator's assessment of the study lenses overall stability difference measured from 0-180 degrees, 0=very good stability, 180=very bad stability.

  15min & 6hrs

• General Lens Fit - Fit Acceptance

  Investigator's assessment for fit acceptance of study lenses. Scale: 0-4 (0=Should not be worn; 4=Perfect)

  15min & 6hrs

• Lens Fitting - Rotation/Mislocation

  Investigator's observed the rotation/mislocation (toric mark) of study lenses from the desired 6 o'clock position following temp rotation 30 degrees, 10 blinks; rotation toward desired 6 o'clock position=(+); rotation away from desired 6 o'clock position=(-).

  Baseline, 15min & 6hrs

• Anterior Ocular Health - Corneal Staining (Central)

  Corneal staining (central) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= \>45% of area)

  baseline & 6hrs

• Anterior Ocular Health - Corneal Staining (Nasal)

  Corneal staining (nasal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= \>45% of area)

  baseline & 6hrs

• Anterior Ocular Health - Corneal Staining (Temporal)

  Corneal staining (temporal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= \>45% of area)

  baseline & 6hrs

• Anterior Ocular Health - CornealStaining (Superior)

  Corneal staining (superior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= \>45% of area)

  baseline & 6hrs

• Anterior Ocular Health - Corneal Staining (Inferior)

  Corneal staining (inferior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= \>45% of area)

  baseline & 6hrs

• Anterior Ocular Health - Conjunctival Staining (Nasal)

  Conjunctival staining (nasal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).

  baseline & 6hrs

• Anterior Ocular Health - Conjunctival Staining (Superior)

  Conjunctival staining (superior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).

  baseline & 6hrs

• Anterior Ocular Health - Conjunctival Staining (Temporal)

  Conjunctival staining (temporal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).

  baseline & 6hrs

• Anterior Ocular Health - Conjunctival Staining (Inferior)

  Conjunctival staining (inferior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).

  baseline & 6hrs

Study Arms (2)

comfilcon A MTO

EXPERIMENTAL

Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.

Device: comfilcon A

comfilcon A

ACTIVE COMPARATOR

Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.

Device: comfilcon A MTO

Interventions

comfilcon A MTO DEVICE

Randomized to a test lens in one eye and control lens in the other as a matched pair.

Also known as: Biofinity Toric MTO

comfilcon A

comfilcon A DEVICE

Randomized to a test lens in one eye and control lens in the other as a matched pair.

Also known as: Biofinity Toric

comfilcon A MTO

Eligibility Criteria

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

You may qualify if:

• Has had a self-reported 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 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
• Currently wears soft contact lenses.
• Has clear corneas and no active ocular disease.
• Has not worn lenses for at least 12 hours before the examination

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 severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
• Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
• Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
• Is aphakic.
• 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 (1)

CORL, Indiana University

Bloomington, Indiana, 47405, 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

• Pete S Kollbaum, O.D.

  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: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2014
• First Posted: July 9, 2014
• Study Start: June 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: March 7, 2017
• Results First Posted: January 2, 2017

Record last verified: 2017-01

Locations

US (1)