Performance of Fanfilcon A Toric Lenses After at Least One Month Wearing Enfilcon A Toric Lenses

NCT02921412 | Completed Results

• 1 other identifier: EX-MKTG-67
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 4

Brief Summary

This is a prospective, multi-center, subject-masked, bilateral, daily wear, two-month dispensing study

Conditions

Astigmatism

Outcome Measures

Primary Outcomes (5)

• Visual Acuity

  High contrast distance visual acuity is measured by LogMAR.

  baseline, 2 weeks, 1 month

• Centration

  Lens centration is assessed (optimum, decentration acceptable, decentration unacceptable).

  baseline, 2 weeks, 1 month

• Corneal Coverage

  Corneal coverage will be assessed (yes/no)

  baseline, 2 weeks, 1 month

• Post-blink Movement

  Post-blink lens movement assessed using the following evaluations (0-4): 0=Insufficient, unacceptable, 1=Minimal, acceptable, 2=Optimal, 3=Moderate, acceptable, 4=Excessive, unacceptable)

  baseline, 2 weeks, 1 month

• Fit Acceptability

  Investigator fit acceptability for each lens pair. Scale 0-4: (0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect)

  baseline, 2 weeks, 1 month

Study Arms (2)

enfilcon A (habitual)

NO INTERVENTION

All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses.

fanfilcon A

ACTIVE COMPARATOR

All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses.

Device: fanfilcon A

Interventions

fanfilcon A DEVICE

contact lens

fanfilcon A

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Is between 18 and 40 years of age (inclusive)
• Has had a self-reported eye exam in the last two years
• Is a habitual soft toric lens wearer
• Can be successfully fit with study lenses (≥ grade 2 fit acceptance)
• Has a contact lens spherical prescription between -1.00 to -6.00D with a cylinder between -0.75 and -1.75D (Diopters) (inclusive)
• Has a spectacle cylinder of at least 0.75D in each eye.
• Can achieve best corrected spectacle refraction distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
• Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
• Has clear corneas and no active ocular disease
• Has read, understood and signed the information consent letter
• Has a contact lens refraction that fits within the available parameters of the study lenses
• Is willing to comply with the wear schedule (at least 5 days per week, \> 8 hours/day assuming there are no contraindications for doing so)
• Is willing to comply with the visit schedule.

You may not qualify if:

• A person will be excluded from the study if he/she:
• Has a history of not achieving comfortable CL (Contact Lens) wear (5 days per week; \> 8 hours/day)
• Presents with clinically significant anterior segment abnormalities
• Presents with ocular or systemic disease or need of medications which might interfere with contact lens wear
• Presents with slit lamp findings that would contraindicate contact lens wear such as:
• Pathological dry eye or associated findings
• Significant pterygium, pinguecula, or corneal scars within the visual axis
• Neovascularization \> 0.75 mm in from of the limbus
• Anterior uveitis or iritis (or history in past year)
• Seborrheic eczema of eyelid region, Seborrheic conjunctivitis
• History of corneal ulcers or fungal infections
• Poor personal hygiene
• Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
• Has aphakia, keratoconus or a highly irregular cornea.
• Has presbyopia or has dependence on spectacles for near work over the contact lenses.

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (4)

Hospital Contact Lens Service

Miami, Florida, 33136, United States

Location

Debbie Kim

Closter, New Jersey, 07624, United States

Location

West Village Eyecare

New York, New York, 10014, United States

Location

Spokane Eye Clinic

Spokane, Washington, 99204, United States

Location

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

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

JVega2@coopervision.com

9256213761

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: September 29, 2016
• First Posted: October 3, 2016
• Study Start: October 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: March 21, 2017
• Last Updated: April 10, 2018
• Results First Posted: March 13, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)