Trial record 12 of 132 for:    ASTIGMATISM

Clinical Performance of Biofinity Toric Versus Air Optix for Astigmatism

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.
ClinicalTrials.gov Identifier:
NCT01965288
First received: October 11, 2013
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

The aim of this study is to compare the clinical performance of the Biofinity Toric (comfilcon A) contact lens, versus Air Optix for Astigmatism (lotrafilcon B) over 1 month of daily wear.


Condition Intervention Phase
Astigmatism
Device: comfilcon A
Device: lotrafilcon B
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Single-Center Study Comparing the Clinical Performance of Biofinity Toric Versus Air Optix for Astigmatism Over 1 Month of Daily Wear.

Further study details as provided by Coopervision, Inc.:

Primary Outcome Measures:
  • Subjective Assessment: Change in Comfort, dryness, handling and lens fit. [ Time Frame: Change from baseline over 8-weeks ] [ Designated as safety issue: No ]

    Subjective Assessment: Assessed by subject on a Visual Analog Scale from 0 -10.

    • Comfort: (10=can't feel)
    • Dryness: (10=no dryness)
    • Handling: (10=very easy)
    • Fit: (10=very stable)


Secondary Outcome Measures:
  • Subjective Assessment: Change in Vision [ Time Frame: Change from baseline over 8-weeks ] [ Designated as safety issue: No ]
    Subjective Assessment: Assessed by subject on a Visual Analog Scale fro 0-10. Vision (10=very satisfied)

  • Objective Practitioner Measurements: Ocular response [ Time Frame: Visits: V1 (baseline), V2 (2 weeks), V3 (4 weeks) V4 (6-weeks) V5 (8-weeks) ] [ Designated as safety issue: No ]

    Objective Practitioner Measurements (Biomicroscopy): Ocular response assessed using slit lamp with white light, low-medium magnification.

    (Brien Holden Vision Institute grading scales for reference, ½ grades recorded.)

    • 0 NONE
    • 1 VERY SLIGHT
    • 2 SLIGHT
    • 3 MODERATE
    • 4 SEVERE


Enrollment: 60
Study Start Date: September 2013
Study Completion Date: May 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: comfilcon A
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating the schedule for the second pair without a washout period.
Device: comfilcon A
test lens Pair(comfilcon A) or the control lens Pair(lotrafilcon B)
Other Name: Biofinity Toric
Device: lotrafilcon B
test lens Pair(comfilcon A) or the control lens Pair(lotrafilcon B)
Other Name: Air Optix
Active Comparator: lotrafilcon B
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating the schedule for the second pair without a washout period.
Device: comfilcon A
test lens Pair(comfilcon A) or the control lens Pair(lotrafilcon B)
Other Name: Biofinity Toric
Device: lotrafilcon B
test lens Pair(comfilcon A) or the control lens Pair(lotrafilcon B)
Other Name: Air Optix

Detailed Description:

Single masked, open label, randomized, bilateral, crossover study design comparing comfilcon A against lotrafilcon B lenses over 1 month of daily wear for each study lens. Each subject will be randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating the schedule for the second pair without a washout period.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

  • Is between 18 and 40 years of age (inclusive)
  • Has had a self-reported visual exam in the last two years
  • Is an adapted soft toric contact lens wearer
  • Has a contact lens spherical prescription between +6.00 to - 10.00 (inclusive)
  • Have no less than 0.75D of astigmatism and no more than 2.25D in both eyes.
  • Can achieve best corrected spectacle 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.
  • Patient contact lens refraction should fit 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

Exclusion Criteria:

A person will be excluded from the study if he/she:

  • Has a CL prescription outside the range of the available parameters of the study lenses.
  • Has a spectacle cylinder less than -0.75D or more than -2.25 D of cylinder in either eye.
  • Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
  • Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.
  • Presence of clinically significant (grade 2-4) anterior segment abnormalities
  • Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.
  • Slit lamp findings that would contraindicate contact lens wear such as:

    • Pathological dry eye or associated findings
    • Pterygium, pinguecula, or corneal scars within the visual axis
    • Neovascularization > 0.75 mm in from of the limbus
    • Giant papillary conjunctivitis (GCP) worse than grade 1
    • Anterior uveitis or iritis (past or present)
    • Seborrheic eczema, 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.
  • Has undergone corneal refractive surgery.
  • Is participating in any other type of eye related clinical or research study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01965288

Locations
Spain
Optometry Research Group (GIO) - Optics Department, University of Valencia
Valencia, Spain
Sponsors and Collaborators
Coopervision, Inc.
Investigators
Principal Investigator: Robert Montés-Mico, OD MPhil PhD Optometry Research Group (GIO) - Optics Department, University of Valencia
  More Information

No publications provided

Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT01965288     History of Changes
Other Study ID Numbers: EX-MKTG-42
Study First Received: October 11, 2013
Last Updated: July 15, 2014
Health Authority: Spain: Ethics Committee

Additional relevant MeSH terms:
Astigmatism
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on July 24, 2014