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Clinical Evaluation of Two Toric Contact Lenses in Current Non-toric Lens Users

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01180998
First Posted: August 13, 2010
Last Update Posted: July 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Visioncare Research Ltd.
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.
  Purpose
The purpose of this study is to evaluate the clinical performance, defined as successful fit, of two toric contact lenses (one daily disposable and the other daily wear reusable contact lens to correct astigmatism) in current spherical soft contact lens wearers, contact lens drop-outs, and non-users of toric contact lenses (neophytes).

Condition Intervention
Astigmatism Device: Senofilcon A Toric (AOfA) Device: Etafilcon A Toric (1DAMfA)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Vision Care, Inc.:

Primary Outcome Measures:
  • Overall Success in Fitting With a Toric Contact Lens [ Time Frame: 4 weeks ]
    Percent of subjects with success with toric lens fitting defined as meeting all of the following pre-determined criteria: 1) acceptable fit, 2) orientation stability less than or equal to 20 degree rotation, 3) binocular visual acuity (VA) within one line of spectacle VA, 4) Good, very good, or excellent overall quality of Vision, and 5) good, very, good, or excellent overall lens comfort. There was not an inferential statistical analysis conducted on this outcome. Comparison was made through the use of 95% CI's for the proportions. Therefore no statistical analysis section is included for this primary outcome.

  • Distance Visual Acuity [ Time Frame: after 1 week of toric contact lens wear ]
    Measured monocularly (each eye separately) in Snellen converted to logMAR units. The logMAR scale has a range of -0.30 to 1.00. A value of 0 or less would not require distance vision correction and a value of 0 or greater may require distance vision correction.

  • Distance Visual Acuity (VA) [ Time Frame: after 4 weeks of toric contact lens wear ]
    Visual Acuity is measured monocularly (each eye separately) in Snellen, the converted to logMAR units. The logMAR scale has a range of -0.30 to 1.00. A value of 0 or less would not require distance vision correction and a value of 0 or greater may require distance vision correction.


Enrollment: 200
Actual Study Start Date: June 1, 2010
Study Completion Date: October 1, 2010
Primary Completion Date: October 1, 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Spherical contact lens users
Habitual spherical contact lens (non-toric lens) users tried one of two toric lenses in a daily wear modality.
Device: Senofilcon A Toric (AOfA)
Soft toric contact lenses for astigmatism
Device: Etafilcon A Toric (1DAMfA)
Soft toric contact lenses for astigmatism
Contact lens drop-outs
Habitual spectacle users (for vision correction) who have failed contact lens fit and wear, tried one of two toric lenses in a daily wear modality.
Device: Senofilcon A Toric (AOfA)
Soft toric contact lenses for astigmatism
Device: Etafilcon A Toric (1DAMfA)
Soft toric contact lenses for astigmatism
Habitual Correction with Spectacles (Neophytes)
Habitual spectacle lens wearers (for vision correction) who have never used or been fitted with contact lenses tried one of two toric lenses in a daily wear modality.
Device: Senofilcon A Toric (AOfA)
Soft toric contact lenses for astigmatism
Device: Etafilcon A Toric (1DAMfA)
Soft toric contact lenses for astigmatism

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Subjects must satisfy the following conditions prior to inclusion in the study:

  1. One of the following:

    1. Spherical contact lens user (minimum of 2 months wear, four days a week, 8 hours a day)
    2. Contact Lens drop-out (no contact lens wear in the last 6 months but wearing glasses at least four days a week,8 hours a day)
    3. Neophyte (no habitual contact lens wear except for trial fits up to 1 week, but wearing glasses at least four days a week,8 hours a day For patients not currently wearing lenses, patient should have expressed a desire to try lenses.
  2. Between 16 and 60 years of age.
  3. Have signed an informed consent form (documented by the investigator in the Case Report Form [CRF]).
  4. Distance requirement in the range of +4.00D to -9.00D (i.e. -10.00D refractive)
  5. Refractive astigmatism between -0.75D and -3.00D in both eyes.
  6. Have best corrected VA of 6/9 (20/30) or better in each eye.
  7. Have normal eyes with no evidence of abnormality or disease. For the purpose of this study a normal eye is defined as one having:

    1. No amblyopia.
    2. No evidence of lid abnormality or infection.
    3. No conjunctival abnormality or infection.
    4. No clinically significant slit lamp findings (i.e. stromal haze, staining, scarring, vascularisation, infiltrates or abnormal opacities).
    5. No other active ocular disease.
  8. Presbyopes may be included (no monovision, no spectacles over contact lenses or bifocal glasses only)

Exclusion Criteria:

Any of the following will render a subject ineligible for inclusion:

  1. Requires concurrent ocular medication.
  2. Clinically significant (Grade 3 or 4) corneal stromal haze, corneal vascularisation, tarsal abnormalities, bulbar hyperaemia, limbal hyperaemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
  3. Corneal staining Grade 3 in more than two regions.
  4. Extended wear in the last 3 months.
  5. Has had any anterior ocular surgery. Has had any other ocular surgery or injury within 8 weeks immediately prior to enrollment for this study.
  6. Abnormal lachrymal secretions.
  7. Pre-existing ocular irritation that would preclude contact lens fitting.
  8. Keratoconus or other corneal irregularity.
  9. Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
  10. Has diabetes.
  11. Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
  12. Pregnancy, lactating, or planning a pregnancy at the time of enrollment.
  13. Participation in any concurrent clinical trial or in last 60 days.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01180998


Locations
United Kingdom
Reading, Berkshire, United Kingdom
Marlow, Bucks, United Kingdom
Broadstone, Dorset, United Kingdom
Portchester, Hampshire, United Kingdom
Southsea, Hampshire, United Kingdom
St. Albans, Herts, United Kingdom
Shanklin, Isle of Wight, United Kingdom
Rawtenstall, Lancashire, United Kingdom
Hendon, London, United Kingdom
Pinner, Middlesex, United Kingdom
Teddington, Middlesex, United Kingdom
Uxbridge, Middlesex, United Kingdom
Cardiff, South Glamorgan, United Kingdom
Croydon, Surrey, United Kingdom
Coventry, West Midlands, United Kingdom
Birmingham, United Kingdom
Bristol, United Kingdom
Sheffield, United Kingdom
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.
Visioncare Research Ltd.
  More Information

Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT01180998     History of Changes
Other Study ID Numbers: CR-201004
First Submitted: August 11, 2010
First Posted: August 13, 2010
Results First Submitted: November 29, 2011
Results First Posted: December 20, 2013
Last Update Posted: July 6, 2017
Last Verified: June 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Astigmatism
Refractive Errors
Eye Diseases