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

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).

Study Overview

• Status: Completed
• Conditions: Astigmatism
• Intervention / Treatment: Device: Senofilcon A Toric (AOfA); Device: Etafilcon A Toric (1DAMfA)

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Birmingham, United Kingdom
  • Bristol, United Kingdom
  • Sheffield, United Kingdom
  • Berkshire
    • Reading, Berkshire, United Kingdom
  • Bucks
    • Marlow, Bucks, United Kingdom
  • Dorset
    • Broadstone, Dorset, United Kingdom
  • Hampshire
    • Portchester, Hampshire, United Kingdom
    • Southsea, Hampshire, United Kingdom
  • Herts
    • St. Albans, Herts, United Kingdom
  • Isle Of Wight
    • Shanklin, Isle Of Wight, United Kingdom
  • Lancashire
    • Rawtenstall, Lancashire, United Kingdom
  • London
    • Hendon, London, United Kingdom
  • Middlesex
    • Pinner, Middlesex, United Kingdom
    • Teddington, Middlesex, United Kingdom
    • Uxbridge, Middlesex, United Kingdom
  • South Glamorgan
    • Cardiff, South Glamorgan, United Kingdom
  • Surrey
    • Croydon, Surrey, United Kingdom
  • West Midlands
    • Coventry, West Midlands, United Kingdom

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 60 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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
OTHER: 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
OTHER: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Success in Fitting With a Toric Contact Lens	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.	4 weeks
Distance Visual Acuity	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.	after 1 week of toric contact lens wear
Distance Visual Acuity (VA)	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.	after 4 weeks of toric contact lens wear

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.
• Collaborators: Visioncare Research Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2010
• Primary Completion (ACTUAL): October 1, 2010
• Study Completion (ACTUAL): October 1, 2010

Study Registration Dates

• First Submitted: August 11, 2010
• First Submitted That Met QC Criteria: August 12, 2010
• First Posted (ESTIMATE): August 13, 2010

Study Record Updates

• Last Update Posted (ACTUAL): June 19, 2018
• Last Update Submitted That Met QC Criteria: June 18, 2018
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: CR-201004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes