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

Sponsor
Johnson & Johnson Vision Care, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01180998
Collaborator
Visioncare Research Ltd. (Other)
200
Enrollment
18
Locations
3
Arms
4
Actual Duration (Months)
11.1
Patients Per Site
2.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or DiseaseIntervention/TreatmentPhase
  • Device: Senofilcon A Toric (AOfA)
  • Device: Etafilcon A Toric (1DAMfA)
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Actual Study Start Date :
Jun 1, 2010
Actual Primary Completion Date :
Oct 1, 2010
Actual Study Completion Date :
Oct 1, 2010

Arms and Interventions

ArmIntervention/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

Outcome Measures

Primary Outcome Measures

  1. Overall Success in Fitting With a Toric Contact Lens [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.

  2. Distance Visual Acuity [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.

  3. Distance Visual Acuity (VA) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
Subjects must satisfy the following conditions prior to inclusion in the study:
  1. One of the following:

  2. Spherical contact lens user (minimum of 2 months wear, four days a week, 8 hours a day)

  3. 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)

  4. 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.

  5. Between 16 and 60 years of age.

  6. Have signed an informed consent form (documented by the investigator in the Case Report Form [CRF]).

  7. Distance requirement in the range of +4.00D to -9.00D (i.e. -10.00D refractive)

  8. Refractive astigmatism between -0.75D and -3.00D in both eyes.

  9. Have best corrected VA of 6/9 (20/30) or better in each eye.

  10. Have normal eyes with no evidence of abnormality or disease. For the purpose of this study a normal eye is defined as one having:

  11. No amblyopia.

  12. No evidence of lid abnormality or infection.

  13. No conjunctival abnormality or infection.

  14. No clinically significant slit lamp findings (i.e. stromal haze, staining, scarring, vascularisation, infiltrates or abnormal opacities).

  15. No other active ocular disease.

  16. 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

Locations

SiteCityStateCountryPostal Code
1ReadingBerkshireUnited Kingdom
2MarlowBucksUnited Kingdom
3BroadstoneDorsetUnited Kingdom
4PortchesterHampshireUnited Kingdom
5SouthseaHampshireUnited Kingdom
6St. AlbansHertsUnited Kingdom
7ShanklinIsle Of WightUnited Kingdom
8RawtenstallLancashireUnited Kingdom
9HendonLondonUnited Kingdom
10PinnerMiddlesexUnited Kingdom
11TeddingtonMiddlesexUnited Kingdom
12UxbridgeMiddlesexUnited Kingdom
13CardiffSouth GlamorganUnited Kingdom
14CroydonSurreyUnited Kingdom
15CoventryWest MidlandsUnited Kingdom
16BirminghamUnited Kingdom
17BristolUnited Kingdom
18SheffieldUnited Kingdom

Sponsors and Collaborators

  • Johnson & Johnson Vision Care, Inc.
  • Visioncare Research Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier:
NCT01180998
Other Study ID Numbers:
  • CR-201004
First Posted:
Aug 13, 2010
Last Update Posted:
Jun 19, 2018
Last Verified:
Jun 1, 2017
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
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment DetailsSubjects were recruited and randomized to one of two parallel arms. Three categories of subjects were recruited: spherical soft lens wearers, CL drop-outs, neophytes.
Pre-assignment DetailThe data from 10 subjects was disqualified from the analysis due to subjects' ineligibility being determined after enrollment.
Arm/Group TitleSpherical Contact Lens UsersContact Lens Drop-outsHabitual Correction With Spectacles (Neophytes)
Arm/Group DescriptionHabitual spherical contact lens (non-toric lens) users used one of two toric lenses in a daily wear modality.Habitual spectacle users (for vision correction) who have failed contact lens fit and wear, used one of two toric lenses in a daily wear modality.Habitual spectacle lens wearers (for vision correction) who have never used or been fitted with contact lenses used one of two toric lenses in a daily wear modality.
Period Title: Overall Study
STARTED677261
COMPLETED636851
NOT COMPLETED4410

Baseline Characteristics

Arm/Group TitleSpherical Contact Lens UsersContact Lens Drop-outsHabitual Correction With Spectacles (Neophytes)Total
Arm/Group DescriptionHabitual spherical contact lens (non-toric lens) users used one of two toric lenses in a daily wear modality.Habitual spectacle users (for vision correction) who have failed contact lens fit and wear, and used one of two toric lenses in a daily wear modality.Habitual spectacle lens wearers (for vision correction) who have never used or been fitted with contact lenses used one of two toric lenses in a daily wear modality.Total of all reporting groups
Overall Participants677261200
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
36.6
(11.8)
39.2
(10.0)
32.4
(12.3)
36.3
(11.6)
Sex: Female, Male (Count of Participants)
Female
20
29.9%
18
25%
33
54.1%
71
35.5%
Male
47
70.1%
54
75%
28
45.9%
129
64.5%
Region of Enrollment (participants) [Number]
United Kingdom
67
100%
72
100%
61
100%
200
100%

Outcome Measures

1. Primary Outcome
TitleOverall Success in Fitting With a Toric Contact Lens
DescriptionPercent 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.
Time Frame4 weeks

Outcome Measure Data

Analysis Population Description
All subjects that were dispensed a study lens except those that discontinued for non-clinical reasons.
Arm/Group TitleSpherical Contact Lens UsersContact Lens Drop-outsHabitual Correction With Spectacles (Neophytes)
Arm/Group DescriptionHabitual spherical contact lens (non-toric lens) users used one of two toric lenses in a daily wear modality.Habitual spectacle users (for vision correction) who have failed contact lens fit and wear, and used one of two toric lenses in a daily wear modality.Habitual spectacle lens wearers (for vision correction) who have never used or been fitted with contact lenses used one of two toric lenses in a daily wear modality.
Measure Participants667056
Number (95% Confidence Interval) [percentage of participants]
80
119.4%
74
102.8%
70
114.8%
2. Primary Outcome
TitleDistance Visual Acuity
DescriptionMeasured 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.
Time Frameafter 1 week of toric contact lens wear

Outcome Measure Data

Analysis Population Description
All subjects that were dispensed a study lens except those that discontinued for non-clinical reasons.
Arm/Group TitleSpherical Contact Lens UsersContact Lens Drop-outsHabitual Correction With Spectacles (Neophytes)
Arm/Group DescriptionHabitual spherical contact lens (non-toric lens) users used one of two toric lenses in a daily wear modality.Habitual spectacle users (for vision correction) who have failed contact lens fit and wear, and used one of two toric lenses in a daily wear modality.Habitual spectacle lens wearers (for vision correction) who have never used or been fitted with contact lenses used one of two toric lenses in a daily wear modality.
Measure Participants677261
Measure eyes128136102
1DAMfa Lens
-0.03
(0.01)
0.01
(0.01)
0.01
(0.01)
AofA Lens
-0.01
(0.01)
0.05
(0.02)
0.02
(0.02)
Total Monocular VA
-0.02
(0.01)
0.02
(0.01)
0.02
(0.01)
3. Primary Outcome
TitleDistance Visual Acuity (VA)
DescriptionVisual 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.
Time Frameafter 4 weeks of toric contact lens wear

Outcome Measure Data

Analysis Population Description
All subjects that were dispensed a study lens except those that discontinued for non-clinical reasons.
Arm/Group TitleSpherical Contact Lens UsersContact Lens Drop-outsHabitual Correction With Spectacles (Neophytes)
Arm/Group DescriptionHabitual spherical contact lens (non-toric lens) users used one of two toric lenses in a daily wear modality.Habitual spectacle users (for vision correction) who have failed contact lens fit and wear, used one of two toric lenses in a daily wear modality.Habitual spectacle lens wearers (for vision correction) who have never used or been fitted with contact lenses used one of two toric lenses in a daily wear modality.
Measure Participants636851
Measure eyes12413294
1DAMfa Lens
-0.03
(0.01)
0.01
(0.01)
0.01
(0.01)
AOfA Lens
0.01
(0.01)
0.04
(0.02)
0.02
(0.02)
Total Monocular VA
-0.02
(0.01)
0.02
(0.01)
0.00
(0.01)

Adverse Events

Time Frame
Adverse Event Reporting Description
Arm/Group TitleSpherical Contact Lens UsersContact Lens Drop-outsHabitual Correction With Spectacles (Neophytes)
Arm/Group DescriptionHabitual spherical contact lens (non-toric lens) users will use one of two toric lenses in a daily wear modality.Habitual spectacle users (for vision correction) who have failed contact lens fit and wear, will use one of two toric lenses in a daily wear modality.Habitual spectacle lens wearers (for vision correction) who have never used or been fitted with contact lenses will use one of two toric lenses in a daily wear modality.
All Cause Mortality
Spherical Contact Lens UsersContact Lens Drop-outsHabitual Correction With Spectacles (Neophytes)
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total/ (NaN) / (NaN) / (NaN)
Serious Adverse Events
Spherical Contact Lens UsersContact Lens Drop-outsHabitual Correction With Spectacles (Neophytes)
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/67 (0%) 0/72 (0%) 0/61 (0%)
Other (Not Including Serious) Adverse Events
Spherical Contact Lens UsersContact Lens Drop-outsHabitual Correction With Spectacles (Neophytes)
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/67 (0%) 0/72 (0%) 0/61 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Publication required agreement and written authorization from the Sponsor.

Results Point of Contact

Name/TitleKathy Osborn, OD
OrganizationJohnson & Johnson Vision Care
Phone1-904-443-1032
EmailKOsborn@its.jnj.com
Responsible Party:
Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier:
NCT01180998
Other Study ID Numbers:
  • CR-201004
First Posted:
Aug 13, 2010
Last Update Posted:
Jun 19, 2018
Last Verified:
Jun 1, 2017