Astigmatism
Conditions
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).
Interventions
DEVICESenofilcon A Toric (AOfA)
Soft toric contact lenses for astigmatism
DEVICEEtafilcon A Toric (1DAMfA)
Soft toric contact lenses for astigmatism
Sponsors
Visioncare Research Ltd.
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
United Kingdom
Participant flow
Recruitment details
Subjects 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 details
The data from 10 subjects was disqualified from the analysis due to subjects' ineligibility being determined after enrollment.
Participants by arm
| Arm | Count |
|---|---|
| Spherical Contact Lens Users Habitual spherical contact lens (non-toric lens) users used one of two toric lenses in a daily wear modality. | 67 |
| Contact Lens Drop-outs 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. | 72 |
| Habitual Correction With Spectacles (Neophytes) 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. | 61 |
| Total | 200 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 1 |
| Overall Study | Poor comfort | 3 | 0 | 4 |
| Overall Study | Poor lens handling | 0 | 0 | 2 |
| Overall Study | Poor Vision | 0 | 2 | 2 |
| Overall Study | Protocol Violation | 1 | 2 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Spherical Contact Lens Users | Contact Lens Drop-outs | Habitual Correction With Spectacles (Neophytes) | Total |
|---|---|---|---|---|
| Age, Continuous | 36.6 years STANDARD_DEVIATION 11.8 | 39.2 years STANDARD_DEVIATION 10 | 32.4 years STANDARD_DEVIATION 12.3 | 36.3 years STANDARD_DEVIATION 11.6 |
| Region of Enrollment United Kingdom | 67 participants | 72 participants | 61 participants | 200 participants |
| Sex: Female, Male Female | 20 Participants | 18 Participants | 33 Participants | 71 Participants |
| Sex: Female, Male Male | 47 Participants | 54 Participants | 28 Participants | 129 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 67 | 0 / 72 | 0 / 61 |
| serious Total, serious adverse events | 0 / 67 | 0 / 72 | 0 / 61 |
Outcome results
Primary
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.
Time frame: after 1 week of toric contact lens wear
Population: All subjects that were dispensed a study lens except those that discontinued for non-clinical reasons.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Spherical Contact Lens Users | Distance Visual Acuity | AofA Lens | -0.01 logMAR | Standard Error 0.01 |
| Spherical Contact Lens Users | Distance Visual Acuity | 1DAMfa Lens | -0.03 logMAR | Standard Error 0.01 |
| Spherical Contact Lens Users | Distance Visual Acuity | Total Monocular VA | -0.02 logMAR | Standard Error 0.01 |
| Contact Lens Drop-outs | Distance Visual Acuity | AofA Lens | 0.05 logMAR | Standard Error 0.02 |
| Contact Lens Drop-outs | Distance Visual Acuity | 1DAMfa Lens | 0.01 logMAR | Standard Error 0.01 |
| Contact Lens Drop-outs | Distance Visual Acuity | Total Monocular VA | 0.02 logMAR | Standard Error 0.01 |
| Habitual Correction With Spectacles (Neophytes) | Distance Visual Acuity | 1DAMfa Lens | 0.01 logMAR | Standard Error 0.01 |
| Habitual Correction With Spectacles (Neophytes) | Distance Visual Acuity | Total Monocular VA | 0.02 logMAR | Standard Error 0.01 |
| Habitual Correction With Spectacles (Neophytes) | Distance Visual Acuity | AofA Lens | 0.02 logMAR | Standard Error 0.02 |
Primary
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.
Time frame: after 4 weeks of toric contact lens wear
Population: All subjects that were dispensed a study lens except those that discontinued for non-clinical reasons.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Spherical Contact Lens Users | Distance Visual Acuity (VA) | AOfA Lens | 0.01 logMAR | Standard Error 0.01 |
| Spherical Contact Lens Users | Distance Visual Acuity (VA) | 1DAMfa Lens | -0.03 logMAR | Standard Error 0.01 |
| Spherical Contact Lens Users | Distance Visual Acuity (VA) | Total Monocular VA | -0.02 logMAR | Standard Error 0.01 |
| Contact Lens Drop-outs | Distance Visual Acuity (VA) | AOfA Lens | 0.04 logMAR | Standard Error 0.02 |
| Contact Lens Drop-outs | Distance Visual Acuity (VA) | 1DAMfa Lens | 0.01 logMAR | Standard Error 0.01 |
| Contact Lens Drop-outs | Distance Visual Acuity (VA) | Total Monocular VA | 0.02 logMAR | Standard Error 0.01 |
| Habitual Correction With Spectacles (Neophytes) | Distance Visual Acuity (VA) | 1DAMfa Lens | 0.01 logMAR | Standard Error 0.01 |
| Habitual Correction With Spectacles (Neophytes) | Distance Visual Acuity (VA) | Total Monocular VA | 0.00 logMAR | Standard Error 0.01 |
| Habitual Correction With Spectacles (Neophytes) | Distance Visual Acuity (VA) | AOfA Lens | 0.02 logMAR | Standard Error 0.02 |
Primary
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.
Time frame: 4 weeks
Population: All subjects that were dispensed a study lens except those that discontinued for non-clinical reasons.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Spherical Contact Lens Users | Overall Success in Fitting With a Toric Contact Lens | 80 percentage of participants |
| Contact Lens Drop-outs | Overall Success in Fitting With a Toric Contact Lens | 74 percentage of participants |
| Habitual Correction With Spectacles (Neophytes) | Overall Success in Fitting With a Toric Contact Lens | 70 percentage of participants |