Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Visioncare Research Ltd. | OTHER |
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spherical contact lens users | Other | Habitual spherical contact lens (non-toric lens) users tried one of two toric lenses in a daily wear modality. |
|
| Contact lens drop-outs | Other | 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. |
|
| Habitual Correction with Spectacles (Neophytes) | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Senofilcon A Toric (AOfA) | Device | Soft toric contact lenses for astigmatism |
|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Subjects must satisfy the following conditions prior to inclusion in the study:
One of the following:
Between 16 and 60 years of age.
Have signed an informed consent form (documented by the investigator in the Case Report Form [CRF]).
Distance requirement in the range of +4.00D to -9.00D (i.e. -10.00D refractive)
Refractive astigmatism between -0.75D and -3.00D in both eyes.
Have best corrected VA of 6/9 (20/30) or better in each eye.
Have normal eyes with no evidence of abnormality or disease. For the purpose of this study a normal eye is defined as one having:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reading | Berkshire | United Kingdom | ||||
The data from 10 subjects was disqualified from the analysis due to subjects' ineligibility being determined after enrollment.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Spherical Contact Lens Users | Habitual spherical contact lens (non-toric lens) users used one of two toric lenses in a daily wear modality. |
| FG001 | Contact Lens Drop-outs | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Etafilcon A Toric (1DAMfA) | Device | Soft toric contact lenses for astigmatism |
|
| 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 |
| FG002 | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Baseline characteristics are of those subjects that met the inclusion/ exclusion criteria and are enrolled and randomized to a study arm.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Spherical Contact Lens Users | Habitual spherical contact lens (non-toric lens) users used one of two toric lenses in a daily wear modality. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All subjects that were dispensed a study lens except those that discontinued for non-clinical reasons. | Posted | Number | 95% Confidence Interval | percentage of participants | 4 weeks |
|
|
| |||||||||||||||||||||||||||||||
| 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. | All subjects that were dispensed a study lens except those that discontinued for non-clinical reasons. | Posted | Least Squares Mean | Standard Error | logMAR | after 1 week of toric contact lens wear | eyes | eyes |
| |||||||||||||||||||||||||||||||
| 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. | All subjects that were dispensed a study lens except those that discontinued for non-clinical reasons. | Posted | Least Squares Mean | Standard Error | logMAR | after 4 weeks of toric contact lens wear | eyes | eyes |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Spherical Contact Lens Users | Habitual spherical contact lens (non-toric lens) users will use one of two toric lenses in a daily wear modality. | 0 | 67 | 0 | 67 | ||
| EG001 | Contact Lens Drop-outs | 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. | 0 | 72 | 0 | 72 | ||
| EG002 | Habitual Correction With Spectacles (Neophytes) | 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. | 0 | 61 | 0 | 61 |
Not provided
Not provided
Publication required agreement and written authorization from the Sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathy Osborn, OD | Johnson & Johnson Vision Care | 1-904-443-1032 | KOsborn@its.jnj.com |
| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
| Male |
|
| Units | Counts |
|---|---|
| Participants |
|
| eyes |
|
|
| Units | Counts |
|---|---|
| Participants |
|
| eyes |
|
|