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| ID | Type | Description | Link |
|---|---|---|---|
| J07-416 |
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| Name | Class |
|---|---|
| University of Manchester | OTHER |
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The relative performance of a new toric soft contact lens against toric contact lenses currently available in market, specifically for visual acuity and lens orientation. The study will be conducted in a staged approach (2 stages).
Non-dispensing, single-masked (subject-masked), randomised, controlled study. Two visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 2 LSBO | Active Comparator | contact lenses worn in this order: lotrafilcon B toric, senofilcon A toric, balafilcon A toric, omafilcon A toric |
|
| Group 3 LOSB | Active Comparator | contact lenses worn in this order: lotrafilcon B toric, omafilcon A toric, senofilcon A toric, balafilcon A toric |
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| Group 4 LBSO | Active Comparator | contact lenses worn in this order: lotrafilcon B toric, balafilcon A toric, senofilcon A toric, omafilcon A toric |
|
| Group 5 LBOS | Active Comparator | contact lenses worn in this order: lotrafilcon B toric, balafilcon A toric, omafilcon A toric, senofilcon A |
|
| Group 6 SLOB | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| senofilcon A | Device | toric contact lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity After Infero-temporal Version Movement. | logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal. | 10 minutes after insertion |
| Visual Acuity After Infero-nasal Version Movement. | logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal. | 10 minutes after lens insertion |
| Visual Acuity After Superior-temporal Version Movement | logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal. | 10 minutes after lens insertion |
| Visual Acuity After Superior-nasal Version Movement. | logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal. | 10 minutes after lens insertion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip Morgan, PhD MCOptom | Eurolens Research, The University of Manchester Dpt. of Optometry and Neuroscience | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurolens Research, The University of Manchester Dpt. of Optometry & Neuroscience | Manchester | M60 1QD | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group1 LSOB | lotrafilcon b toric, senofilcon A toric, omafilcon A toric, balafilcon A toric |
| FG001 | Group 2 LSBO | lotrafilcon B toric, senofilcon A toric, balafilcon A toric, omafilcon A toric |
| FG002 | Group 4 LBSO | lotrafilcon B toric, balafilcon A toric, senofilcon A toric, omafilcon A toric |
| FG003 | Group 5 LBOS | lotrafilcon B toric, balafilcon A toric, omafilcon A toric, senofilcon A |
| FG004 | Group 7 SLBO | senofilcon A toric, lotrafilcon B toric, balafilcon A toric, omafilcon A toric |
| FG005 | Group 8 SOLB | senofilcon A toric, omafilcon A toric, lotrafilcon B toric, balafilcon A toric |
| FG006 | Group 9 SBLO | senofilcon A toric, balafilcon A toric, lotrafilcon B toric, omafilcon A toric |
| FG007 | Group 10 SBOL | senofilcon A toric, balafilcon A toric, omafilcon A toric, lotrafilcon B toric |
| FG008 | Group 11 OSLB | omafilcon A toric, senofilcon A toric, lotrafilcon B toric, balafilcon A toric |
| FG009 | Group 12 OSBL | omafilcon A toric, senofilcon A toric, balafilcon A toric, lotrafilcon B toric |
| FG010 | Group 13 OBLS | omafilcon A toric, balafilcon A toric, lotrafilcon B toric, senofilcon A toric |
| FG011 | Group 14 OBSL | omafilcon A toric, balafilcon A toric, senofilcon A toric, lotrafilcon B toric |
| FG012 | Group 15 BLSO | balafilcon A toric, lotrafilcon B toric, senofilcon A toric, omafilcon A toric |
| FG013 | Group 16 BLOS | balafilcon A toric, lotrafilcon B toric, omafilcon A toric, senofilcon A toric |
| FG014 | Group 18 BOLS | balafilcon A toric, omafilcon A toric, lotrafilcon B toric, senofilcon A toric |
| FG015 | Group 19 BOSL | balafilcon A toric, omafilcon A toric, senofilcon A toric, lotrafilcon B toric |
| FG016 | Group 3 LOSB | lotrafilcon B toric, omafilcon A toric, senofilcon A toric, balafilcon A toric |
| FG017 | Group 6 SLOB | senofilcon A toric, lotrafilcon b toric, omafilcon A toric, balafilcon A toric |
| FG018 | Group 17 BSOL | balafilcon A toric, senofilcon A toric,omafilcon A toric, lotrafilcon b toric |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention 1 |
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| Intervention 2 |
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| Intervention 3 |
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| Intervention 4 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Total Study Population |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Visual Acuity After Infero-temporal Version Movement. | logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal. | Posted | Mean | Standard Deviation | LogMAR units | 10 minutes after insertion |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lotrafilcon B | lotrafilcon b toric contact lens |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kurt Moody, OD, FAAO | Vistakon | 904-443-3088 | kmoody1@its.jnj.com |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| D000072458 | Orientation, Spatial |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
| D013037 | Spatial Behavior |
| D001519 | Behavior |
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contact lenses worn in this order: senofilcon A toric, lotrafilcon B toric, omafilcon A toric, balafilcon A toric
|
| Group 7 SLBO | Active Comparator | contact lenses worn in this order: senofilcon A toric, lotrafilcon B toric, balafilcon A toric, omafilcon A toric |
|
| Group 8 SOLB | Active Comparator | contact lenses worn in this order: senofilcon A toric, omafilcon A toric, lotrafilcon B toric, balafilcon A toric |
|
| Group 9 SBLO | Active Comparator | contact lenses worn in this order: senofilcon A toric, balafilcon A toric, lotrafilcon B toric, omafilcon A toric |
|
| Group 10 SBOL | Active Comparator | contact lenses worn in this order: senofilcon A toric, balafilcon A toric, omafilcon A toric, lotrafilcon B toric |
|
| Group 11 OSLB | Active Comparator | contact lenses worn in this order: omafilcon A toric, senofilcon A toric, lotrafilcon B toric, balafilcon A toric |
|
| Group 12 OSBL | Active Comparator | contact lenses worn in this order: omafilcon A toric, senofilcon A toric, balafilcon A toric, lotrafilcon B toric |
|
| Group 13 OBLS | Active Comparator | contact lenses worn in this order: omafilcon A toric, balafilcon A toric, lotrafilcon B toric, senofilcon A toric |
|
| Group 14 OBSL | Active Comparator | contact lenses worn in this order: omafilcon A toric, balafilcon A toric, senofilcon A toric, lotrafilcon B toric |
|
| Group 15 BLSO | Active Comparator | contact lenses worn in this order: balafilcon A toric, lotrafilcon B toric, senofilcon A toric, omafilcon A toric |
|
| Group 16 BLOS | Active Comparator | contact lenses worn in this order: balafilcon A toric, lotrafilcon B toric, omafilcon A toric, senofilcon A toric |
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| Group 17 BSOL | Active Comparator | contact lenses worn in this order: balafilcon A toric, senofilcon A toric, omafilcon A toric, lotrafilcon B toric |
|
| Group 18 BOLS | Active Comparator | contact lenses worn in this order: balafilcon A toric, omafilcon A toric, lotrafilcon B toric, senofilcon A toric |
|
| Group 19 BOSL | Active Comparator | contact lenses worn in this order: balafilcon A toric, omafilcon A toric, senofilcon A toric, lotrafilcon B toric |
|
| Group 1 LSOB | Active Comparator | contact lenses worn in this order: lotrafilcon B toric/senofilcon A toric/omafilconA toric/balafilcon A toric |
|
| balafilcon A | Device | toric contact lens |
|
| omafilcon A | Device | toric contact lens |
|
| lotrafilcon B | Device | toric contact lens |
|
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
omafilcon A toric
| OG003 | Balafilcon A | balafilcon A toric |
|
|
|
| Primary | Visual Acuity After Infero-nasal Version Movement. | logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal. | Posted | Mean | Standard Deviation | LogMAR units | 10 minutes after lens insertion |
|
|
|
|
| Primary | Visual Acuity After Superior-temporal Version Movement | logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal. | Posted | Mean | Standard Deviation | LogMAR units | 10 minutes after lens insertion |
|
|
|
|
| Primary | Visual Acuity After Superior-nasal Version Movement. | logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal. | Posted | Mean | Standard Deviation | LogMAR units | 10 minutes after lens insertion |
|
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Senofilcon A | senofilcon A toric contact lens | 0 | 40 | 0 | 40 |
| EG002 | Omafilcon A | omafilcon A toric contact lens | 0 | 40 | 0 | 40 |
| EG003 | Balafilcon A | balafilcon A toric contact lens | 0 | 40 | 0 | 40 |
The PI may not publish, divulge, reveal, disclose, or use the data and or results of the study without prior written consent of Vistakon.
Hypothesis is that visual acuity is the same for all lens types.
| ANOVA |
| 0.02 |
| Mean Difference (Final Values) |
| -0.01 |
| Standard Deviation |
| 0.17 |
| 95 |
| Yes |
| Non-Inferiority or Equivalence |
The non-inferiority margin is 0.05 |
| Hypothesis is that visual acuity is the same for all lens types. | ANOVA | 0.02 | Mean Difference (Final Values) | -0.03 | Standard Deviation | 0.17 | 95 | Yes | Non-Inferiority or Equivalence | The non-inferiority margin is 0.05 |
| Hypothesis is that visual acuity is the same for all lens types. | ANOVA | 0.02 | Mean Difference (Final Values) | -0.03 | Standard Deviation | 0.19 | 95 | Yes | Non-Inferiority or Equivalence | The non-inferiority margin is 0.05 |
| Hypothesis is that visual acuity is the same for all lens types. | ANOVA | 0.02 | Mean Difference (Final Values) | -0.04 | Standard Deviation | 0.20 | 95 | Yes | Non-Inferiority or Equivalence | The non-inferiority margin is 0.05 |
| Hypothesis is that visual acuity is the same for all lens types. | ANOVA | 0.02 | Mean Difference (Final Values) | -0.02 | Standard Deviation | 0.17 | 95 | Yes | Non-Inferiority or Equivalence | The non-inferiority margin is 0.05 |
Hypothesis is that visual acuity is the same for all lens types.
| ANOVA |
| 0.02 |
| Mean Difference (Final Values) |
| -0.01 |
| Standard Deviation |
| 0.15 |
| 95 |
| Yes |
| Non-Inferiority or Equivalence |
The non-inferiority margin is 0.05 |
| Hypothesis is that visual acuity is the same for all lens types. | ANOVA | 0.02 | Mean Difference (Final Values) | -0.02 | Standard Deviation | 0.17 | 95 | Yes | Non-Inferiority or Equivalence | The non-inferiority margin is 0.05 |
| Hypothesis is that visual acuity is the same for all lens types. | ANOVA | 0.02 | Mean Difference (Final Values) | -0.04 | Standard Deviation | 0.15 | 95 | Yes | Non-Inferiority or Equivalence | The non-inferiority margin is 0.05 |
| Hypothesis is that visual acuity is the same for all lens types. | ANOVA | 0.02 | Mean Difference (Final Values) | -0.06 | Standard Deviation | 0.17 | 95 | Yes | Non-Inferiority or Equivalence | The non-inferiority margin is 0.05 |
| Hypothesis is that visual acuity is the same for all lens types. | ANOVA | 0.02 | Mean Difference (Final Values) | -0.01 | Standard Deviation | 0.18 | 95 | Yes | Non-Inferiority or Equivalence | The non-inferiority margin is 0.05 |
Hypothesis is that visual acuity is the same for all lens types.
| ANOVA |
| 0.02 |
| Mean Difference (Final Values) |
| -0.01 |
| Standard Deviation |
| 0.19 |
| 95 |
| Yes |
| Non-Inferiority or Equivalence |
The non-inferiority margin is 0.05 |
| Hypothesis is that visual acuity is the same for all lens types. | ANOVA | 0.02 | Mean Difference (Final Values) | -0.02 | Standard Deviation | 0.20 | 95 | Yes | Non-Inferiority or Equivalence | The non-inferiority margin is 0.05 |
| Hypothesis is that visual acuity is the same for all lens types. | ANOVA | 0.02 | Mean Difference (Final Values) | -0.05 | Standard Deviation | 0.15 | 95 | Yes | Non-Inferiority or Equivalence | The non-inferiority margin is 0.05 |
| Hypothesis is that visual acuity is the same for all lens types. | ANOVA | 0.02 | Mean Difference (Final Values) | -0.06 | Standard Deviation | 0.18 | 95 | Yes | Non-Inferiority or Equivalence | The non-inferiority margin is 0.05 |
| Hypothesis is that visual acuity is the same for all lens types. | ANOVA | 0.02 | Mean Difference (Final Values) | -0.01 | Standard Deviation | 0.18 | 95 | Yes | Non-Inferiority or Equivalence | The non-inferiority margin is 0.05 |