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The purpose of this research is to measure daytime open-eye response to wearing of narafilcon B lenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spectacles No Lenses | Placebo Comparator | Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations. |
|
| narafilcon B | Experimental | Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations. |
|
| polymacon | Active Comparator | Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations. |
|
| lotrafilcon A | Active Comparator | Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| narafilcon B | Device | test product |
| |
| Polymacon |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal Thickness | Percentage of corneal swelling (positive value) or deswelling (negative value) measured with Haag-Streit pachymetry equipment in microns, reported as a percent. | After 8 hours of contact lens wear |
| Endothelial Blebs | Corneal images captured with equipment are measured, manually outlined to estimate total bleb area from 0 to 100%. This is measured as a change in percentage after 20 minutes compared to the value prior to lens wear (baseline). | baseline, after 20 minutes of treatment conditions |
| Limbal Redness | Scale of 0 to 4, where 0=none and 4= severe redness. Measure reported as a comparison of 8 hours of wear to baseline with the difference being reported. | Baseline, After 8 hours of treatment conditions |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Comfort | Patient reported subjective comfort of lenses or spectacles (range 0-100, where 100 is best). | after 8 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Noel Brennan, McOptom PhD | Coles-Brennan Pty Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coles-Brennan Pty Ltd | Hawthorn | Victoria | Australia |
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There were 22 subjects enrolled to the study, all completed the four experimental sessions.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations. The four arms were Spectacles (no contact lenses), Narafilcon B, Polymacon A, and Lotrafilcon A, in random order during the sessions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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| Period 3 |
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| Period 4 |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | Subjects who were enrolled and randomized to a trial arm. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Corneal Thickness | Percentage of corneal swelling (positive value) or deswelling (negative value) measured with Haag-Streit pachymetry equipment in microns, reported as a percent. | Subjects are those enrolled and randomized to a trial arm. | Posted | Least Squares Mean | Standard Error | Percent Change | After 8 hours of contact lens wear |
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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 | Spectacles No Lenses | Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Noel Brennan | Vistakon | 1 904 4433494 | nbrenna2@its.jnj.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D005139 | Eyeglasses |
| ID | Term |
|---|---|
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
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| Device |
marketed product |
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| Lotrafilcon A | Device | marketed product |
|
| Spectacles | Other | None - subject used own spectacles |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Polymacon | Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations. |
| OG003 | Lotrafilcon A | Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations. |
|
|
|
| Primary | Endothelial Blebs | Corneal images captured with equipment are measured, manually outlined to estimate total bleb area from 0 to 100%. This is measured as a change in percentage after 20 minutes compared to the value prior to lens wear (baseline). | Posted | Mean | Standard Error | percentage of bleb area | baseline, after 20 minutes of treatment conditions |
|
|
|
|
| Primary | Limbal Redness | Scale of 0 to 4, where 0=none and 4= severe redness. Measure reported as a comparison of 8 hours of wear to baseline with the difference being reported. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, After 8 hours of treatment conditions |
|
|
|
|
| Secondary | Overall Comfort | Patient reported subjective comfort of lenses or spectacles (range 0-100, where 100 is best). | Posted | Least Squares Mean | Standard Error | units on a scale | after 8 hours |
|
|
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|
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Narafilcon B | Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations. | 0 | 22 | 0 | 22 |
| EG002 | Polymacon A | Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations. | 0 | 22 | 0 | 22 |
| EG003 | Lotrafilcon A | Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations. | 0 | 22 | 0 | 22 |
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Ho: Polymacon (+ control) - Narafilcon B (test) = 0. Ha: Polymacon (+ control) - Narafilcon B (test) ≠ 0. |
| Mixed Models Analysis |
| 0.7301 |
| Mean Difference (Final Values) |
| -0.0011 |
| Standard Error of the Mean |
| 0.0032 |
| 95 |
The mean difference is calculated as: Control-Test. |
| Superiority or Other |
| Ho: lotrafilcon A (control) - narafilcon B (test) = 0. Ha: lotrafilcon A (control) - narafilcon B (test) ≠ 0. | Mixed Models Analysis | 0.8055 | Mean Difference (Final Values) | -0.0008 | Standard Error of the Mean | 0.0032 | 95 | The mean difference is calculated as: Control-Test. | Superiority or Other |
Ho: Polymacon (+ control) - Narafilcon B (test) = 0. Ha: Polymacon (+ control) - Narafilcon B (test) ≠ 0. |
| Mixed Models Analysis |
| 0.0000 |
| Mean Difference (Final Values) |
| 0.6864 |
| Standard Error of the Mean |
| 0.1098 |
| 95 |
The mean difference is calculated as: Control-Test. |
| Superiority or Other |
| Ho: lotrafilcon A (control) - narafilcon B (test) = 0. Ha: lotrafilcon A (control) - narafilcon B (test) ≠ 0. | Mixed Models Analysis | 0.1256 | Mean Difference (Final Values) | 0.1705 | Standard Error of the Mean | 0.1098 | 95 | The mean difference is calculated as: Control-Test. | Superiority or Other |
Ho: Polymacon (+ control) - Narafilcon B (test) = 0. Ha: Polymacon (+ control) - Narafilcon B (test) ≠ 0. |
| Mixed Models Analysis |
| 0.0007 |
| Mean Difference (Final Values) |
| -17.75 |
| Standard Error of the Mean |
| 4.984 |
| 95 |
The mean difference is calculated as: Control-Test. |
| Superiority or Other |
| Ho: lotrafilcon A (control) - narafilcon B (test) = 0. Ha: lotrafilcon A (control) - narafilcon B (test) ≠ 0. | Mixed Models Analysis | 0.0030 | Mean Difference (Final Values) | -15.37 | Standard Error of the Mean | 4.984 | 95 | The mean difference is calculated as: Control-Test. | Superiority or Other |