Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a prospective, single site, unmasked, cross-over study with three silicone hydrogel contact lenses comparing central corneal swelling.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| etafilcon A/lotrafilcon B/comfilcon A | Active Comparator | Subjects that were randomized to receive the etafilcon A lens 1st, the lotrafilcon B lens 2nd and the comfilcon A lens 3rd. |
|
| etafilcon A/comfilcon A/lotrafilcon B | Active Comparator | Subjects that were randomized to receive the etafilcon A lens 1st, the comfilcon A lens 2nd and the lotrafilcon B lens 3rd. |
|
| comfilcon A/etafilcon A/lotrafilcon B | Active Comparator | Subjects that were randomized to receive the comfilcon A lens 1st, the etafilcon A lens 2nd and the lotrafilcon B lens 3rd. |
|
| comfilcon A/lotrafilcon B/etafilcon A | Active Comparator | Subjects that were randomized to receive the comfilcon A lens 1st, the lotrafilcon B lens 2nd and the etafilcon A lens 3rd. |
|
| lotrafilcon B/etafilcon A/comfilcon A | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etafilcon A | Device | spherical hydrophilic soft contact lens worn in a daily wear modality |
|
| Measure | Description | Time Frame |
|---|---|---|
| Central Corneal Swelling | Corneal swelling measurements were taken in the right eye during slit lamp evaluations, 6-8 hours post lens insertion. The average corneal swelling per lens was reported. | 6-8 Hours Post lens insertion |
| Measure | Description | Time Frame |
|---|---|---|
| Limbal Redness | Limbal redness was assessed in both eyes using a slit lamp, 6-8 hours post lens insertion. Redness was assessed in 4 regions of the eye (nasal, temporal, inferior and superior) and was graded with a 5-point scale (i.e. Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). For each region (nasal, temporal, inferior and superior) the average grade was calculated by lens. The Total Grade was then calculated by summing all the average grade for each region. The regional average grade ranges from 0 to 4. The total Grade ranges from 0 to 16. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland | Ohio | 44124 | United States |
A total of 41 subjects were enrolled in this study. Of the enrolled subjects 3 did not meet the eligibility criteria and 38 subjects were dispensed a study lens. Of the dispensed subjects 2 were discontinued while 36 completed all study visits.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Etafilcon A/Lotrafilcon B/Comfilcon A | Subjects randomized to this sequence received etafilcon A during the 1st period, then received lotrafilcon B during the 2nd period, and then received comfilcon A during the last period. |
| FG001 | Etafilcon A/Comfilcon A/Lotrafilcon B | Subjects randomized to this sequence received etafilcon A during the 1st period, then received comfilcon A during the 2nd period, and then received lotrafilcon B during the last period. |
| FG002 | Lotrafilcon B/Etafilcon A/Comfilcon A | Subjects randomized to this sequence received lotrafilcon B during the 1st period, then received etafilcon A during the 2nd period, and then received comfilcon A during the last period. |
| FG003 | Lotrafilcon B/Comfilcon A/Etafilcon A | Subjects randomized to this sequence received lotrafilcon B during the 1st period, then received comfilcon A during the 2nd period, and then received etafilcon A during the last period. |
| FG004 | Comfilcon A/Etafilcon A/Lotrafilcon B | Subjects randomized to this sequence received comfilcon A during the 1st period, then received etafilcon A during the 2nd period, and then received lotrafilcon B during the last period. |
| FG005 | Comfilcon A/Lotrafilcon B/Etafilcon A | Subjects randomized to this sequence received comfilcon A during the 1st period, then received lotrafilcon B during the 2nd period, and then received etafilcon A during the last period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
|
| ||||||||||||||||||
| Period 2 |
| |||||||||||||||||||
| Period 3 |
|
All subjects that were dispensed at least one study lens.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Overall | All subjects that were dispensed at least one study lens. |
| 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 | Central Corneal Swelling | Corneal swelling measurements were taken in the right eye during slit lamp evaluations, 6-8 hours post lens insertion. The average corneal swelling per lens was reported. | All subjects that were dispensed at least one study lens throughout the duration of the study. | Posted | Mean | Standard Deviation | um | 6-8 Hours Post lens insertion |
|
Throughout the entire duration. Approximately 1-week per subject
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 | Etafilcon A | Subjects that wore the etafilcon A lens during any of the 3 period over the course of this study. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tawnya Wilson - PRINCIPAL RESEARCH OPTOMETRIST | Johnson & Johnson Vision Care Inc. | +1 904 443-1834 | TWilson@ITS.JNJ.com |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Subjects that were randomized to receive the lotrafilcon B lens 1st, the etafilcon A lens 2nd and the comfilcon A lens 3rd.
|
| lotrafilcon B/comfilcon A/etafilcon A | Active Comparator | Subjects that were randomized to receive the lotrafilcon B lens 1st, the comfilcon A lens 2nd and the etafilcon A lens 3rd. |
|
|
| lotrafilcon B | Device |
|
| comfilcon A | Device |
|
| 6-8 hours post lens insertion |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Comfilcon A | Subjects that wore the comfilcon A lens during any of the 3 period over the course of this study. |
|
|
| Secondary | Limbal Redness | Limbal redness was assessed in both eyes using a slit lamp, 6-8 hours post lens insertion. Redness was assessed in 4 regions of the eye (nasal, temporal, inferior and superior) and was graded with a 5-point scale (i.e. Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). For each region (nasal, temporal, inferior and superior) the average grade was calculated by lens. The Total Grade was then calculated by summing all the average grade for each region. The regional average grade ranges from 0 to 4. The total Grade ranges from 0 to 16. | All subjects that were dispensed at least one study lens throughout the duration of this study. | Posted | Mean | Standard Deviation | units on a scale | 6-8 hours post lens insertion |
|
|
|
| 0 |
| 37 |
| 0 |
| 37 |
| EG001 | Lotrafilcon B | Subjects that wore the lotrafilcon B lens during any of the 3 period over the course of this study. | 0 | 38 | 0 | 38 |
| EG002 | Comfilcon A | Subjects that wore the comfilcon A lens during any of the 3 period over the course of this study. | 0 | 36 | 0 | 36 |
Not provided