Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine if the formation of mucin balls is a marker for protection from inflammatory events to the cornea and if mucin balls play a role in protection during extended contact lens wear.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lotrafilcon A, comfilcon A | Active Comparator | All subjects are assigned to lotrafilcon A during a run-in (Phase 1) and then randomized to one of two lenses. This arm is assigned to comfilcon A at phase 2. Subjects classified as a Neophyte wore etafilcon A for 2-weeks before entering the run-in period in Phase I. |
|
| lotrafilcon A, balafilcon A | Active Comparator | All subjects are assigned to lotrafilcon A during a run-in (Phase 1) and then randomized to one of two lenses. This arm is assigned to balafilcon A at phase 2. Subjects classified as a Neophyte wore etafilcon A for 2-weeks before entering the run-in period in Phase I. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lotrafilcon A | Device | To be used during run-in phase only. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Corneal Infiltrate Events - Phase I | The percentage of Subjects that experienced Corneal Inflammatory Events within their Mucin Ball classification. | 1-Month Follow-up |
| Corneal Infiltrate Event- Phase II | The percentage of Subjects that experienced Corneal Inflammatory Events within their Mucin Ball classification. | 12-Month Follow-up |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beachwood | Ohio | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28195933 | Derived | Szczotka-Flynn LB, Jiang Y, Stiegemeier MJ, Mutti DO, Walline J, Wilson T, Debanne S; Mucin Ball Study Group. Mucin Balls Influence Corneal Infiltrative Events. Optom Vis Sci. 2017 Apr;94(4):448-457. doi: 10.1097/OPX.0000000000001045. |
Not provided
Not provided
During Phase I, subjects are classified as either repeated Mucin Ball former or Non-Repeat Mucin Ball former. The 227 subjects that entered Phase II kept there Mucin ball classification, but were still randomized to either comfilcon A or balafilcon A. All comparisons are made between Mucin Ball classification
289 Subjects were enrolled in the study. 7 subjects did not meet the eligibility criteria. 282 subjects entered Phase I. During Phase I, 55 subjects were either lost to follow-up or discontinued. The remaining 227 subjects were randomized to either comfilcon A or balafilcon A and entered Phase II. 146 subjects completed Phase II
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Lotrafilcon A | All subjects received lotrafilcon A in Phase I. |
| FG001 | Comfilcon A | Subjects that received comfilcon A lens in Phase II. |
| FG002 | Balfilcon A | Subjects that received balafilcon A lens in Phase II. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase I |
|
| |||||||||||||||||||||
| Phase II |
|
The analysis population consists of all subjects that entered Phase 1.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Overall | The analysis population consists of all subjects that were enrolled into the study. |
| 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 | Corneal Infiltrate Events - Phase I | The percentage of Subjects that experienced Corneal Inflammatory Events within their Mucin Ball classification. | The analysis population consists of subjects that completed all study visits in Phase I without a major protocol deviation and were correctly classified as either repeat Mucin Ball former or Non-repeat Mucin Ball former. Five subjects had incorrect Mucin Ball classification and 8 subjects met study objective. | Posted | Number | percentage of subjects | 1-Month Follow-up |
|
1 year
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 | Comfilcon A | Subjects who received comfilcon A in Phase II of the study. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asymptomatic corneal scar | Eye disorders |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tawnya Wilson, OD Principal Research Optometrist | Johnson &Johnson Vision Care, Inc | 904-443-3500 | 1834 | TWilson@ITS.JNJ.com |
Not provided
| ID | Term |
|---|---|
| D007634 | Keratitis |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| comfilcon A | Device | To be assigned at randomization at phase 2 only. |
|
| balafilcon A | Device | To be assigned at randomization during phase 2 only. |
|
| etafilcon A | Other | Assigned to Neophytes during Phase I for a 2-week period |
|
| Cleveland |
| Ohio |
| United States |
| Columbus | Ohio | United States |
| Study related symptoms/complaints |
|
| Withdrawal by Subject |
|
| NOT COMPLETED |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Subjects that were classified as Non-repeat Mucin Ball Former.
|
|
| Primary | Corneal Infiltrate Event- Phase II | The percentage of Subjects that experienced Corneal Inflammatory Events within their Mucin Ball classification. | The analysis population consists of subjects that were enrolled into Phase II and were correctly classified as either repeat Mucin Ball former or Non-repeat Mucin Ball former. Twenty- three subjects had incorrect Mucin ball classification. | Posted | Number | percentage of subjects | 12-Month Follow-up |
|
|
|
| 0 |
| 115 |
| 30 |
| 115 |
| EG001 | Balafilcon A | Subjects who received balafilcon A in Phase II of the study | 0 | 112 | 24 | 112 |
| EG002 | Lotrafilcon A | All Subjects received lotrafilcon A in Phase I of the study. | 0 | 282 | 23 | 282 |
| Cornea Lens Peripheral Ulcer (CLPU) | Eye disorders |
|
| Conjunctivitis | Eye disorders | Includes Contact lens papillary, viral, bacterial, and allergic |
|
| SEALs | Eye disorders |
|
Not provided