Not provided
Not provided
Not provided
Not provided
Not provided
Study was terminated due to a business decision to cancel the entire project.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this twelve month dispensing study is to evaluate the clinical performance, particularly comfort and vision, of KeraSoft IC Soft Contact Lenses.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KeraSoft IC Soft Contact Lenses | Experimental | KeraSoft IC Soft Contact Lenses, with CIBA Clear Care solution provided for lens care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KeraSoft IC Soft Contact Lenses | Device | Lenses will be worn between 8 and 16 hrs each day, for 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comfort | Symptoms and complaints measured on an analog scale | 4 visits over 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity - Low Contrast | Low contrast visual acuity measured with high ambient illumination (LCHI) | 4 visits over 1 year |
| Visual Acuity - High Contrast | High contrast visual acuity measured with high ambient illumination (HCHI) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert Steffen, OD, MS | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch & Lomb Incorporated | Rochester | New York | 14609 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | KeraSoft IC Soft Contact Lenses | KeraSoft IC Soft Contact Lenses, with CIBA Clear Care solution provided for lens care KeraSoft IC Soft Contact Lenses: Lenses will be worn between 8 and 16 hrs each day, for 12 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | KeraSoft IC Soft Contact Lenses | KeraSoft IC Soft Contact Lenses, with CIBA Clear Care solution provided for lens care KeraSoft IC Soft Contact Lenses: Lenses will be worn between 8 and 16 hrs each day, for 12 months |
| 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 | Comfort | Symptoms and complaints measured on an analog scale | DUE TO THE CANCELLATION OF THIS PROJECT, NO STATISTICAL OR CLINICALLY MEANINGFUL CONCLUSIONS RELATED TO THE STUDY ENDPOINTS WERE MADE. | Posted | 4 visits over 1 year |
|
|
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 | KeraSoft IC Soft Contact Lenses | KeraSoft IC Soft Contact Lenses, with CIBA Clear Care solution provided for lens care KeraSoft IC Soft Contact Lenses: Lenses will be worn between 8 and 16 hrs each day, for 12 months |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Steffen, OD, MS | Bausch & Lomb / Valeant Pharmaceuticals | 585-338-6399 | robert.steffen@bausch.com |
Not provided
| ID | Term |
|---|---|
| D007640 | Keratoconus |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 4 visits over 1 year |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Secondary | Visual Acuity - Low Contrast | Low contrast visual acuity measured with high ambient illumination (LCHI) | DUE TO THE CANCELLATION OF THIS PROJECT, NO STATISTICAL OR CLINICALLY MEANINGFUL CONCLUSIONS RELATED TO THE STUDY ENDPOINTS WERE MADE. | Posted | 4 visits over 1 year |
|
|
| Secondary | Visual Acuity - High Contrast | High contrast visual acuity measured with high ambient illumination (HCHI) | DUE TO THE CANCELLATION OF THIS PROJECT, NO STATISTICAL OR CLINICALLY MEANINGFUL CONCLUSIONS RELATED TO THE STUDY ENDPOINTS WERE MADE. | Posted | 4 visits over 1 year |
|
|
| 0 |
| 12 |
| 0 |
| 12 |
Not provided
Not provided
Not provided