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
To determine the safety and efficacy of sub-antimicrobial dose COL-101 in the treatment of patients who have both blepharitis and facial rosacea
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COL-101 (doxycycline, USP) capsules | Active Comparator | COL-101 |
|
| Placebo | Placebo Comparator | Sugar capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COL-101 (doxycycline, USP) capsules | Drug | 40mg, once per day for 84 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Bulbar Conjunctival Hyperemia | Bulbar conjunctival hyperemia will be assessed using an ordered categorical value ranging from 0 (Clear) to 4 (Severe). Hyperemia is graded on the following scale and half scores are acceptable: None (0) = normal Mild (1) = slight localized injection Moderate (2) = pink color Severe (3) = red color Very Severe (4) = marked dark redness | Baseline to Week 12 |
| Change in Ocular Surface Disease Index (OSDI) | OSDI is calculated based following formula using 12-question Ocular Surface Disease questionnaire (with each question scored 0-4): OSDI = (D/E)x25, where D = Sum of all scores for questions answered E = Total number of questions answered (not including questions answered NA) Range of OSDI is 0 to 100 (higher score indicates worse condition). | Baseline to Week 12 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael Graeber, MD | Galderma R&D | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pleasant Valley Ophthalmology | Little Rock | Arkansas | 72212 | United States | ||
| Warren Scherer, MD |
Subjects were screened for eligibility within 6 weeks prior to the baseline visit. This 12-week study employed a two-treatment, parallel-group design with subjects randomized in a 2:1 ratio to active drug or placebo.
Recruitment time was approximately 6 months in 8 US clinics.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | COL-101 (Doxycycline, USP) Capsules | 40 MG, Once per day for 84 days |
| FG001 | Placebo | Sugar capsule, once per day for 84 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | COL-101 (Doxycycline, USP) Capsules | 40 MG, Once per day for 84 days |
| BG001 | Placebo | Sugar capsule, once per day for 84 days |
| 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 | Change in Bulbar Conjunctival Hyperemia | Bulbar conjunctival hyperemia will be assessed using an ordered categorical value ranging from 0 (Clear) to 4 (Severe). Hyperemia is graded on the following scale and half scores are acceptable: None (0) = normal Mild (1) = slight localized injection Moderate (2) = pink color Severe (3) = red color Very Severe (4) = marked dark redness | Posted | Apr 2011 | Mean | Standard Deviation | Scores on a scale | Baseline to Week 12 |
|
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 | COL-101 (Doxycycline, USP) Capsules | 40 MG, Once per day for 84 days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Migraine headache | Nervous system disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| headache | Nervous system disorders |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Graeber | Organization: Galderma R&D, Inc | 609-409-7701 | clinicaltrials@galderma.com |
Not provided
| ID | Term |
|---|---|
| D001762 | Blepharitis |
| D000092663 | Meibomitis |
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
| D007766 | Lacrimal Apparatus Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004318 | Doxycycline |
| D002214 | Capsules |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo | Drug | sugar capsule |
|
| Naples |
| Florida |
| 34103 |
| United States |
| Kentucky Lions Eye Center | Louisville | Kentucky | 40202 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Marguerite McDonald, MD | Lynbrook | New York | 11563 | United States |
| Dean McGee Eye Institute | Oklahoma City | Oklahoma | 73104 | United States |
| Anita Nevyas-Wallace, MD | Bala-Cynwyd | Pennsylvania | 19004 | United States |
| Tanner Clinic | Layton | Utah | 84041 | United States |
| Withdrawal by Subject |
|
| non-compliance |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | Change in Ocular Surface Disease Index (OSDI) | OSDI is calculated based following formula using 12-question Ocular Surface Disease questionnaire (with each question scored 0-4): OSDI = (D/E)x25, where D = Sum of all scores for questions answered E = Total number of questions answered (not including questions answered NA) Range of OSDI is 0 to 100 (higher score indicates worse condition). | Posted | Mean | Standard Deviation | Scores on a scale | Baseline to Week 12 |
|
|
|
|
| 1 |
| 46 |
| 5 |
| 46 |
| EG001 | Placebo | Sugar capsule, once per day for 84 days | 1 | 24 | 0 | 24 |
| non-hodgkin's lymphoma | Blood and lymphatic system disorders |
|
Not provided
Not provided
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |