Trial · NCT00560703
Treatment of Patients With Blepharitis and Facial Rosacea
NCT00560703, Phase 2, Completed, Galderma R&D; results first posted 2012-01-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treatment of Patients With Blepharitis and Facial Rosacea. Trials, record NCT00560703. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00560703
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Patients With Blepharitis and Facial Rosacea
- NCT number
- NCT00560703
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 70 participants, actual
- Lead sponsor
- Galderma R&D
- Conditions
- Blepharitis, Meibomianitis, Dry Eye
- Interventions
- COL-101 (doxycycline, USP) capsules, placebo
- First posted
- 2007-11-20
- Last updated
- 2021-02-18
- Results first posted
- 2012-01-11
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Bulbar Conjunctival Hyperemia | Baseline to Week 12 | 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 |
| Primary | Change in Ocular Surface Disease Index (OSDI) | Baseline to Week 12 | 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). |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Bulbar Conjunctival Hyperemia | Baseline to Week 12 | Scores on a scale | MEAN | |
| PRIMARY | Change in Ocular Surface Disease Index (OSDI) | Baseline to Week 12 | Scores on a scale | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Bulbar Conjunctival Hyperemia | COL-101 (Doxycycline, USP) Capsules | -0.61 | Standard Deviation 0.797 | Scores on a scale | |
| Change in Bulbar Conjunctival Hyperemia | Placebo | -0.60 | Standard Deviation 0.707 | Scores on a scale | |
| Change in Ocular Surface Disease Index (OSDI) | COL-101 (Doxycycline, USP) Capsules | -5.15 | Standard Deviation 14.002 | Scores on a scale | |
| Change in Ocular Surface Disease Index (OSDI) | Placebo | -8.70 | Standard Deviation 17.719 | Scores on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | COL-101 (Doxycycline, USP) Capsules | 46 | |
| Overall Study | STARTED | Placebo | 24 | |
| Overall Study | COMPLETED | COL-101 (Doxycycline, USP) Capsules | 46 | |
| Overall Study | COMPLETED | Placebo | 18 | |
| Overall Study | NOT COMPLETED | COL-101 (Doxycycline, USP) Capsules | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 6 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | headache | Nervous system disorders | COL-101 (Doxycycline, USP) Capsules | 5 | 46 | 5 |
| other | headache | Nervous system disorders | Placebo | 0 | 24 | 0 |
| serious | Migraine headache | Nervous system disorders | COL-101 (Doxycycline, USP) Capsules | 1 | 46 | 1 |
| serious | Migraine headache | Nervous system disorders | Placebo | 0 | 24 | 0 |
| serious | non-hodgkin's lymphoma | Blood and lymphatic system disorders | COL-101 (Doxycycline, USP) Capsules | 0 | 46 | 0 |
| serious | non-hodgkin's lymphoma | Blood and lymphatic system disorders | Placebo | 1 | 24 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | COL-101 (Doxycycline, USP) Capsules | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | COL-101 (Doxycycline, USP) Capsules | 5 | 46 |
| Total, other adverse events | Placebo | 0 | 24 |
| Total, serious adverse events | COL-101 (Doxycycline, USP) Capsules | 1 | 46 |
| Total, serious adverse events | Placebo | 1 | 24 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| COL-101 (Doxycycline, USP) Capsules vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00560703
GET https://conductscience.org/api/trials/v1/NCT00560703/registered