Phase 2
N=70
Treatment of Patients With Blepharitis and Facial Rosacea
Blepharitis · Meibomianitis · Dry Eye
Bottom Line
View on ClinicalTrials.gov: NCT00560703 ↗Enrolled (actual)
70
Serious AEs
2.9%
Results posted
Jan 2012
Primary outcome: Primary: Change in Bulbar Conjunctival Hyperemia — -0.61; -0.60 Scores on a scale — p=0.578
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- COL-101 (doxycycline, USP) capsules (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Bulbar Conjunctival Hyperemia |
-0.61; -0.60 | 0.578 |
| PRIMARY Change in Ocular Surface Disease Index (OSDI) |
-5.15; -8.70 | 0.293 |
Summary
To determine the safety and efficacy of sub-antimicrobial dose COL-101 in the treatment of patients who have both blepharitis and facial rosacea
Eligibility Criteria
Inclusion Criteria
- blepharitis
- facial rosacea
Exclusion Criteria
- pregnant or nursing women
- allergy to tetracyclines
- recent eye surgery
- past or current use of isotretinoin
- patients who are achlorhydric
- patients who have had gastric by-pass surgery
Data sourced from ClinicalTrials.gov (NCT00560703). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.