Treatment of Patients With Blepharitis and Facial Rosacea

Galderma

Status and phase: Completed; Phase 2

Conditions: Blepharitis; Meibomianitis; Dry Eye

Treatments: Drug: COL-101 (doxycycline, USP) capsules; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00560703

COL-101-BLEPH-201

Details and patient eligibility

About

To determine the safety and efficacy of sub-antimicrobial dose COL-101 in the treatment of patients who have both blepharitis and facial rosacea

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

70 participants in 2 patient groups, including a placebo group

COL-101 (doxycycline, USP) capsules

Active Comparator group

Description:

COL-101

Treatment:

Drug: COL-101 (doxycycline, USP) capsules

Placebo

Placebo Comparator group

Description:

Sugar capsule

Treatment:

Drug: placebo