Systemic Bioavailability Study Of Col-118 Administered Topically as a 0.18 % Facial Gel And Brimonidine Ophthalmic Solution 0.2%
Condition: Erythematous Rosacea
MeSH terms: Rosacea
Intervention: 0.18% COL-118 facial gel (1.8 mg brimonidine); 0.2% brimonidine ophthalmic solution (0.1 mg brimonidine tartrate/drop); Advanced Eye Relief; COL-118 facial gel vehicle
Intervention description: One 1-g application of 0.18% COL-118 facial gel (1.8 mg brimonidine) administered topically plus one drop of Advanced Eye Relief™ in each eye, once in the morning. 1 g of 0.18% COL-118 facial gel is reapplied once after 4 hours; One 1-g application of COL-118 facial gel vehicle (0.0 mg brimonidine tartrate) topically plus one drop of 0.2% brimonidine ophthalmic solution (0.1 mg brimonidine tartrate/drop) in each eye. Four hours after the first application 1-g of COL-118 facial gel vehicle (0.0 mg brimonidine) is administered topically.; One 1-g application of 0.18% COL-118 facial gel (1.8 mg brimonidine) administered topically plus one drop of Advanced Eye Relief™ in each eye, once in the morning. 1 g of 0.18% COL-118 facial gel is reapplied once after 4 hours; One 1-g application of COL-118 facial gel vehicle (0.0 mg brimonidine tartrate) administered topically plus one drop of 0.2% brimonidine ophthalmic solution (0.1 mg brimonidine tartrate/drop) in each eye. Four hours after the first application 1-g of COL-118 facial gel vehicle (0.0 mg brimonidine) is administered topically
Intervention MeSH terms: Brimonidine Tartrate; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: erythematous rosacea; facial gel; brimonidine; ophthalmic solution

Summary:

      Phase II systemic bioavailability crossover study to measure the exposure of Col-118 topical
      0.18 % Facial Gel and Brimonidine Ophthalmic Solution 0.2%
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female ≥18 years of age

          -  Clinical diagnosis of rosacea

          -  A score of ≥ 3 on the CEAS

          -  A score of ≥ 3 on the PSA

          -  IOP ≥ 10 mm Hg

          -  Non-pregnant and non-lactating females

        Exclusion Criteria:

          -  History of hypersensitivity or allergies to any ingredient of the study drugs, unless
             approved by the Investigator

          -  Use of brimonidine prescription medications within 14 days prior to Check-in

          -  Use of any over-the-counter (OTC), non-prescription preparations (including vitamins,
             minerals, and phytotherapeutic/herbal/plant-derived preparations) within 7 days prior
             to Check-in, unless deemed acceptable by the Investigator

          -  Use of systemic or topical steroids applied to the face 14 days prior to Check in

          -  The use of any Rx or OTC products for the treatment of acne or rosacea within 14 days
             prior to check in

          -  The use of isotretinoin within 180 days prior to check in