Trial Outcomes & Findings for Treatment of Patients With Blepharitis and Facial Rosacea (NCT NCT00560703)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

70 participants

Primary outcome timeframe

Baseline to Week 12

Results posted on

2021-02-18

Participant Flow

Recruitment time was approximately 6 months in 8 US clinics.

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.

Participant milestones

Participant milestones
Measure	COL-101 (Doxycycline, USP) Capsules 40 MG, Once per day for 84 days	Placebo Sugar capsule, once per day for 84 days
Overall Study STARTED	46	24
Overall Study COMPLETED	46	18
Overall Study NOT COMPLETED	0	6

Reasons for withdrawal

Reasons for withdrawal
Measure	COL-101 (Doxycycline, USP) Capsules 40 MG, Once per day for 84 days	Placebo Sugar capsule, once per day for 84 days
Overall Study Adverse Event	0	2
Overall Study Protocol Violation	0	2
Overall Study Withdrawal by Subject	0	1
Overall Study non-compliance	0	1

Baseline Characteristics

Treatment of Patients With Blepharitis and Facial Rosacea

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	COL-101 (Doxycycline, USP) Capsules n=46 Participants 40 MG, Once per day for 84 days	Placebo n=24 Participants Sugar capsule, once per day for 84 days	Total n=70 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	36 Participants n=5 Participants	15 Participants n=7 Participants	51 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Age, Continuous	54.5 years STANDARD_DEVIATION 13.46 • n=5 Participants	58.2 years STANDARD_DEVIATION 14.27 • n=7 Participants	55.7 years STANDARD_DEVIATION 13.76 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	13 Participants n=7 Participants	43 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	11 Participants n=7 Participants	27 Participants n=5 Participants
Region of Enrollment United States	46 participants n=5 Participants	24 participants n=7 Participants	70 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	COL-101 (Doxycycline, USP) Capsules n=46 Participants 40 MG, Once per day for 84 days	Placebo n=24 Participants Sugar capsule, once per day for 84 days
Change in Bulbar Conjunctival Hyperemia	-0.61 Scores on a scale Standard Deviation 0.797	-0.60 Scores on a scale Standard Deviation 0.707

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	COL-101 (Doxycycline, USP) Capsules n=46 Participants 40 MG, Once per day for 84 days	Placebo n=24 Participants Sugar capsule, once per day for 84 days
Change in Ocular Surface Disease Index (OSDI)	-5.15 Scores on a scale Standard Deviation 14.002	-8.70 Scores on a scale Standard Deviation 17.719

Adverse Events

COL-101 (Doxycycline, USP) Capsules

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	COL-101 (Doxycycline, USP) Capsules n=46 participants at risk 40 MG, Once per day for 84 days	Placebo n=24 participants at risk Sugar capsule, once per day for 84 days
Nervous system disorders Migraine headache	2.2% 1/46 • Number of events 1	0.00% 0/24
Blood and lymphatic system disorders non-hodgkin's lymphoma	0.00% 0/46	4.2% 1/24 • Number of events 1

Other adverse events

Other adverse events
Measure	COL-101 (Doxycycline, USP) Capsules n=46 participants at risk 40 MG, Once per day for 84 days	Placebo n=24 participants at risk Sugar capsule, once per day for 84 days
Nervous system disorders headache	10.9% 5/46 • Number of events 5	0.00% 0/24

Additional Information

Michael Graeber

Organization: Galderma R&D, Inc

Phone: 609-409-7701

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place