Treatment of Patients With Blepharitis and Facial Rosacea

• Sponsor: Galderma R&D (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00560703
• Collaborator: (none)
• Enrollment: 70
• Locations: 8
• Arms: 2
• Duration (Months): 20
• Patients Per Site: 8.8
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Blepharitis; Meibomianitis; Dry Eye	Drug: COL-101 (doxycycline, USP) capsules; Drug: placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of COL-101 for the Treatment of Blepharitis in Patients With Facial Rosacea
• Study Start Date: Nov 1, 2007
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: COL-101 (doxycycline, USP) capsules COL-101	Drug: COL-101 (doxycycline, USP) capsules; 40mg, once per day for 84 days
Placebo Comparator: Placebo Sugar capsule	Drug: placebo; sugar capsule

Outcome Measures

Primary Outcome Measures

1. 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

2. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pleasant Valley Ophthalmology	Little Rock	Arkansas	United States	72212
2	Warren Scherer, MD	Naples	Florida	United States	34103
3	Kentucky Lions Eye Center	Louisville	Kentucky	United States	40202
4	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
5	Marguerite McDonald, MD	Lynbrook	New York	United States	11563
6	Dean McGee Eye Institute	Oklahoma City	Oklahoma	United States	73104
7	Anita Nevyas-Wallace, MD	Bala-Cynwyd	Pennsylvania	United States	19004
8	Tanner Clinic	Layton	Utah	United States	84041

Sponsors and Collaborators

• Galderma R&D

Investigators

• Study Director: Michael Graeber, MD, Galderma R&D

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Galderma R&D
• ClinicalTrials.gov Identifier: NCT00560703
• Other Study ID Numbers: COL-101-BLEPH-201
• First Posted: Nov 20, 2007
• Last Update Posted: Feb 18, 2021
• Last Verified: Dec 1, 2011

• Additional relevant MeSH terms: Blepharitis; Rosacea; Doxycycline

Study Results

Participant Flow

Recruitment Details	Recruitment time was approximately 6 months in 8 US clinics.
Pre-assignment Detail	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.

Arm/Group Title	COL-101 (Doxycycline, USP) Capsules	Placebo
Arm/Group Description	40 MG, Once per day for 84 days	Sugar capsule, once per day for 84 days
Period Title: Overall Study
STARTED	46	24
COMPLETED	46	18
NOT COMPLETED	0	6

Baseline Characteristics

Arm/Group Title	COL-101 (Doxycycline, USP) Capsules	Placebo	Total
Arm/Group Description	40 MG, Once per day for 84 days	Sugar capsule, once per day for 84 days	Total of all reporting groups
Overall Participants	46	24	70
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	36 78.3%	15 62.5%	51 72.9%
>=65 years	10 21.7%	9 37.5%	19 27.1%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.5 (13.46)	58.2 (14.27)	55.7 (13.76)
Sex: Female, Male (Count of Participants)
Female	30 65.2%	13 54.2%	43 61.4%
Male	16 34.8%	11 45.8%	27 38.6%
Region of Enrollment (participants) [Number]
United States	46 100%	24 100%	70 100%

Outcome Measures

1. Primary Outcome

Title	Change in Bulbar Conjunctival Hyperemia
Description	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
Time Frame	Baseline to Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	COL-101 (Doxycycline, USP) Capsules	Placebo
Arm/Group Description	40 MG, Once per day for 84 days	Sugar capsule, once per day for 84 days
Measure Participants	46	24
Mean (Standard Deviation) [Scores on a scale]	-0.61 (0.797)	-0.60 (0.707)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	COL-101 (Doxycycline, USP) Capsules, Placebo
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence (legacy)
	Comments	Power calculation for this endpoint was driven by the assumptions made for the OSDI analysis
Statistical Test of Hypothesis	p-Value	0.578
	Comments
	Method	ANCOVA
	Comments

2. Primary Outcome

Title	Change in Ocular Surface Disease Index (OSDI)
Description	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).
Time Frame	Baseline to Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	COL-101 (Doxycycline, USP) Capsules	Placebo
Arm/Group Description	40 MG, Once per day for 84 days	Sugar capsule, once per day for 84 days
Measure Participants	46	24
Mean (Standard Deviation) [Scores on a scale]	-5.15 (14.002)	-8.70 (17.719)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	COL-101 (Doxycycline, USP) Capsules, Placebo
	Comments	It was anticipated that the difference between the treatment groups in mean reduction from baseline in OSDI scores will be approximately 7 points. A pooled standard deviation of 9.0 for the mean change from baseline OSDI score is expected. Under those assumptions a total of approximately 63 evaluable patients (42 COL-101 patients and 21 placebo patients) is sufficient to provide 80% power. The planned enrolment should provide enough evaluable patients to meet these assumptions.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.293
	Comments
	Method	ANCOVA
	Comments

Adverse Events

Arm/Group Title	COL-101 (Doxycycline, USP) Capsules		Placebo
Arm/Group Description	40 MG, Once per day for 84 days		Sugar capsule, once per day for 84 days
All Cause Mortality
	COL-101 (Doxycycline, USP) Capsules		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	COL-101 (Doxycycline, USP) Capsules		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/46 (2.2%)		1/24 (4.2%)
Blood and lymphatic system disorders
non-hodgkin's lymphoma	0/46 (0%)	0	1/24 (4.2%)	1
Nervous system disorders
Migraine headache	1/46 (2.2%)	1	0/24 (0%)	0
Other (Not Including Serious) Adverse Events
	COL-101 (Doxycycline, USP) Capsules		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/46 (10.9%)		0/24 (0%)
Nervous system disorders
headache	5/46 (10.9%)	5	0/24 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.