Treatment of Patients With Blepharitis and Facial Rosacea

This study has been completed.

Study NCT00560703 Information provided by Galderma

First Received on November 16, 2007. Last Updated on December 9, 2011 History of Changes

Results First Received: April 28, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Blepharitis Meibomianitis Dry Eye
Interventions:	Drug: COL-101 (doxycycline, USP) capsules Drug: placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment time was approximately 6 months in 8 US clinics.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups

	Description
COL-101 (Doxycycline, USP) Capsules	40 MG, Once per day for 84 days
Placebo	Sugar capsule, once per day for 84 days

Participant Flow: Overall Study

	COL-101 (Doxycycline, USP) Capsules	Placebo
STARTED	46	24
COMPLETED	46	18
NOT COMPLETED	0	6
Adverse Event	0	2
Protocol Violation	0	2
Withdrawal by Subject	0	1
non-compliance	0	1

Baseline Characteristics

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Reporting Groups

	Description
COL-101 (Doxycycline, USP) Capsules	40 MG, Once per day for 84 days
Placebo	Sugar capsule, once per day for 84 days

Baseline Measures

	COL-101 (Doxycycline, USP) Capsules	Placebo	Total
Number of Participants [units: participants]	46	24	70
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	36	15	51
>=65 years	10	9	19
Age [units: years] Mean ± Standard Deviation	54.5 ± 13.46	58.2 ± 14.27	55.7 ± 13.76
Gender [units: participants]
Female	30	13	43
Male	16	11	27
Region of Enrollment [units: participants]
United States	46	24	70

Outcome Measures

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1. Primary:

Change in Bulbar Conjunctival Hyperemia [ Time Frame: Baseline to Week 12 ]

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2. Primary:

Change in Ocular Surface Disease Index (OSDI) [ Time Frame: Baseline to Week 12 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Michael Graeber
Organization: Organization: Galderma R&D, Inc
phone: 609-409-7701
e-mail: clinicaltrials@galderma.com

No publications provided

Responsible Party:	Galderma
ClinicalTrials.gov Identifier:	NCT00560703 History of Changes
Other Study ID Numbers:	COL-101-BLEPH-201
Study First Received:	November 16, 2007
Results First Received:	April 28, 2011
Last Updated:	December 9, 2011
Health Authority:	United States: Food and Drug Administration