Treatment of Patients With Blepharitis and Facial Rosacea

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

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 DiseaseIntervention/TreatmentPhase
  • 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

ArmIntervention/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

SiteCityStateCountryPostal Code
1Pleasant Valley OphthalmologyLittle RockArkansasUnited States72212
2Warren Scherer, MDNaplesFloridaUnited States34103
3Kentucky Lions Eye CenterLouisvilleKentuckyUnited States40202
4Washington University School of MedicineSaint LouisMissouriUnited States63110
5Marguerite McDonald, MDLynbrookNew YorkUnited States11563
6Dean McGee Eye InstituteOklahoma CityOklahomaUnited States73104
7Anita Nevyas-Wallace, MDBala-CynwydPennsylvaniaUnited States19004
8Tanner ClinicLaytonUtahUnited States84041

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:

Study Results

Participant Flow

Recruitment DetailsRecruitment time was approximately 6 months in 8 US clinics.
Pre-assignment DetailSubjects 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 TitleCOL-101 (Doxycycline, USP) CapsulesPlacebo
Arm/Group Description40 MG, Once per day for 84 daysSugar capsule, once per day for 84 days
Period Title: Overall Study
STARTED4624
COMPLETED4618
NOT COMPLETED06

Baseline Characteristics

Arm/Group TitleCOL-101 (Doxycycline, USP) CapsulesPlaceboTotal
Arm/Group Description40 MG, Once per day for 84 daysSugar capsule, once per day for 84 daysTotal of all reporting groups
Overall Participants462470
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
TitleChange in Bulbar Conjunctival Hyperemia
DescriptionBulbar 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 FrameBaseline to Week 12

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleCOL-101 (Doxycycline, USP) CapsulesPlacebo
Arm/Group Description40 MG, Once per day for 84 daysSugar capsule, once per day for 84 days
Measure Participants4624
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 Hypothesisp-Value0.578
Comments
MethodANCOVA
Comments
2. Primary Outcome
TitleChange in Ocular Surface Disease Index (OSDI)
DescriptionOSDI 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 FrameBaseline to Week 12

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleCOL-101 (Doxycycline, USP) CapsulesPlacebo
Arm/Group Description40 MG, Once per day for 84 daysSugar capsule, once per day for 84 days
Measure Participants4624
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 Hypothesisp-Value0.293
Comments
MethodANCOVA
Comments

Adverse Events

Time Frame
Adverse Event Reporting Description
Arm/Group TitleCOL-101 (Doxycycline, USP) CapsulesPlacebo
Arm/Group Description40 MG, Once per day for 84 daysSugar capsule, once per day for 84 days
All Cause Mortality
COL-101 (Doxycycline, USP) CapsulesPlacebo
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total/ (NaN) / (NaN)
Serious Adverse Events
COL-101 (Doxycycline, USP) CapsulesPlacebo
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total1/46 (2.2%) 1/24 (4.2%)
Blood and lymphatic system disorders
non-hodgkin's lymphoma0/46 (0%) 01/24 (4.2%) 1
Nervous system disorders
Migraine headache1/46 (2.2%) 10/24 (0%) 0
Other (Not Including Serious) Adverse Events
COL-101 (Doxycycline, USP) CapsulesPlacebo
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total5/46 (10.9%) 0/24 (0%)
Nervous system disorders
headache5/46 (10.9%) 50/24 (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.

Results Point of Contact

Name/TitleMichael Graeber
OrganizationOrganization: Galderma R&D, Inc
Phone609-409-7701
Emailclinicaltrials@galderma.com
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