BlepharitisPhase 2NCT00560703
Treatment of Patients With Blepharitis and Facial Rosacea
A Phase 2 study testing COL-101 (doxycycline, USP) capsules in people with Blepharitis and Meibomianitis, run by Galderma R&D at 8 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blepharitis, Meibomianitis, Dry Eye
- What is being tested?
- COL-101 (doxycycline, USP) capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 8 sitesUnited States
- Study dates
- Nov 2007to Jul 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- blepharitis
- facial rosacea
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Anita Nevyas-Wallace, MD
Bala-Cynwyd, Pennsylvania, 19004
Tanner Clinic
Layton, Utah, 84041
Pleasant Valley Ophthalmology
Little Rock, Arkansas, 72212
Kentucky Lions Eye Center
Louisville, Kentucky, 40202
Marguerite McDonald, MD
Lynbrook, New York, 11563
Warren Scherer, MD
Naples, Florida, 34103
Dean McGee Eye Institute
Oklahoma City, Oklahoma, 73104
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Efficacy and Safety of COL-101 for the Treatment of Blepharitis in Patients With Facial Rosacea
To determine the safety and efficacy of sub-antimicrobial dose COL-101 in the treatment of patients who have both blepharitis and facial rosacea
- Conditions
- Blepharitis, Meibomianitis, Dry Eye
- Being tested
- COL-101 (doxycycline, USP) capsules, placebo
- Medical subject headings
- Blepharitis, Meibomitis, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COL-101 (doxycycline, USP) capsulesDrug
40mg, once per day for 84 days
placeboDrug
sugar capsule
| Study group | Role | What they receive |
|---|---|---|
| COL-101 (doxycycline, USP) capsules | Active comparator | COL-101 Receives: Drug: COL-101 (doxycycline, USP) capsules |
| Placebo | Placebo comparator | Sugar capsule Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Bulbar Conjunctival Hyperemia
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
Measured: Baseline to Week 12
Change in Ocular Surface Disease Index (OSDI)
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).
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionMay 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BlepharitisStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Graeber, MD, Study director, Galderma R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00560703
- Sponsor's protocol ID
- COL-101-BLEPH-201
- Status last verified
- Dec 2011
- First submitted
- 16 Nov 2007
- Last updated
- 18 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of COL-101 for the Treatment of Blepharitis in Patients With Facial Rosacea
- ClinicalTrials.gov ID
- NCT00560703
- Acronym / sponsor ID
- COL-101-BLEPH-201
- Conditions
- Blepharitis, Meibomianitis, Dry Eye
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- May 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 20 Nov 2007 (estimated)
- Results
- Posted 11 Jan 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the safety and efficacy of sub-antimicrobial dose COL-101 in the treatment of patients who have both blepharitis and facial rosacea
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COL-101 (doxycycline, USP) capsules | Active comparator | Drug: COL-101 (doxycycline, USP) capsulesCOL-101 |
| Placebo | Placebo comparator | Drug: placeboSugar capsule |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- blepharitis
- facial rosacea
Key exclusion criteria (6 listed)
- pregnant or nursing women
- allergy to tetracyclines
- recent eye surgery
- past or current use of isotretinoin
- patients who are achlorhydric
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COL-101 (doxycycline, USP) capsules40mg, once per day for 84 days | Drug | COL-101 (doxycycline, USP) capsules |
| placebosugar capsule | Drug | Placebo |
Primary outcome
Change in Bulbar Conjunctival Hyperemia
Time frame: 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
Change in Ocular Surface Disease Index (OSDI)
Time frame: 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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Graeber, MD study director
Galderma R&D
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing COL-101 (doxycycline, USP) capsules in people with Blepharitis and Meibomianitis, run by Galderma R&D at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Bulbar Conjunctival Hyperemia (time frame: Baseline to Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.