A Phase 2 interventional study of COL-101 (doxycycline, USP) capsules and placebo in Blepharitis, Meibomianitis and Dry Eye, sponsored by Galderma R&D. Completed at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-18.
Sponsored by Galderma R&D · Phase 2, Interventional, and Treatment
To determine the safety and efficacy of sub-antimicrobial dose COL-101 in the treatment of patients who have both blepharitis and facial rosacea
Exclusion Criteria:
COL-101
Drug: COL-101 (doxycycline, USP) capsules
Sugar capsule
Drug: placebo
40mg, once per day for 84 days
sugar capsule
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
Time frame: 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).
Time frame: Baseline to Week 12
Recruitment time was approximately 6 months in 8 US clinics.
| Milestone | COL-101 (Doxycycline, USP) Capsules | Placebo |
|---|---|---|
| Started | 46 | 24 |
| Completed | 46 | 18 |
| Not completed | 0 | 6 |
| Withdrew: Adverse event | 0 | 2 |
| Withdrew: Protocol violation | 0 | 2 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Non-compliance | 0 | 1 |
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
| Scores on a scale | COL-101 (Doxycycline, USP) Capsules | Placebo |
|---|---|---|
| Change in Bulbar Conjunctival Hyperemia | -0.61 ± 0.797 | -0.60 ± 0.707 |
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).
| Scores on a scale | COL-101 (Doxycycline, USP) Capsules | Placebo |
|---|---|---|
| Change in Ocular Surface Disease Index (OSDI) | -5.15 ± 14.002 | -8.70 ± 17.719 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| COL-101 (Doxycycline, USP) Capsules | — | 1/46 (2.2%) | 5/46 (10.9%) |
| Placebo | — | 1/24 (4.2%) | 0/24 (0%) |
| Event | COL-101 (Doxycycline, USP) Capsules | Placebo |
|---|---|---|
| non-hodgkin's lymphomaBlood and lymphatic system disorders | 0/46 | 1/24 |
| Migraine headacheNervous system disorders | 1/46 | 0/24 |
| Event | COL-101 (Doxycycline, USP) Capsules | Placebo |
|---|---|---|
| headacheNervous system disorders | 5/46 | 0/24 |
| Age, Categorical(Participants) | COL-101 (Doxycycline, USP) Capsules | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 36 | 15 | 51 |
| >=65 years | 10 | 9 | 19 |
| Age, Continuous(years) | COL-101 (Doxycycline, USP) Capsules | Placebo | Total |
|---|---|---|---|
| Mean | 54.5 ± 13.46 | 58.2 ± 14.27 | 55.7 ± 13.76 |
| Sex: Female, Male(Participants) | COL-101 (Doxycycline, USP) Capsules | Placebo | Total |
|---|---|---|---|
| Female | 30 | 13 | 43 |
| Male | 16 | 11 | 27 |
| Region of Enrollment(participants) | COL-101 (Doxycycline, USP) Capsules | Placebo | Total |
|---|---|---|---|
| United States | 46 | 24 | 70 |
This study is completed, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.
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Galderma R&D