Clinical Trials Logo
  1. Home
  2. Dry Eye
  3. NCT00560703
  4. Details
NCT00560703 Clinical Trial

Treatment of Patients With Blepharitis and Facial Rosacea

Dry Eye Clinical Trial

Official title:
Efficacy and Safety of COL-101 for the Treatment of Blepharitis in Patients With Facial Rosacea

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00560703
Other study ID # COL-101-BLEPH-201
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date November 2007
Est. completion date July 2009

Study information
Verified date December 2011
Source Galderma R&D
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date July 2009
Est. primary completion date May 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• COL-101 (doxycycline, USP) capsules
40mg, once per day for 84 days
• placebo
sugar capsule

Locations
Country Name City State
United States Anita Nevyas-Wallace, MD Bala-Cynwyd Pennsylvania
United States Tanner Clinic Layton Utah
United States Pleasant Valley Ophthalmology Little Rock Arkansas
United States Kentucky Lions Eye Center Louisville Kentucky
United States Marguerite McDonald, MD Lynbrook New York
United States Warren Scherer, MD Naples Florida
United States Dean McGee Eye Institute Oklahoma City Oklahoma
United States Washington University School of Medicine Saint Louis Missouri

Sponsors (1)
Lead Sponsor Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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		 Baseline to Week 12
Primary 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).		 Baseline to Week 12
See also
  Status Clinical Trial Phase
Completed NCT05027087 - The Effect of a Novel Blueberry Supplement on Dry Eye Disease Phase 3
Completed NCT06159569 - Performance and Tolerability of the Medical Device LACRIACT N/A
Completed NCT05102409 - An Exploratory Clinical Trial to Assess Safety and Tolerability in Subjects With Dry Eye Disease Phase 2
Completed NCT04081610 - Clinical Trial to Evaluate the Safety and Tolerability of Lagricel® Ofteno Multi-dose Ophthalmic Solution Phase 1
Completed NCT05062564 - Efficacy of LipiFlow in Patients Affected by Meibomian Gland Dysfunction in Reducing Post-cataract Surgery Dry Eye N/A
Completed NCT05825599 - PMCF Study to Evaluate Performance and Safety of "HPMC-based Eyedrops" Used to Relieve Dry Eye Symptoms N/A
Completed NCT03418727 - Dry Eye Disease Study With Brimonidine Phase 2
Active, not recruiting NCT04425551 - Effect of Micropulse Laser on Dry Eye Disease Due to Meibomian Gland Dysfunction N/A
Recruiting NCT04527887 - Intracanalicular Dexamethasone Insert for the Treatment of Inflammation and Discomfort in Dry Eye Disease (DEcIDED) Phase 4
Not yet recruiting NCT06379685 - Study to Evaluate the Safety and Tolerability of PRO-190 Ophthalmic Solution Compared to Systane Ultra® on the Ocular Surface. Phase 1
Active, not recruiting NCT05618730 - Safety, Tolerability, Plug Retention and Preliminary Efficacy of Tacrolimus-loaded Punctal Plug in Patients With Moderate to Severe Dry Eye Disease - Cohort B Phase 1
Completed NCT04553432 - Dry Eye OmniLenz Application of Omnigen Research Study Phase 4
Recruiting NCT04109170 - Dry Eye Evaluation System Based on Bioinformatics
Completed NCT04105842 - Refitting Daily Disposable Contact Lens Wearers With Dry Eye Disease With A Different Daily Disposable Lens Type N/A
Completed NCT05505292 - Lifitegrast 5% for the Treatment of Dry Eye In Habitual Soft Contact Lens Wearers Phase 4
Completed NCT04668131 - Study on Curative Effect and Mechanism of Acupuncture on Neuropathic Pain in Dry Eye Disease N/A
Completed NCT06176651 - Evaluation of Miebo (Perfluorohexyloctane) Eyedrops in Habitual Contact Lens Wearers Phase 4
Not yet recruiting NCT02218827 - Topical Steroid Treatment For Dry Eye N/A
Completed NCT02235259 - Efficacy and Safety of XG-104 for the Treatment of Dry Eye Phase 2
Completed NCT01959854 - Efficacy of Topical 0.2% Xanthan Gum in Patients With Dry Eye N/A