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OpenTrials
Completed

NCT Number: NCT00560703

Treatment of Patients With Blepharitis and 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

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Key information

Conditions

Blepharitis Dry Eye Dry Eye Syndromes Eye Diseases Eyelid Diseases Lacrimal Apparatus Diseases Meibomianitis Meibomitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pleasant Valley Ophthalmology, Little Rock, Arkansas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

COL-101 (doxycycline, USP) capsules

Drug

40mg, once per day for 84 days

Placebo

Drug

sugar capsule

Primary outcomes

  1. 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

  2. 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).

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Nov 20, 2007
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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