Topical IL-1-Ra for Treatment of Posterior Blepharitis
|ClinicalTrials.gov Identifier: NCT00681109|
Recruitment Status : Completed
First Posted : May 21, 2008
Results First Posted : November 27, 2012
Last Update Posted : January 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Posterior Blepharitis||Drug: 2.5% IL-1Ra Drug: Placebo Drug: 5% IL-1Ra||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Safety and Efficacy of Topical Interleukin-1-Receptor Antagonist in the Treatment of Signs and Symptoms of Posterior Blepharitis|
|Study Start Date :||January 2008|
|Primary Completion Date :||May 2010|
|Study Completion Date :||October 2010|
Active Comparator: Treatment Arm 1
Drug: 2.5% IL-1Ra
2.5% custom made topical IL-1Ra three times a day in both eyes for three months
Placebo Comparator: Placebo
custom eye drop to be applied three times a day in both eyes for three months
Other Name: Artificial Tear
Active Comparator: Treatment Arm 2
Drug: 5% IL-1Ra
5% custom made topical IL-1Ra to both eyes 3 times a day for 3 months
- Meibomian Gland Secretion Quality [ Time Frame: 12 Week Time Point ]Meibomian Gland Secretion Quality has a range of 0 (normal secretion quality) to 3 (abnormal secretion quality)
- Tear Breakup Time (TBUT) [ Time Frame: 12 Week Time Point ]TBUT measures the amount of time, in seconds, that the tear film completely coats the ocular surface after each blink. The longer the time the tear film completely coats the ocular surface is considered to be better than a shorter amount of time.
- Corneal Fluorescein Staining Score [ Time Frame: 12 Week Time Point ]Is used to assess the level of corneal epitheliopathy that is related to dry eye disease. The CFS scale ranges from 0 to 15 scale, with 0 representing the minimum level of corneal epitheliopathy and 15 representing the maximum level of epitheliopathy.
- Ocular Surface Disease Index (OSDI) [ Time Frame: Baseline and 12 Week Time Point data ]
The Ocular Surface Disease Index (OSDI) is a 12-item questionnaire designed to provide a rapid assessment of the symptoms of ocular irritation consistent with dry eye disease and their impact on vision-related functioning. The 12 items of the OSDI questionnaire are graded on a scale of 0 to 4, where 0 indicates none of the time; 1, some of the time; 2, half of the time; 3, most of the time; and 4, all of the time. The total OSDI score is then calculated on the basis of the following formula: OSDI=[(sum of scores for all questions answered) x 100]/[(total number of questions answered) x 4].
Thus, the OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. A negative change from baseline indicated an improvement in vision-related functioning.
OSDI was assessed on the Baseline Visit, Week 2, Week 6, Week 12, Week 16. Change indicated represents change from Baseline to Week 12.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00681109
|Principal Investigator:||Reza Dana, MD, MPH, MSc||Massachusetts Eye and Ear Infirmary|