Trial Outcomes & Findings for Topical IL-1-Ra for Treatment of Posterior Blepharitis (NCT NCT00681109)

NCT ID: NCT00681109

Last Updated: 2018-01-19

Results Overview

Meibomian Gland Secretion Quality has a range of 0 (normal secretion quality) to 3 (abnormal secretion quality)

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

75 participants

Primary outcome timeframe

12 Week Time Point

Results posted on

2018-01-19

Participant Flow

Participant milestones

Participant milestones
Measure	2.5% IL-1Ra Anakinra (IL-1Ra) 2.5% Topical Ophthalmic Solution three times per day.	Placebo Artificial Tear Topical Ophthalmic Solution three times per day.	5% IL-1Ra Anakinra (IL-1Ra) 5% Topical Ophthalmic Solution three times per day.
Overall Study STARTED	30	30	15
Overall Study COMPLETED	28	24	15
Overall Study NOT COMPLETED	2	6	0

Reasons for withdrawal

Reasons for withdrawal
Measure	2.5% IL-1Ra Anakinra (IL-1Ra) 2.5% Topical Ophthalmic Solution three times per day.	Placebo Artificial Tear Topical Ophthalmic Solution three times per day.	5% IL-1Ra Anakinra (IL-1Ra) 5% Topical Ophthalmic Solution three times per day.
Overall Study Lost to Follow-up	2	6	0

Baseline Characteristics

Topical IL-1-Ra for Treatment of Posterior Blepharitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	2.5% IL-1Ra n=30 Participants Anakinra 2.5% Topical Ophthalmic Solution	Placebo n=30 Participants Artificial Tear Topical Ophthalmic Solution	5% IL-1Ra n=15 Participants Anakinra 5% Topical Ophthalmic Solution	Total n=75 Participants Total of all reporting groups
Age, Continuous	49 years STANDARD_DEVIATION 14 • n=5 Participants	53 years STANDARD_DEVIATION 12 • n=7 Participants	58 years STANDARD_DEVIATION 16 • n=5 Participants	52 years STANDARD_DEVIATION 14 • n=4 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	16 Participants n=7 Participants	10 Participants n=5 Participants	44 Participants n=4 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	14 Participants n=7 Participants	5 Participants n=5 Participants	31 Participants n=4 Participants
Region of Enrollment United States	30 participants n=5 Participants	30 participants n=7 Participants	15 participants n=5 Participants	75 participants n=4 Participants
Meibomian Gland Secretion Quality	1.9 units on a scale STANDARD_DEVIATION 0.4 • n=5 Participants	1.8 units on a scale STANDARD_DEVIATION 0.5 • n=7 Participants	1.9 units on a scale STANDARD_DEVIATION 0.5 • n=5 Participants	1.9 units on a scale STANDARD_DEVIATION 0.5 • n=4 Participants
Tear Film Break-Up Time (TBUT)	3.8 Seconds STANDARD_DEVIATION 2.8 • n=5 Participants	3.8 Seconds STANDARD_DEVIATION 2.1 • n=7 Participants	3.5 Seconds STANDARD_DEVIATION 2.2 • n=5 Participants	3.7 Seconds STANDARD_DEVIATION 2.5 • n=4 Participants
Corneal Fluorescein Staining Score	1.6 units on a scale STANDARD_DEVIATION 0.9 • n=5 Participants	1.7 units on a scale STANDARD_DEVIATION 1.2 • n=7 Participants	1.7 units on a scale STANDARD_DEVIATION 0.9 • n=5 Participants	1.7 units on a scale STANDARD_DEVIATION 1.0 • n=4 Participants
Ocular Surface Disease Index (OSDI)	44.2 units on a scale STANDARD_DEVIATION 20.4 • n=5 Participants	45.6 units on a scale STANDARD_DEVIATION 21.1 • n=7 Participants	48.5 units on a scale STANDARD_DEVIATION 21.0 • n=5 Participants	46.1 units on a scale STANDARD_DEVIATION 20.4 • n=4 Participants

PRIMARY outcome

Timeframe: 12 Week Time Point

Meibomian Gland Secretion Quality has a range of 0 (normal secretion quality) to 3 (abnormal secretion quality)

Outcome measures

Outcome measures
Measure	2.5% IL-1Ra n=30 Participants Anakinra (IL-1Ra) 2.5% Topical Ophthalmic Solution three times per day.	Placebo n=30 Participants Artificial Tear Topical Ophthalmic Solution three times per day.	5% IL-1Ra n=15 Participants Anakinra (IL-1Ra) 5% Topical Ophthalmic Solution three times per day.
Meibomian Gland Secretion Quality	1.7 Units on a scale Standard Deviation 0.7	1.7 Units on a scale Standard Deviation 0.4	1.8 Units on a scale Standard Deviation 0.6

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	2.5% IL-1Ra n=30 Participants Anakinra (IL-1Ra) 2.5% Topical Ophthalmic Solution three times per day.	Placebo n=30 Participants Artificial Tear Topical Ophthalmic Solution three times per day.	5% IL-1Ra n=15 Participants Anakinra (IL-1Ra) 5% Topical Ophthalmic Solution three times per day.
Tear Breakup Time (TBUT)	4.5 Seconds Standard Deviation 2.8	4.4 Seconds Standard Deviation 2.3	3.9 Seconds Standard Deviation 2.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	2.5% IL-1Ra n=30 Participants Anakinra (IL-1Ra) 2.5% Topical Ophthalmic Solution three times per day.	Placebo n=30 Participants Artificial Tear Topical Ophthalmic Solution three times per day.	5% IL-1Ra n=15 Participants Anakinra (IL-1Ra) 5% Topical Ophthalmic Solution three times per day.
Corneal Fluorescein Staining Score	0.9 Units on a scale Standard Deviation 0.7	1.4 Units on a scale Standard Deviation 1.1	1.4 Units on a scale Standard Deviation 0.8

PRIMARY outcome

Timeframe: Baseline and 12 Week Time Point data

Population: The OSDI analysis for this study is based on a standard intention-to-treat analysis with each study participant analyzed with respect to the randomized treatment assignment, regardless of eventual compliance.

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.

Outcome measures

Outcome measures
Measure	2.5% IL-1Ra n=30 Participants Anakinra (IL-1Ra) 2.5% Topical Ophthalmic Solution three times per day.	Placebo n=30 Participants Artificial Tear Topical Ophthalmic Solution three times per day.	5% IL-1Ra n=15 Participants Anakinra (IL-1Ra) 5% Topical Ophthalmic Solution three times per day.
Ocular Surface Disease Index (OSDI)	31.8 units on a scale Standard Deviation 24.1	41.8 units on a scale Standard Deviation 24.1	31.7 units on a scale Standard Deviation 19.0

Adverse Events

2.5% IL-1Ra

Serious events: 1 serious events

Other events: 11 other events

Deaths: 1 deaths

Placebo

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

5% IL-1Ra

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	2.5% IL-1Ra n=30 participants at risk Anakinra 2.5% Topical Ophthalmic Solution	Placebo n=30 participants at risk Artificial Tear Topical Ophthalmic Solution	5% IL-1Ra n=15 participants at risk Anakinra 5% Topical Ophthalmic Solution
Blood and lymphatic system disorders Death	3.3% 1/30 • Number of events 1 • 16 Weeks	0.00% 0/30 • 16 Weeks	0.00% 0/15 • 16 Weeks

Other adverse events

Other adverse events
Measure	2.5% IL-1Ra n=30 participants at risk Anakinra 2.5% Topical Ophthalmic Solution	Placebo n=30 participants at risk Artificial Tear Topical Ophthalmic Solution	5% IL-1Ra n=15 participants at risk Anakinra 5% Topical Ophthalmic Solution
Eye disorders Stinging Eye	3.3% 1/30 • Number of events 1 • 16 Weeks	3.3% 1/30 • Number of events 1 • 16 Weeks	0.00% 0/15 • 16 Weeks
Eye disorders Burning Eye	3.3% 1/30 • Number of events 1 • 16 Weeks	10.0% 3/30 • Number of events 3 • 16 Weeks	0.00% 0/15 • 16 Weeks
Eye disorders Grittiness	10.0% 3/30 • Number of events 3 • 16 Weeks	0.00% 0/30 • 16 Weeks	0.00% 0/15 • 16 Weeks
Eye disorders Itching Eye	3.3% 1/30 • Number of events 1 • 16 Weeks	3.3% 1/30 • Number of events 1 • 16 Weeks	0.00% 0/15 • 16 Weeks
Eye disorders Blurred Vision	6.7% 2/30 • Number of events 2 • 16 Weeks	6.7% 2/30 • Number of events 2 • 16 Weeks	6.7% 1/15 • Number of events 1 • 16 Weeks
Eye disorders Epiphora	0.00% 0/30 • 16 Weeks	3.3% 1/30 • Number of events 1 • 16 Weeks	0.00% 0/15 • 16 Weeks
Eye disorders Discomfort (unspecific)	0.00% 0/30 • 16 Weeks	6.7% 2/30 • Number of events 2 • 16 Weeks	0.00% 0/15 • 16 Weeks
Eye disorders Eyelid Irritation	3.3% 1/30 • Number of events 1 • 16 Weeks	6.7% 2/30 • Number of events 2 • 16 Weeks	0.00% 0/15 • 16 Weeks
Eye disorders Pingueculitis	0.00% 0/30 • 16 Weeks	6.7% 2/30 • Number of events 2 • 16 Weeks	0.00% 0/15 • 16 Weeks
Eye disorders Blepharospasm	0.00% 0/30 • 16 Weeks	6.7% 2/30 • Number of events 2 • 16 Weeks	0.00% 0/15 • 16 Weeks
Eye disorders Episcleritis	3.3% 1/30 • Number of events 1 • 16 Weeks	0.00% 0/30 • 16 Weeks	0.00% 0/15 • 16 Weeks
Eye disorders Conjunctivitis	3.3% 1/30 • Number of events 1 • 16 Weeks	3.3% 1/30 • Number of events 1 • 16 Weeks	6.7% 1/15 • Number of events 1 • 16 Weeks

Additional Information

Dr. Reza Dana

Massachusetts Eye and Ear Infirmary

Phone: (617) 573-4331

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place