Trial · NCT00681109

Topical IL-1-Ra for Treatment of Posterior Blepharitis

NCT00681109, Phase 1, Phase 2, Completed, Reza Dana, MD; results first posted 2012-11-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Topical IL-1-Ra for Treatment of Posterior Blepharitis. Trials, record NCT00681109. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00681109

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Topical IL-1-Ra for Treatment of Posterior Blepharitis
NCT number: NCT00681109
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 75 participants, actual
Lead sponsor: Reza Dana, MD
Conditions: Posterior Blepharitis
Interventions: 2.5% IL-1Ra, Placebo, 5% IL-1Ra
First posted: 2008-05-21
Last updated: 2018-01-19
Results first posted: 2012-11-27

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Meibomian Gland Secretion Quality	12 Week Time Point	Meibomian Gland Secretion Quality has a range of 0 (normal secretion quality) to 3 (abnormal secretion quality)
Primary	Tear Breakup Time (TBUT)	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.
Primary	Corneal Fluorescein Staining Score	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.
Primary	Ocular Surface Disease Index (OSDI)	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.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Meibomian Gland Secretion Quality	12 Week Time Point		Units on a scale	MEAN
PRIMARY	Tear Breakup Time (TBUT)	12 Week Time Point		Seconds	MEAN
PRIMARY	Corneal Fluorescein Staining Score	12 Week Time Point		Units on a scale	MEAN
PRIMARY	Ocular Surface Disease Index (OSDI)	Baseline and 12 Week Time Point data	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.	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Meibomian Gland Secretion Quality	2.5% IL-1Ra	1.7	Standard Deviation 0.7	Units on a scale
Meibomian Gland Secretion Quality	Placebo	1.7	Standard Deviation 0.4	Units on a scale
Meibomian Gland Secretion Quality	5% IL-1Ra	1.8	Standard Deviation 0.6	Units on a scale
Tear Breakup Time (TBUT)	2.5% IL-1Ra	4.5	Standard Deviation 2.8	Seconds
Tear Breakup Time (TBUT)	Placebo	4.4	Standard Deviation 2.3	Seconds
Tear Breakup Time (TBUT)	5% IL-1Ra	3.9	Standard Deviation 2.0	Seconds
Corneal Fluorescein Staining Score	2.5% IL-1Ra	0.9	Standard Deviation 0.7	Units on a scale
Corneal Fluorescein Staining Score	Placebo	1.4	Standard Deviation 1.1	Units on a scale
Corneal Fluorescein Staining Score	5% IL-1Ra	1.4	Standard Deviation 0.8	Units on a scale
Ocular Surface Disease Index (OSDI)	Anakinra 2.5% Topical Ophthalmic Solution	31.8	Standard Deviation 24.1	units on a scale

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	2.5% IL-1Ra	30
Overall Study	STARTED	Placebo	30
Overall Study	STARTED	5% IL-1Ra	15
Overall Study	COMPLETED	2.5% IL-1Ra	28
Overall Study	COMPLETED	Placebo	24
Overall Study	COMPLETED	5% IL-1Ra	15
Overall Study	NOT COMPLETED	2.5% IL-1Ra	2
Overall Study	NOT COMPLETED	Placebo	6
Overall Study	NOT COMPLETED	5% IL-1Ra	0

Source ClinicalTrials.gov

Adverse events39

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Stinging Eye	Eye disorders	2.5% IL-1Ra	1	30	1
other	Stinging Eye	Eye disorders	Placebo	1	30	1
other	Stinging Eye	Eye disorders	5% IL-1Ra	0	15	0
other	Burning Eye	Eye disorders	2.5% IL-1Ra	1	30	1
other	Burning Eye	Eye disorders	Placebo	3	30	3
other	Burning Eye	Eye disorders	5% IL-1Ra	0	15	0
other	Grittiness	Eye disorders	2.5% IL-1Ra	3	30	3
other	Grittiness	Eye disorders	Placebo	0	30	0
other	Grittiness	Eye disorders	5% IL-1Ra	0	15	0
other	Itching Eye	Eye disorders	2.5% IL-1Ra	1	30	1

1 to 10 of 39Source ClinicalTrials.gov

See all 39 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	2.5% IL-1Ra	1	30
Total, all-cause mortality	Placebo	0	30
Total, all-cause mortality	5% IL-1Ra	0	15
Total, other adverse events	2.5% IL-1Ra	11	30
Total, other adverse events	Placebo	17	30
Total, other adverse events	5% IL-1Ra	2	15
Total, serious adverse events	2.5% IL-1Ra	1	30
Total, serious adverse events	Placebo	0	30
Total, serious adverse events	5% IL-1Ra	0	15

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
23599118	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00681109

GET https://conductscience.org/api/trials/v1/NCT00681109/events?page=2

API reference For AI assistants