Phase 3 Study of EBI-005 in Dry Eye Disease

Sponsor

Eleven Biotherapeutics (Industry)

Overall Status

Completed

CT.gov ID

NCT01998802

Collaborator

(none)

670

Enrollment

Locations

Arms

14.9

Duration (Months)

14.9

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a phase III double-masked, randomized, controlled study evaluating the efficacy of EBI-005 as compared to vehicle given as a topical ophthalmic solution in each eye to subjects with moderate to severe DED three times daily for 12 weeks. Approximately 730 subjects at up to approximately 50 centers in the United States will be screened, enrolled into the study.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Disease (DED)	Drug: Active Comparator EBI-005 Drug: Placebo Comparator	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

670 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

A Multi-Center, Double-Masked, Randomized, Controlled, Efficacy and Safety Study of EBI-005 5 mg/mL Topical Ophthalmic Solution Versus Vehicle Contraol In Subjects With Moderate to Severe Dry Eye Disease

Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Mar 1, 2015

Actual Study Completion Date :

Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Active Comparator: EBI-005 Drug: EBI-005 The investigational drug EBI-005, is an intervention to one of two study arms: 5 mg/mL topical administered 3 times per day.	Drug: Active Comparator EBI-005
Placebo Comparator: Placebo Comparator One of two study arms: placebo topical administered 3 times per day.	Drug: Placebo Comparator

Arm

Intervention/Treatment

Active Comparator: Active Comparator: EBI-005

Drug: EBI-005 The investigational drug EBI-005, is an intervention to one of two study arms: 5 mg/mL topical administered 3 times per day.

Drug: Active Comparator EBI-005

Placebo Comparator: Placebo Comparator

One of two study arms: placebo topical administered 3 times per day.

Drug: Placebo Comparator

Outcome Measures

Primary Outcome Measures

NEI score for Total Corneal Fluorescein Staining (TCFS) [3 months]
To evaluate the efficacy of EBI-005 5 mg/mL topical ophthalmic solution given three times daily for 12 weeks as measured by the change in the NEI score for the Total Corneal Fluorescein Staining [sign] from baseline to Week 12 and a change in ocular pain as measured by the painful or sore eye question on the OSDI [symptom] of DED from baseline to Week 12 as compared to vehicle control.

Secondary Outcome Measures

The key secondary endpoint is total OSDI score [3 months]
Change from baseline to week 12 in Total OSDI score.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Give written informed consent and any authorizations required by local law (e.g., Protected Health Information waiver) prior to performing any study procedures;
Are ≥ 18 years of age;
Are willing and able to follow instructions and can be present for the required study visits for the duration of the study;
Have a history of dry eye disease (DED) in both eyes supported by a previous clinical diagnosis
Have normal lid anatomy.
If female and of child bearing potential, she must not be not pregnant or lactating and not sexually active (abstinent) within 14 days prior to Visit 1

Exclusion Criteria:

Have signs of infection (i.e., fever or current treatment with antibiotics)
Have been exposed to an investigational drug/device within the preceding 30 days
Be an employee of the site that is directly involved in the management, administration, or support of the study, or be an immediate family member of the same
Be unwilling to or unable to comply with the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigational Site	Chandler	Arizona	United States	85225
2	Investigational Site	Mesa	Arizona	United States	85208
3	Investigational Site	Little Rock	Arkansas	United States	72212
4	Investigational Site	Artesia	California	United States	90701
5	Investigational Site	Mission Hills	California	United States	91345
6	Investigational Site	Petaluma	California	United States	94954
7	Investigational Site	Rancho Cordova	California	United States	95670
8	Investiational Site	San Diego	California	United States	92115
9	Investigational Site	Torrence	California	United States	90505
10	Investigational Site	Littleton	Colorado	United States	80120
11	Investigational Site	Hamden	Connecticut	United States	06518
12	Investigational Site	Plantation	Florida	United States	33324
13	Investigational Site	Roswell	Georgia	United States	30076
14	Investigational Site	Bloomingdale	Illinois	United States	60108
15	Investigational Site	Indianapolis	Indiana	United States	46260
16	Investigational Site	Indianapolis	Indiana	United States	46290
17	Investigational Site	New Albany	Indiana	United States	47150
18	Investigational Site	Lexington	Kentucky	United States	40509
19	Investigational Site	Louisville	Kentucky	United States	40206
20	Investigational Site	Louisville	Kentucky	United States	40217
21	Investigational Site	Bangor	Maine	United States	04401
22	Investigational Site	Boston	Massachusetts	United States	02114
23	Investigational Site	Winchester	Massachusetts	United States	01890
24	Investigational Site	Chesterfield	Missouri	United States	63017
25	Investigational Site	Des Peres	Missouri	United States	63131
26	Investigational Site	Kansas City	Missouri	United States	64111
27	Investigational Site	St. Louis	Missouri	United States	63131
28	Investigational Site	Washington	Missouri	United States	63090
29	Investigational Site	Las Vegas	Nevada	United States	89148
30	Investigational Site	New York	New York	United States	10036
31	Investigational Site	Rochester	New York	United States	14618
32	Investigational Site	Wantagh	New York	United States	11793
33	Investigational Site	High Point	North Carolina	United States	27262
34	Investigational Site	Cleveland	Ohio	United States	44115
35	Investigational Site	Cranberry Township	Pennsylvania	United States	16066
36	Investigational Site	Lancaster	Pennsylvania	United States	17601
37	Investigational Site	Pittsburgh	Pennsylvania	United States	15213
38	Investigational Site	Rapid City	South Dakota	United States	57701
39	Investigational Site	Memphis	Tennessee	United States	38119
40	Investigational Site	Houston	Texas	United States	77034
41	Investigational Site#2	Houston	Texas	United States	77055
42	Investigational Site	League City	Texas	United States	77573
43	Investigational Site	San Antonio	Texas	United States	78209
44	Investigational Site# 2	San Antonio	Texas	United States	78229
45	Investigational Site	Norfolk	Virginia	United States	23502

Sponsors and Collaborators

Eleven Biotherapeutics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eleven Biotherapeutics

ClinicalTrials.gov Identifier:

NCT01998802

Other Study ID Numbers:

EBI-005-3

First Posted:

Dec 2, 2013

Last Update Posted:

Jun 11, 2015

Last Verified:

Jun 1, 2015

Additional relevant MeSH terms:

Dry Eye Syndromes

Keratoconjunctivitis Sicca

Eye Diseases

Study Results

No Results Posted as of Jun 11, 2015