Phase 3 Study of EBI-005 in Dry Eye Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Eleven Biotherapeutics
Sponsor:
Information provided by (Responsible Party):
Eleven Biotherapeutics
ClinicalTrials.gov Identifier:
NCT01998802
First received: November 25, 2013
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Eleven Biotherapeutics:

Primary Outcome Measures:
  • NEI score for Total Corneal Fluorescein Staining (TCFS) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Change from baseline to week 12 in Total OSDI score.


Estimated Enrollment: 730
Study Start Date: January 2014
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01998802

Contacts
Contact: Jennifer Agahigian 5084797919 Jennifer.Agahigian@elevenbio.com

  Show 31 Study Locations
Sponsors and Collaborators
Eleven Biotherapeutics
  More Information

No publications provided

Responsible Party: Eleven Biotherapeutics
ClinicalTrials.gov Identifier: NCT01998802     History of Changes
Other Study ID Numbers: EBI-005-3
Study First Received: November 25, 2013
Last Updated: July 10, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Eye Diseases
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014