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Completed

NCT Number: NCT01998802

Phase 3 Study of EBI-005 in Dry Eye Disease

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.

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Key information

Conditions

Dry Eye Disease (DED) Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigational Site, Chandler, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active Comparator EBI-005

Drug

placebo comparator

Drug

Primary outcomes

  1. NEI score for Total Corneal Fluorescein Staining (TCFS)

    Time frame: 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 outcomes

  1. The key secondary endpoint is total OSDI score

    Time frame: 3 months

    Change from baseline to week 12 in Total OSDI score.

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Sponsors and collaborators

Lead sponsor

Eleven Biotherapeutics

Industry

Registry information

Official study 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

Acronym: EBI-005

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 2, 2013
Registry last updated
Jun 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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