Phase 3 Study of EBI-005 in Dry Eye Disease

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01998802

Acronym

EBI-005

Enrollment

670

Registered

2013-12-02

Start date

2014-01-31

Completion date

2015-04-30

Last updated

2015-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Disease (DED)

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.

Interventions

DRUGActive Comparator EBI-005

DRUGPlacebo Comparator

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
The key secondary endpoint is total OSDI score	3 months	Change from baseline to week 12 in Total OSDI score.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026