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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 670
- Locations
- 4
- Primary Endpoint
- NEI score for Total Corneal Fluorescein Staining (TCFS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Active Comparator EBI-005 (Drug)
Placebo Comparator
One of two study arms: placebo topical administered 3 times per day.
Intervention: Placebo Comparator (Drug)
Outcomes
Primary Outcomes
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
- The key secondary endpoint is total OSDI score(3 months)