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Phase 3 Study of EBI-005 in D...

Phase 3 Study of EBI-005 in Dry Eye Disease

NCT ID: NCT01998802

Last Updated: 2015-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

670 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-04-30

Brief Summary

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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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Detailed Description

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Conditions

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Dry Eye Disease (DED)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Active Comparator EBI-005

Intervention Type DRUG

Placebo Comparator

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

Group Type PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type DRUG

Interventions

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Active Comparator EBI-005

Intervention Type DRUG

Placebo Comparator

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers