Safety and Efficacy Study of EGP-437 (Dexamethasone Phosphate Formulated for Ocular Iontophoresis) to Treat Dry Eye
Evaluation of Dexamethasone Phosphate Delivered by Ocular Iontophoresis for the Treatment of Dry Eye in the Controlled Adverse Environment (CAE) Model
1 other identifier
interventional
198
1 country
5
Brief Summary
The purpose of this study is to assess the safety and efficacy of EGP-437 (dexamethasone phosphate formulated for ocular iontophoresis) using the EyeGate® II Iontophoresis system in patients with dry eye.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2010
Shorter than P25 for phase_3
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2010
CompletedFirst Posted
Study publicly available on registry
May 25, 2010
CompletedStudy Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedApril 27, 2011
April 1, 2011
7 months
May 20, 2010
April 25, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sign: Differences in corneal fluorescein staining (inferior region, Ora Scale) Visit 1 Pre-CAE to Visit 6 compared to placebo; Symptom: Ocular discomfort at Visit 5 as compared to placebo
Up to 10 weeks
Secondary Outcomes (1)
Sign: Corneal fluorescein staining (each region, Ora Scale); Symptom: Ocular discomfort pre- and post-CAE (Ora Scale)
Up to 10 weeks
Study Arms (3)
Ocular Iontophoresis EGP-437, Low Dose
ACTIVE COMPARATOROcular Iontophoresis with EGP-437 4.0 mA-min at 1.5 mA
Ocular Iontophoresis EGP-437, High Dose
ACTIVE COMPARATOROcular Iontophoresis with EGP-437 6.5 mA-min at 2.5 mA
Ocular Iontophoresis Placebo
PLACEBO COMPARATOROcular Iontophoresis with Placebo 6.5 mA-min at 2.5 mA
Interventions
Transscleral iontophoresis delivery of EGP-437 (dexamethasone phosphate formulated for ocular iontophoresis)
Eligibility Criteria
You may qualify if:
- Have a reported history of dry eye in each eye
- Be at least 12 years of age
- Demonstrate a response when exposed to the Controlled Adverse Environment model at Visits 1 and 2
You may not qualify if:
- Have contraindications to the use of the test articles
- Have known allergy or sensitivity to the study medications or their components
- Have any ocular infections, active ocular inflammation, or preauricular lymphadenopathy
- Be current contact lens wearers or wear contacts during the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
The Eye Care Group
Waterbury, Connecticut, 06708, United States
Central Maine Eye Care
Lewiston, Maine, 04240, United States
Andover Eye Associates
Andover, Massachusetts, 01810, United States
Total Eye Care
Memphis, Tennessee, 38119, United States
Virginia Eye Consultants
Norfolk, Virginia, 23502, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gail L Torkildsen, MD
Andover Eye Associates
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 20, 2010
First Posted
May 25, 2010
Study Start
June 1, 2010
Primary Completion
January 1, 2011
Study Completion
April 1, 2011
Last Updated
April 27, 2011
Record last verified: 2011-04