Safety and Efficacy Study of RX-10045 on the Signs and Symptoms of Dry Eye
A Phase II, Multi-Center, Double-Masked, Randomized, Placebo Controlled, Study on the Safety and Efficacy of RX-10045 on the Signs and Symptoms of Dry Eye in Every Day Environmental Conditions and During Provocation Using the Controlled Adverse Environment (CAE) Model
1 other identifier
interventional
232
1 country
1
Brief Summary
The purpose of this study is to compare the safety and efficacy of RX-10045 to placebo for the treatment of the signs and symptoms of dry eye.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2008
Shorter than P25 for phase_2
1 active site
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
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 26, 2008
CompletedFirst Posted
Study publicly available on registry
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedSeptember 24, 2010
September 1, 2010
6 months
November 26, 2008
September 20, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Corneal fluorescein staining and integrated subject diary data
28 days
Secondary Outcomes (1)
Changes in dry eye signs and symptoms
28 days
Study Arms (2)
Placebo
PLACEBO COMPARATORRX-10045
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Be at least 18 years of age;
- Have provided written informed consent;
- Have a history of dry eye for at least 6 months prior to enrollment;
- Have a history of use or desire to use eye drops for dry eye symptoms within the past 6 months;
- Demonstrate a response when exposed to the CAE.
You may not qualify if:
- Have an on-going ocular infection, or active ocular inflammation
- Have worn contact lenses within 72 hours of Visit 1 or have anticipated use of contact lenses during the study;
- Have contact lens-induced dry eye;
- Have previously had laser in situ keratomileusis (LASIK) surgery;
- Be using or have anticipated use of temporary punctual plugs during the study;
- Have best corrected visual acuity \> +0.7 in both eyes;
- Be a woman who is pregnant, nursing or planning a pregnancy;
- Have a known allergy and/or sensitivity to the test article or its components;
- Be currently using any medication known to cause ocular drying that is not used on a stable dosing regimen for at least 30 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ORA Clinical
Andover, Massachusetts, 01810, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gail Torkildsen, MD
Ophthalmic Research Associates, Andover, MA
- PRINCIPAL INVESTIGATOR
John Lonsdale, MD
Central Maine Eye Care, Lewiston, ME
- PRINCIPAL INVESTIGATOR
Joel Geffin, MD
The Eye Care Group, Waterbury, CT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- 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
November 26, 2008
First Posted
December 1, 2008
Study Start
November 1, 2008
Primary Completion
May 1, 2009
Study Completion
June 1, 2009
Last Updated
September 24, 2010
Record last verified: 2010-09