Back to resultsSafety and Efficacy Study of RX-10045 on the Signs and Symptoms of Dry Eye
Primary Purpose
Dry Eye Syndrome
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
RX-10045
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Syndrome focused on measuring Keratoconjunctivitis Sicca, Dry eye, Resolvin
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- ORA Clinical
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
RX-10045
Arm Description
Outcomes
Primary Outcome Measures
Corneal fluorescein staining and integrated subject diary data
Secondary Outcome Measures
Changes in dry eye signs and symptoms
Full Information
NCT ID
NCT00799552
First Posted
November 26, 2008
Last Updated
September 20, 2010
Sponsor
Resolvyx Pharmaceuticals, Inc
1. Study Identification
Unique Protocol Identification Number
NCT00799552
Brief Title
Safety and Efficacy Study of RX-10045 on the Signs and Symptoms of Dry Eye
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Resolvyx Pharmaceuticals, Inc
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndrome
Keywords
Keratoconjunctivitis Sicca, Dry eye, Resolvin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
232 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
RX-10045
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
RX-10045
Intervention Description
RX-10045 eye drop
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo eye drop
Primary Outcome Measure Information:
Title
Corneal fluorescein staining and integrated subject diary data
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Changes in dry eye signs and symptoms
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gail Torkildsen, MD
Organizational Affiliation
Ophthalmic Research Associates, Andover, MA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Lonsdale, MD
Organizational Affiliation
Central Maine Eye Care, Lewiston, ME
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joel Geffin, MD
Organizational Affiliation
The Eye Care Group, Waterbury, CT
Official's Role
Principal Investigator
Facility Information:
Facility Name
ORA Clinical
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.resolvyx.com
Description
Related Info
Learn more about this trial
Safety and Efficacy Study of RX-10045 on the Signs and Symptoms of Dry Eye
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