Back to resultsA Study of RX-10045 in the Treatment of Dry Eye Disease
Primary Purpose
Dry Eye Syndrome
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
RX-10045
Vehicle for RX-10045
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Syndrome focused on measuring RX-10045, Dry Eye Disease
Eligibility Criteria
Inclusion Criteria:
- Have a patient reported history of dry eye in both eyes
- Presence of dry eye symptoms
- Presence of dry eye signs, destabilized tear film break-up time and corneal staining
Exclusion Criteria:
- Known contraindications or sensitivities to study medication or its components
- Any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters
- Use of disallowed medication during the period indicated prior to the enrollment or during the study
- Be a female who is currently pregnant, planning a pregnancy, lactating, or not using a medically acceptable form of birth control
Sites / Locations
- Andover Eye Associates
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
RX-10045 active arm
Vehicle for RX-10045 arm
Arm Description
RX-10045 Opththalmic Solution, 0.09%
Vehicle of RX-10045 Ophthalmic Solution
Outcomes
Primary Outcome Measures
Corneal staining
Worst symptom score
Secondary Outcome Measures
Ocular discomfort symptom score
Tear film break-up time
Visual-related function subscale of Ocular Surface Disease Index score
Full Information
NCT ID
NCT01675570
First Posted
August 28, 2012
Last Updated
February 7, 2013
Sponsor
C.T. Development America, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01675570
Brief Title
A Study of RX-10045 in the Treatment of Dry Eye Disease
Official Title
A Phase II, Multi-Center, Randomized, Placebo-Controlled, Double-Masked Study of RX-10045 (0.09%) in the Treatment of Dry Eye Disease
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
C.T. Development America, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary purpose of this study is to assess the efficacy, tolerability and safety of RX-10045 Ophthalmic Solution in patients with Dry Eye Disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndrome
Keywords
RX-10045, Dry Eye Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RX-10045 active arm
Arm Type
Experimental
Arm Description
RX-10045 Opththalmic Solution, 0.09%
Arm Title
Vehicle for RX-10045 arm
Arm Type
Placebo Comparator
Arm Description
Vehicle of RX-10045 Ophthalmic Solution
Intervention Type
Drug
Intervention Name(s)
RX-10045
Intervention Description
One drop of RX-10045 ophthalmic solution will be instilled in each eye, twice a day, approximately 12 hours apart for 28 days.
Intervention Type
Drug
Intervention Name(s)
Vehicle for RX-10045
Intervention Description
One drop of RX-10045 placebo solution will be instilled in each eye, twice a day, approximately 12 hours apart for 28 days.
Primary Outcome Measure Information:
Title
Corneal staining
Time Frame
Baseline to day 28
Title
Worst symptom score
Time Frame
Baseline to day 28
Secondary Outcome Measure Information:
Title
Ocular discomfort symptom score
Time Frame
Baseline to day 28
Title
Tear film break-up time
Time Frame
Baseline to day 28
Title
Visual-related function subscale of Ocular Surface Disease Index score
Time Frame
Baseline to day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have a patient reported history of dry eye in both eyes
Presence of dry eye symptoms
Presence of dry eye signs, destabilized tear film break-up time and corneal staining
Exclusion Criteria:
Known contraindications or sensitivities to study medication or its components
Any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters
Use of disallowed medication during the period indicated prior to the enrollment or during the study
Be a female who is currently pregnant, planning a pregnancy, lactating, or not using a medically acceptable form of birth control
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gail Torkildsen, MD
Organizational Affiliation
Andover Eye Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Andover Eye Associates
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of RX-10045 in the Treatment of Dry Eye Disease
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