A Study of RX-10045 in the Treatment of Dry Eye Disease
A Phase II, Multi-Center, Randomized, Placebo-Controlled, Double-Masked Study of RX-10045 (0.09%) in the Treatment of Dry Eye Disease
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2012
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
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 28, 2012
CompletedFirst Posted
Study publicly available on registry
August 30, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedFebruary 8, 2013
February 1, 2013
3 months
August 28, 2012
February 7, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Corneal staining
Baseline to day 28
Worst symptom score
Baseline to day 28
Secondary Outcomes (3)
Ocular discomfort symptom score
Baseline to day 28
Tear film break-up time
Baseline to day 28
Visual-related function subscale of Ocular Surface Disease Index score
Baseline to day 28
Study Arms (2)
RX-10045 active arm
EXPERIMENTALRX-10045 Opththalmic Solution, 0.09%
Vehicle for RX-10045 arm
PLACEBO COMPARATORVehicle of RX-10045 Ophthalmic Solution
Interventions
One drop of RX-10045 ophthalmic solution will be instilled in each eye, twice a day, approximately 12 hours apart for 28 days.
One drop of RX-10045 placebo solution will be instilled in each eye, twice a day, approximately 12 hours apart for 28 days.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Andover Eye Associates
Andover, Massachusetts, 01810, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gail Torkildsen, MD
Andover Eye Associates
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2012
First Posted
August 30, 2012
Study Start
August 1, 2012
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
February 8, 2013
Record last verified: 2013-02