- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01675570
A Study of RX-10045 in the Treatment of Dry Eye Disease
February 7, 2013 updated by: C.T. Development America, Inc.
A Phase II, Multi-Center, Randomized, Placebo-Controlled, Double-Masked Study of RX-10045 (0.09%) in the Treatment of Dry Eye Disease
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
150
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Andover, Massachusetts, United States, 01810
- Andover Eye Associates
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: RX-10045 active arm
RX-10045 Opththalmic Solution, 0.09%
|
One drop of RX-10045 ophthalmic solution will be instilled in each eye, twice a day, approximately 12 hours apart for 28 days.
|
PLACEBO_COMPARATOR: Vehicle for RX-10045 arm
Vehicle of RX-10045 Ophthalmic Solution
|
One drop of RX-10045 placebo solution will be instilled in each eye, twice a day, approximately 12 hours apart for 28 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Corneal staining
Time Frame: Baseline to day 28
|
Baseline to day 28
|
Worst symptom score
Time Frame: Baseline to day 28
|
Baseline to day 28
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Ocular discomfort symptom score
Time Frame: Baseline to day 28
|
Baseline to day 28
|
Tear film break-up time
Time Frame: Baseline to day 28
|
Baseline to day 28
|
Visual-related function subscale of Ocular Surface Disease Index score
Time Frame: Baseline to day 28
|
Baseline to day 28
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (ACTUAL)
November 1, 2012
Study Completion (ACTUAL)
November 1, 2012
Study Registration Dates
First Submitted
August 28, 2012
First Submitted That Met QC Criteria
August 28, 2012
First Posted (ESTIMATE)
August 30, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
February 8, 2013
Last Update Submitted That Met QC Criteria
February 7, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTD1201
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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