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A Study of RX-10045 in the Treatment of Dry Eye Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01675570
Recruitment Status : Completed
First Posted : August 30, 2012
Last Update Posted : February 8, 2013
Sponsor:
Information provided by (Responsible Party):
C.T. Development America, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dry Eye Syndrome Drug: RX-10045 Drug: Vehicle for RX-10045 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : August 2012
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arms and Interventions
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Arm Intervention/treatment
Experimental: RX-10045 active arm
RX-10045 Opththalmic Solution, 0.09%
 Drug: RX-10045
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
 Drug: Vehicle for RX-10045
One drop of RX-10045 placebo solution will be instilled in each eye, twice a day, approximately 12 hours apart for 28 days.


Outcome Measures
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Primary Outcome Measures :
  1. Corneal staining [ Time Frame: Baseline to day 28 ]
  2. Worst symptom score [ Time Frame: Baseline to day 28 ]

Secondary Outcome Measures :
  1. Ocular discomfort symptom score [ Time Frame: Baseline to day 28 ]
  2. Tear film break-up time [ Time Frame: Baseline to day 28 ]
  3. Visual-related function subscale of Ocular Surface Disease Index score [ Time Frame: Baseline to day 28 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Have a patient reported history of dry eye in both eyes
  2. Presence of dry eye symptoms
  3. Presence of dry eye signs, destabilized tear film break-up time and corneal staining

Exclusion Criteria:

  1. Known contraindications or sensitivities to study medication or its components
  2. Any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters
  3. Use of disallowed medication during the period indicated prior to the enrollment or during the study
  4. Be a female who is currently pregnant, planning a pregnancy, lactating, or not using a medically acceptable form of birth control
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01675570


Locations
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United States, Massachusetts
Andover Eye Associates
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
C.T. Development America, Inc.
Investigators
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Principal Investigator: Gail Torkildsen, MD Andover Eye Associates
More Information
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Responsible Party: C.T. Development America, Inc.
ClinicalTrials.gov Identifier: NCT01675570    
Other Study ID Numbers: CTD1201
First Posted: August 30, 2012    Key Record Dates
Last Update Posted: February 8, 2013
Last Verified: February 2013
Keywords provided by C.T. Development America, Inc.:
RX-10045
Dry Eye Disease
Additional relevant MeSH terms:
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Dry Eye Syndromes
Keratoconjunctivitis Sicca
Eye Diseases
Lacrimal Apparatus Diseases
Keratoconjunctivitis
 Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases