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

This study has been completed.
Information provided by (Responsible Party):
C.T. Development America, Inc. Identifier:
First received: August 28, 2012
Last updated: February 7, 2013
Last verified: February 2013
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 Intervention Phase
Dry Eye Syndrome
Drug: RX-10045
Drug: Vehicle for RX-10045
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by C.T. Development America, Inc.:

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

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

Enrollment: 150
Study Start Date: August 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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

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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Please refer to this study by its identifier: NCT01675570

United States, Massachusetts
Andover Eye Associates
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
C.T. Development America, Inc.
Principal Investigator: Gail Torkildsen, MD Andover Eye Associates
  More Information

Responsible Party: C.T. Development America, Inc. Identifier: NCT01675570     History of Changes
Other Study ID Numbers: CTD1201
Study First Received: August 28, 2012
Last Updated: February 7, 2013

Keywords provided by C.T. Development America, Inc.:
Dry Eye Disease

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Conjunctival Diseases
Corneal Diseases
Lacrimal Apparatus Diseases
Pharmaceutical Solutions
Ophthalmic Solutions processed this record on April 28, 2017