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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
C.T. Development America, Inc.
ClinicalTrials.gov Identifier:
NCT01675570
First received: August 28, 2012
Last updated: February 7, 2013
Last verified: February 2013
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
  • Worst symptom score [ Time Frame: Baseline to day 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ocular discomfort symptom score [ Time Frame: Baseline to day 28 ] [ Designated as safety issue: No ]
  • Tear film break-up time [ Time Frame: Baseline to day 28 ] [ Designated as safety issue: No ]
  • Visual-related function subscale of Ocular Surface Disease Index score [ Time Frame: Baseline to day 28 ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01675570

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

No publications provided

Responsible Party: C.T. Development America, Inc.
ClinicalTrials.gov Identifier: NCT01675570     History of Changes
Other Study ID Numbers: CTD1201
Study First Received: August 28, 2012
Last Updated: February 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by C.T. Development America, Inc.:
RX-10045
Dry Eye Disease

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014