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

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:

  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

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.

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

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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