Safety and Efficacy Study of RX-10045 on the Signs and Symptoms of Dry Eye

September 20, 2010 updated by: Resolvyx Pharmaceuticals, Inc

A Phase II, Multi-Center, Double-Masked, Randomized, Placebo Controlled, Study on the Safety and Efficacy of RX-10045 on the Signs and Symptoms of Dry Eye in Every Day Environmental Conditions and During Provocation Using the Controlled Adverse Environment (CAE) Model

The purpose of this study is to compare the safety and efficacy of RX-10045 to placebo for the treatment of the signs and symptoms of dry eye.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

232

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

  • United States
    • Massachusetts
      • Andover, Massachusetts, United States, 01810
        • Ora Clinical

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:

  • Be at least 18 years of age;
  • Have provided written informed consent;
  • Have a history of dry eye for at least 6 months prior to enrollment;
  • Have a history of use or desire to use eye drops for dry eye symptoms within the past 6 months;
  • Demonstrate a response when exposed to the CAE.

Exclusion Criteria:

  • Have an on-going ocular infection, or active ocular inflammation
  • Have worn contact lenses within 72 hours of Visit 1 or have anticipated use of contact lenses during the study;
  • Have contact lens-induced dry eye;
  • Have previously had laser in situ keratomileusis (LASIK) surgery;
  • Be using or have anticipated use of temporary punctual plugs during the study;
  • Have best corrected visual acuity > +0.7 in both eyes;
  • Be a woman who is pregnant, nursing or planning a pregnancy;
  • Have a known allergy and/or sensitivity to the test article or its components;
  • Be currently using any medication known to cause ocular drying that is not used on a stable dosing regimen for at least 30 days

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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo eye drop
Experimental: RX-10045
Drug: RX-10045
RX-10045 eye drop

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Corneal fluorescein staining and integrated subject diary data
Time Frame: 28 days
28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in dry eye signs and symptoms
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Resolvyx Pharmaceuticals, Inc

Investigators

  • Principal Investigator: Gail Torkildsen, MD, Ophthalmic Research Associates, Andover, MA
  • Principal Investigator: John Lonsdale, MD, Central Maine Eye Care, Lewiston, ME
  • Principal Investigator: Joel Geffin, MD, The Eye Care Group, Waterbury, CT

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

November 1, 2008

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

November 26, 2008

First Submitted That Met QC Criteria

November 28, 2008

First Posted (Estimate)

December 1, 2008

Study Record Updates

Last Update Posted (Estimate)

September 24, 2010

Last Update Submitted That Met QC Criteria

September 20, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-004-03

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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