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Completed

NCT Number: NCT01675570

A Study of RX-10045 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.

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Key information

Conditions

Dry Eye Syndrome Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Known contraindications or sensitivities to study medication or its components
  • Any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters
  • Use of disallowed medication during the period indicated prior to the enrollment or during the study
  • Be a female who is currently pregnant, planning a pregnancy, lactating, or not using a medically acceptable form of birth control

Treatment and study plan

RX-10045

Drug

One drop of RX-10045 ophthalmic solution will be instilled in each eye, twice a day, approximately 12 hours apart for 28 days.

Vehicle for RX-10045

Drug

One drop of RX-10045 placebo solution will be instilled in each eye, twice a day, approximately 12 hours apart for 28 days.

Primary outcomes

  1. Corneal staining

    Time frame: Baseline to day 28

  2. Worst symptom score

    Time frame: Baseline to day 28

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

C.T. Development America, Inc.

Industry

Registry information

Official study title

A Phase II, Multi-Center, Randomized, Placebo-Controlled, Double-Masked Study of RX-10045 (0.09%) in the Treatment of Dry Eye Disease

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Aug 30, 2012
Registry last updated
Feb 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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