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

C.T. Development America, Inc.1 site in 1 country150 target enrollmentAugust 2012

ConditionsDry Eye Syndrome

InterventionsRX-10045 Vehicle for RX-10045

DrugsRX-10045 Vehicle for RX-10045

Overview

Phase: Phase 2
Intervention: RX-10045
Conditions: Dry Eye Syndrome
Sponsor: C.T. Development America, Inc.
Enrollment: 150
Locations: 1
Primary Endpoint: Corneal staining
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

August 2012

End Date

November 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

C.T. Development America, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

RX-10045 active arm

RX-10045 Opththalmic Solution, 0.09%

Intervention: RX-10045

Vehicle for RX-10045 arm

Vehicle of RX-10045 Ophthalmic Solution

Intervention: Vehicle for RX-10045

Outcomes

Primary Outcomes

Corneal staining

Time Frame: Baseline to day 28

Worst symptom score

Time Frame: Baseline to day 28

Secondary Outcomes

Ocular discomfort symptom score(Baseline to day 28)
Tear film break-up time(Baseline to day 28)
Visual-related function subscale of Ocular Surface Disease Index score(Baseline to day 28)