NCT01675570CompletedPhase 2

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 enrollmentStarted: August 2012Last updated: February 8, 2013

Conditions

Interventions

Drugs

Trial Snapshot

Phase: Phase 2
Status: Completed
Sponsor: C.T. Development America, Inc.
Enrollment: 150
Locations: 1
Primary Endpoint: Corneal staining

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study 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.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Primary Purpose: Treatment
Masking: Double (Participant, Investigator)

Eligibility Criteria

Ages: 18 Years to — (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

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

Experimental

RX-10045 Opththalmic Solution, 0.09%

Intervention: RX-10045 (Drug)

Vehicle for RX-10045 arm

Placebo Comparator

Vehicle of RX-10045 Ophthalmic Solution

Intervention: Vehicle for RX-10045 (Drug)

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)

Investigators

Sponsor

C.T. Development America, Inc.

Sponsor Class

Industry

Responsible Party

Sponsor

Study Sites (1)

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