A Study of RX-10045 in the Treatment of Dry Eye Disease

Phase 2

Completed

• Conditions: Dry Eye Syndrome
• Interventions: Drug: Vehicle for RX-10045; Drug: RX-10045

• Registration Number: NCT01675570
• Lead Sponsor: C.T. Development America, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-28
• Study First Submitted QC: 2012-08-28
• Study First Posted: 2012-08-30
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-07
• Last Update Posted: 2013-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle for RX-10045 arm	Vehicle for RX-10045	Vehicle of RX-10045 Ophthalmic Solution
RX-10045 active arm	RX-10045	RX-10045 Opththalmic Solution, 0.09%

Primary Outcome Measures

Name	Time	Method
Worst symptom score	Baseline to day 28
Corneal staining	Baseline to day 28

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Andover Eye Associates; 🇺🇸 Andover, Massachusetts, United States