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

Dry Eye Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01675570
• Other study ID #: CTD1201
• Status: Completed
• Phase: Phase 2
• First received: August 28, 2012
• Last updated: February 7, 2013
• Start date: August 2012
• Est. completion date: November 2012

Study information

• Verified date: February 2013
• Source: C.T. Development America, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

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

Locations

Country	Name	City	State
United States	Andover Eye Associates	Andover	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
C.T. Development America, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal staining		Baseline to day 28	No
Primary	Worst symptom score		Baseline to day 28	No
Secondary	Ocular discomfort symptom score		Baseline to day 28	No
Secondary	Tear film break-up time		Baseline to day 28	No
Secondary	Visual-related function subscale of Ocular Surface Disease Index score		Baseline to day 28	No