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

• Sponsor: C.T. Development America, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01675570
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arms: 2
• Duration (Months): 3
• Patients Per Site Per Month: 49.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndrome	Drug: RX-10045; Drug: Vehicle for RX-10045	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Study Start Date: Aug 1, 2012
• Actual Primary Completion Date: Nov 1, 2012
• Actual Study Completion Date: Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: RX-10045 active arm RX-10045 Opththalmic Solution, 0.09%	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.
Placebo Comparator: Vehicle for RX-10045 arm Vehicle of RX-10045 Ophthalmic Solution	Drug: 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.

Outcome Measures

Primary Outcome Measures

1. Corneal staining [Baseline to day 28]

2. Worst symptom score [Baseline to day 28]

Secondary Outcome Measures

1. Ocular discomfort symptom score [Baseline to day 28]

2. Tear film break-up time [Baseline to day 28]

3. Visual-related function subscale of Ocular Surface Disease Index score [Baseline to day 28]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Andover Eye Associates	Andover	Massachusetts	United States	01810

Sponsors and Collaborators

• C.T. Development America, Inc.

Investigators

• Principal Investigator: Gail Torkildsen, MD, Andover Eye Associates

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: C.T. Development America, Inc.
• ClinicalTrials.gov Identifier: NCT01675570
• Other Study ID Numbers: CTD1201
• First Posted: Aug 30, 2012
• Last Update Posted: Feb 8, 2013
• Last Verified: Feb 1, 2013

• Keywords provided by C.T. Development America, Inc.: RX-10045; Dry Eye Disease
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases

Study Results

No Results Posted as of Feb 8, 2013