Safety and Efficacy Study of RX-10045 on the Signs and Symptoms of Dry Eye

Dry Eye Syndrome Clinical Trial

Official title:

A Phase II, Multi-Center, Double-Masked, Randomized, Placebo Controlled, Study on the Safety and Efficacy of RX-10045 on the Signs and Symptoms of Dry Eye in Every Day Environmental Conditions and During Provocation Using the Controlled Adverse Environment (CAE) Model

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00799552
• Other study ID #: 08-004-03
• Status: Completed
• Phase: Phase 2
• First received: November 26, 2008
• Last updated: September 20, 2010
• Start date: November 2008
• Est. completion date: June 2009

Study information

• Verified date: September 2010
• Source: Resolvyx Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the safety and efficacy of RX-10045 to placebo for the treatment of the signs and symptoms of dry eye.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 232
• Est. completion date: June 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Be at least 18 years of age;

• Have provided written informed consent;

• Have a history of dry eye for at least 6 months prior to enrollment;

• Have a history of use or desire to use eye drops for dry eye symptoms within the past 6 months;

• Demonstrate a response when exposed to the CAE.

Exclusion Criteria:

• Have an on-going ocular infection, or active ocular inflammation

• Have worn contact lenses within 72 hours of Visit 1 or have anticipated use of contact lenses during the study;

• Have contact lens-induced dry eye;

• Have previously had laser in situ keratomileusis (LASIK) surgery;

• Be using or have anticipated use of temporary punctual plugs during the study;

• Have best corrected visual acuity > +0.7 in both eyes;

• Be a woman who is pregnant, nursing or planning a pregnancy;

• Have a known allergy and/or sensitivity to the test article or its components;

• Be currently using any medication known to cause ocular drying that is not used on a stable dosing regimen for at least 30 days

Study Design

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

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Signs and Symptoms

Intervention

Drug:
• RX-10045
RX-10045 eye drop
• Placebo
Placebo eye drop

Locations

Country	Name	City	State
United States	ORA Clinical	Andover	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Resolvyx Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal fluorescein staining and integrated subject diary data		28 days	No
Secondary	Changes in dry eye signs and symptoms		28 days	Yes