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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00799552

Enrollment

232

Registered

2008-12-01

Start date

2008-11-30

Completion date

2009-06-30

Last updated

2010-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Syndrome

Keywords

Keratoconjunctivitis Sicca, Dry eye, Resolvin

Brief 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.

Interventions

DRUGRX-10045

RX-10045 eye drop

DRUGPlacebo

Placebo eye drop

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Corneal fluorescein staining and integrated subject diary data	28 days

Secondary

Measure	Time frame
Changes in dry eye signs and symptoms	28 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026