Safety and Efficacy Study of RX-10045 on the Signs and Symptoms of Dry Eye
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ClinicalTrials.gov Identifier: NCT00799552 |
Recruitment Status :
Completed
First Posted : December 1, 2008
Last Update Posted : September 24, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dry Eye Syndrome | Drug: RX-10045 Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 232 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | November 2008 |
Actual Primary Completion Date : | May 2009 |
Actual Study Completion Date : | June 2009 |
Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo |
Drug: Placebo
Placebo eye drop |
Experimental: RX-10045 |
Drug: RX-10045
RX-10045 eye drop |
- Corneal fluorescein staining and integrated subject diary data [ Time Frame: 28 days ]
- Changes in dry eye signs and symptoms [ Time Frame: 28 days ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00799552
United States, Massachusetts | |
ORA Clinical | |
Andover, Massachusetts, United States, 01810 |
Principal Investigator: | Gail Torkildsen, MD | Ophthalmic Research Associates, Andover, MA | |
Principal Investigator: | John Lonsdale, MD | Central Maine Eye Care, Lewiston, ME | |
Principal Investigator: | Joel Geffin, MD | The Eye Care Group, Waterbury, CT |
Responsible Party: | Per Gjorstrup, Chief Medical Officier, Resolvyx Pharmaceuticals, Inc |
ClinicalTrials.gov Identifier: | NCT00799552 |
Other Study ID Numbers: |
08-004-03 |
First Posted: | December 1, 2008 Key Record Dates |
Last Update Posted: | September 24, 2010 |
Last Verified: | September 2010 |
Keratoconjunctivitis Sicca Dry eye Resolvin |
Keratoconjunctivitis Sicca Dry Eye Syndromes Keratoconjunctivitis Conjunctivitis Conjunctival Diseases |
Eye Diseases Keratitis Corneal Diseases Lacrimal Apparatus Diseases |