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CompletedNCT00799552Updated Sep 24, 2010

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

A Phase 2 interventional study of RX-10045 and Placebo in Dry Eye Syndrome, sponsored by Resolvyx Pharmaceuticals, Inc. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-09-24.

Sponsored by Resolvyx Pharmaceuticals, Inc · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
232
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Dry Eye Syndrome

Keywords

  • Keratoconjunctivitis Sicca
  • Dry eye
  • Resolvin
03

In context

Dry Eye Syndromes

1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.

This study's enrollment of 232 is above the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.

Browse Dry Eye Syndromes studies →

Lead sponsor

Resolvyx Pharmaceuticals, Inc is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
232 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Drug: Placebo

  • Experimental
    RX-10045

    Drug: RX-10045

Interventions

  • DrugRX-10045

    RX-10045 eye drop

  • DrugPlacebo

    Placebo eye drop

06

What researchers measure

Primary outcomes

  1. Corneal fluorescein staining and integrated subject diary data

    Time frame: 28 days

Secondary outcomes

  1. Changes in dry eye signs and symptoms

    Time frame: 28 days

07

Study locations

1 site
  • ORA Clinical
    Andover, Massachusetts 01810, United States
08

References and documents

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00799552
Lead sponsor
Resolvyx Pharmaceuticals, Inc
First posted
Dec 1, 2008
Start date
Nov 2008
Primary completion
May 2009
Completion
Jun 2009
Last update
Sep 24, 2010

Study contacts

Gail Torkildsen, MD
principal investigator · Ophthalmic Research Associates, Andover, MA
John Lonsdale, MD
principal investigator · Central Maine Eye Care, Lewiston, ME
Joel Geffin, MD
principal investigator · The Eye Care Group, Waterbury, CT

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.

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