Phase 2
N=204
To Assess the Safety and Efficacy of R932348 Ophthalmic Solutions in Patients With Keratoconjunctivitis Sicca
Keratoconjunctivitis Sicca
Bottom Line
View on ClinicalTrials.gov: NCT01900249 ↗Enrolled (actual)
204
Serious AEs
2.9%
Results posted
Oct 2016
Primary outcome: Primary: Change of Corneal Fluorescein Staining of the Inferior Cornea Region. — -1.00; -0.78; -0.78 units on a scale (Likert)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- R348 Ophthalmic Solution, 0.2% (Drug); R348 Ophthalmic Solution, 0.5% (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rigel Pharmaceuticals
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Corneal Fluorescein Staining of the Inferior Cornea Region. |
-1.00; -0.78; -0.78 | — |
Summary
The purpose of this study is to determine whether 0.2% and 0.5% R348 Ophthalmic Solutions are safe and effective in the treatment of Patients with Keratoconjunctivitis Sicca.
Eligibility Criteria
Inclusion Criteria
- A history of dry eye (based on the date of initial dry eye symptoms)
- Use of over-the-counter (OTC) and/or prescription eye drops for dry eye symptoms
- Corneal fluorescein staining score of at least 2 in the inferior region
Exclusion Criteria
- History of, or a concurrent clinically significant illness, medical condition (other than Keratoconjunctivitis Sicca or Sjögren's syndrome), or laboratory abnormality that, in the Investigator's opinion, could affect the conduct of the study.
- Use of ophthalmic cyclosporine within 45 days of Visit 1.
- Use of any topical ophthalmic steroid within 2 weeks of Visit 1.
- Have worn contact lenses or anticipate using contact lenses during the study.
- Have a condition or be in a situation that the Investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.
- Have a history of alcohol or substance abuse that, in the judgment of the Investigator, may impair or risk the subject's full participation in the study.
Data sourced from ClinicalTrials.gov (NCT01900249). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.