Phase 2
N=35
Safety and Efficacy Study of R932348 Ophthalmic Solution in Chronic Ocular Graft Versus Host Disease Patients(DROPS-2)
Chronic Graft-versus-host Disease
Bottom Line
View on ClinicalTrials.gov: NCT02040623 ↗Enrolled (actual)
35
Serious AEs
11.4%
Results posted
Oct 2016
Primary outcome: Primary: Change From Baseline (Visit 1) of Total Corneal Fluorescein Staining Score at 12 Weeks. — -4.2; -6.2; -2.1 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- R348 Ophthalmic Solution, 0.2% (Drug); R348 Ophthalmic Solution, 0.5% (Drug); Placebo Ophthalmic Solution (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rigel Pharmaceuticals
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline (Visit 1) of Total Corneal Fluorescein Staining Score at 12 Weeks. |
-4.2; -6.2; -2.1 | — |
Summary
* To assess the efficacy of R348 Ophthalmic Solutions administered for 12 weeks to subjects evaluated by objective and subjective measures.
* To investigate the safety and tolerability of R348 Ophthalmic Solutions administered for 12 weeks to subjects.
Eligibility Criteria
Inclusion Criteria
- Received an Allogeneic hematologic stem cell transplantation at least 3 months prior.
- Subjects with post Allogeneic hematologic stem cell transplantation onset or worsening of dry eye symptoms for at least 1 month prior.
- Use of over-the-counter and/or prescription eye drops for dry eye symptoms within 1 month.
- Corneal fluorescein staining score of ≥ 2 in 1 region and ≥ 1 in at least 1 other region.
- Total lissamine green conjunctival staining score (according to a modified National Eye Institute grading system) of ≥ 2.
Exclusion Criteria
- Clinically unstable Graft versus Host Disease (requiring a change in immunosuppressive regimen), medical condition, or laboratory abnormality
- Used topical ophthalmic cyclosporine within 45 days.
- Used any topical ophthalmic steroid within 2 weeks.
- Used autologous serum eye drops within 2 weeks.
Data sourced from ClinicalTrials.gov (NCT02040623). 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.