Safety and Efficacy Study of R932348 Ophthalmic Solution in Chronic Ocular Graft Versus Host Dise… (NCT02040623) | Clinical Trial Compass
CompletedPhase 2
Safety and Efficacy Study of R932348 Ophthalmic Solution in Chronic Ocular Graft Versus Host Disease Patients(DROPS-2)
United States35 participantsStarted 2014-03
Plain-language 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.
Who can participate
Age range18 Years – 85 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Change From Baseline (Visit 1) of Total Corneal Fluorescein Staining Score at 12 Weeks.