Safety and Efficacy Study of R932348 Ophthalmic Solution in Chronic Ocular Graft Versus Host Disease Patients(DROPS-2)

Rigel Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Chronic Graft-versus-host Disease

Treatments: Other: Placebo Ophthalmic Solution; Drug: R348 Ophthalmic Solution, 0.5%; Drug: R348 Ophthalmic Solution, 0.2%

Study type: Interventional

Funder types: Industry

Identifiers

NCT02040623

C-932348-004

Details and patient eligibility

About

• 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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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35 participants in 3 patient groups, including a placebo group

R348 Ophthalmic Solution, 0.2%

Active Comparator group

Description:

R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day

Treatment:

Drug: R348 Ophthalmic Solution, 0.2%

R348 Ophthalmic Solution, 0.5%

Active Comparator group

Description:

R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day

Treatment:

Drug: R348 Ophthalmic Solution, 0.5%

Placebo

Placebo Comparator group

Description:

Placebo Ophthalmic Solution 2 drops per eye twice a day

Treatment:

Other: Placebo Ophthalmic Solution