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

Chronic Graft-versus-host Disease Clinical Trial

— DROPS-2  

Official title:

A Phase 2, Multi-Center, Randomized, Double-Masked, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of 0.2% and 0.5% R932348 Ophthalmic Solutions for the Treatment of Keratoconjunctivitis Sicca in Patients With Chronic Ocular Graft Versus Host Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02040623
• Other study ID #: C-932348-004
• Status: Completed
• Phase: Phase 2
• First received: January 16, 2014
• Last updated: July 12, 2016
• Start date: March 2014
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: Rigel Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Graft-versus-host Disease
• Dry Eye Syndromes
• Graft vs Host Disease
• Keratoconjunctivitis
• Keratoconjunctivitis Sicca

Intervention

Drug:
• R348 Ophthalmic Solution, 0.2%
R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day
• R348 Ophthalmic Solution, 0.5%
R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day

Other:
• Placebo Ophthalmic Solution
Placebo Ophthalmic Solution 2 drops per eye twice a day

Locations

Country	Name	City	State
United States	Massachusetts Eye and Ear Infirmary	Boston	Massachusetts
United States	U. Miami - Bascom Palmer Eye Institute	Plantation	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Rigel Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change of total Corneal fluorescein staining score		Baseline to 12 weeks	No