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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02040623
Other study ID # C-932348-004
Secondary ID
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


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
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