NCT02040623

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 20, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
3 months until next milestone

Results Posted

Study results publicly available

October 10, 2016

Completed
Last Updated

October 10, 2016

Status Verified

August 1, 2016

Enrollment Period

2.3 years

First QC Date

January 16, 2014

Results QC Date

August 17, 2016

Last Update Submit

August 17, 2016

Conditions

Chronic Graft-versus-host Disease

Keywords

Chronic Graft versus Host DiseaseKeratoconjunctivitis Sicca

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline (Visit 1) of Total Corneal Fluorescein Staining Score at 12 Weeks.

    Change from baseline (Visit 1) of total CFS score at 12 weeks. Total CFS score range 0-20, where '0' represents no fluorescein staining of any region and '20' represents severe staining the entire cornea.

    Baseline to 12 weeks

Study Arms (3)

R348 Ophthalmic Solution, 0.2%

ACTIVE COMPARATOR

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

Drug: R348 Ophthalmic Solution, 0.2%

R348 Ophthalmic Solution, 0.5%

ACTIVE COMPARATOR

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

Drug: R348 Ophthalmic Solution, 0.5%

Placebo

PLACEBO COMPARATOR

Placebo Ophthalmic Solution 2 drops per eye twice a day

Other: Placebo Ophthalmic Solution

Interventions

R348 Ophthalmic Solution, 0.2%DRUG

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

Also known as: R932348
R348 Ophthalmic Solution, 0.2%
R348 Ophthalmic Solution, 0.5%DRUG

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

Also known as: R932348
R348 Ophthalmic Solution, 0.5%
Placebo Ophthalmic SolutionOTHER

Placebo Ophthalmic Solution 2 drops per eye twice a day

Placebo

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

U. Miami - Bascom Palmer Eye Institute

Plantation, Florida, 33324, United States

Location

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Bronchiolitis Obliterans SyndromeKeratoconjunctivitis Sicca

Condition Hierarchy (Ancestors)

Organizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System DiseasesKeratoconjunctivitisConjunctivitisConjunctival DiseasesEye DiseasesKeratitisCorneal DiseasesDry Eye SyndromesLacrimal Apparatus Diseases

Results Point of Contact

Title
Anne-Marie Duliege, MD
Organization
Rigel
clinicaltrials@rigel.com
650-624-1100

Study Officials

  • Rigel Pharmaceuticals, Inc.

    Rigel Pharmaceuticals,Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2014

First Posted

January 20, 2014

Study Start

March 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

October 10, 2016

Results First Posted

October 10, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

US(2)