Chronic Graft-versus-host DiseasePhase 2DROPS-2NCT02040623
Safety and Efficacy Study of R932348 Ophthalmic Solution in Chronic Ocular Graft Versus Host Disease Patients(DROPS-2)
A Phase 2 study testing R348 Ophthalmic Solution, 0.2% and R348 Ophthalmic Solution, 0.5% in people with Chronic Graft-versus-host Disease, run by Rigel Pharmaceuticals at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Graft-versus-host Disease
- What is being tested?
- R348 Ophthalmic Solution, 0.2% and R348 Ophthalmic Solution, 0.5%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2014to Jul 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114
U. Miami - Bascom Palmer Eye Institute
Plantation, Florida, 33324
About this study
Official title: 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
- 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.
- Conditions
- Chronic Graft-versus-host Disease
- Being tested
- R348 Ophthalmic Solution, 0.2%, R348 Ophthalmic Solution, 0.5%, Placebo Ophthalmic Solution
- Keywords
- Chronic Graft versus Host Disease, Keratoconjunctivitis Sicca
- Medical subject headings
- Bronchiolitis Obliterans Syndrome, Keratoconjunctivitis Sicca
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R348 Ophthalmic Solution, 0.2%Drug
Also called R932348
R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day
R348 Ophthalmic Solution, 0.5%Drug
Also called R932348
R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day
Placebo Ophthalmic SolutionOther
Placebo Ophthalmic Solution 2 drops per eye twice a day
| Study group | Role | What they receive |
|---|---|---|
| R348 Ophthalmic Solution, 0.2% | Active comparator | R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day Receives: 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 Receives: Drug: R348 Ophthalmic Solution, 0.5% |
| Placebo | Placebo comparator | Placebo Ophthalmic Solution 2 drops per eye twice a day Receives: Other: Placebo Ophthalmic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startMar 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Graft-versus-host DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rigel Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rigel Pharmaceuticals, Inc., Study director, Rigel Pharmaceuticals,Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02040623
- Sponsor's protocol ID
- C-932348-004
- Acronym
- DROPS-2
- Status last verified
- Aug 2016
- First submitted
- 16 Jan 2014
- Last updated
- 10 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02040623
- Acronym / sponsor ID
- DROPS-2 / C-932348-004
- Conditions
- Chronic Graft-versus-host Disease
- Keywords
- Chronic Graft versus Host Disease, Keratoconjunctivitis Sicca
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Rigel PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 20 Jan 2014 (estimated)
- Results
- Posted 10 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| R348 Ophthalmic Solution, 0.2% | Active comparator | Drug: R348 Ophthalmic Solution, 0.2%R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day |
| R348 Ophthalmic Solution, 0.5% | Active comparator | Drug: R348 Ophthalmic Solution, 0.5%R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day |
| Placebo | Placebo comparator | Other: Placebo Ophthalmic SolutionPlacebo Ophthalmic Solution 2 drops per eye twice a day |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| R348 Ophthalmic Solution, 0.2%Also: R932348R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day | Drug | R348 Ophthalmic Solution, 0.2% |
| R348 Ophthalmic Solution, 0.5%Also: R932348R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day | Drug | R348 Ophthalmic Solution, 0.5% |
| Placebo Ophthalmic SolutionPlacebo Ophthalmic Solution 2 drops per eye twice a day | Other | Placebo |
Primary outcome
Change From Baseline (Visit 1) of Total Corneal Fluorescein Staining Score at 12 Weeks.
Time frame: Baseline to 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rigel Pharmaceuticals, Inc. study director
Rigel Pharmaceuticals,Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing R348 Ophthalmic Solution, 0.2% and R348 Ophthalmic Solution, 0.5% in people with Chronic Graft-versus-host Disease, run by Rigel Pharmaceuticals at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline (Visit 1) of Total Corneal Fluorescein Staining Score at 12 Weeks. (time frame: Baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2016.