Keratoconjunctivitis SiccaPhase 2DROPSNCT01900249

To Assess the Safety and Efficacy of R932348 Ophthalmic Solutions in Patients With Keratoconjunctivitis Sicca

A Phase 2 study testing R348 Ophthalmic Solution, 0.2% and R348 Ophthalmic Solution, 0.5% in people with Keratoconjunctivitis Sicca, run by Rigel Pharmaceuticals at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine whether 0.2% and 0.5% R348 Ophthalmic Solutions are safe and effective in the treatment of Patients with Keratoconjunctivitis Sicca. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Keratoconjunctivitis Sicca
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: 204 participants
Where: 20 sitesUnited States
Study dates: Jul 2013to Jul 2014
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

A history of dry eye (based on the date of initial dry eye symptoms)
Use of over-the-counter (OTC) and/or prescription eye drops for dry eye symptoms
Corneal fluorescein staining score of at least 2 in the inferior region

Who cannot join

History of, or a concurrent clinically significant illness, medical condition (other than Keratoconjunctivitis Sicca or Sjögren's syndrome), or laboratory abnormality that, in the Investigator's opinion, could affect the conduct of the study.
Use of ophthalmic cyclosporine within 45 days of Visit 1.
Use of any topical ophthalmic steroid within 2 weeks of Visit 1.
Have worn contact lenses or anticipate using contact lenses during the study.
Have a condition or be in a situation that the Investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.
Have a history of alcohol or substance abuse that, in the judgment of the Investigator, may impair or risk the subject's full participation in the study.

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

United States20 sites

Sall Research Medical Center
Artesia, California, 90701
International Research Center
Brandon, Florida, 33603
Mundorf Eye Center
Charlotte, North Carolina, 28204
Charlotte Eye Ear Nose and Throat Associates, PA
Charlotte, North Carolina, 28210
Chattanooga Eye Institute
Chattanooga, Tennessee, 37411
Chicago Research Center
Chicago, Illinois, 60634
Abrams Eye Center
Cleveland, Ohio, 44115
Cornerstone Eyecare
High Point, North Carolina, 27262
Chicago Cornea Consultants
Hoffman Estates, Illinois, 60169
Koffler Vision Group
Lebanon, Kentucky, 40033
Taustine Eye Center
Louisville, Kentucky, 40217
Clayton Eye Center
Morrow, Georgia, 30260
Glaucoma Consultants and Center for Eye Research
Mt. Pleasant, South Carolina, 29464
Specialty Eye Care
Parker, Colorado, 808134
North Bay Eye
Petaluma, California, 94954
Martel Medical Eye Group
Rancho Cardova, California, 95670
Coastal Research Associates
Roswell, Georgia, 30076
Eye Clinics of South Texas
San Antonio, Texas, 78209
East Florida Eye Institute
Stuart, Florida, 34994
Comprehensive Eye Care, Ltd/Vision Research Institute, LLC
Washington, Missouri, 63090

Other trials in United States

About this study

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 in Patients With Keratoconjunctivitis Sicca

The purpose of this study is to determine whether 0.2% and 0.5% R348 Ophthalmic Solutions are safe and effective in the treatment of Patients with Keratoconjunctivitis Sicca.

Conditions: Keratoconjunctivitis Sicca
Being tested: R348 Ophthalmic Solution, 0.2%, R348 Ophthalmic Solution, 0.5%, Placebo
Medical subject headings: 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% 1 drop per eye twice a day for 12 weeks.
R348 Ophthalmic Solution, 0.5%Drug
Also called R932348
R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks.
PlaceboDrug
Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks.

Study groups in NCT01900249
Study group	Role	What they receive
R348 Ophthalmic Solution, 0.2%	Active comparator	R348 Ophthalmic Solution, 0.2% Receives: Drug: R348 Ophthalmic Solution, 0.2%
R348 Ophthalmic Solution, 0.5%	Active comparator	R348 Ophthalmic Solution, 0.5% Receives: Drug: R348 Ophthalmic Solution, 0.5%
Placebo	Placebo comparator	Placebo Ophthalmic Solution, 1 drop per eye twice a day for 12 weeks. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change of Corneal Fluorescein Staining of the Inferior Cornea Region.
Change from baseline (Visit 3) of inferior region CFS score at 12 weeks. Inferior region CFS score range 0-4, where '0' represents no fluorescein staining and '4' represents severe staining on the cornea.
Measured: Baseline to Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2013Jul 2014

First posted16 Jul 2013 (estimated)
Study startJul 2013
Primary completionJul 2014
Study completionJul 2014

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 Keratoconjunctivitis SiccaStudies 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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 204 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01900249
Sponsor's protocol ID: C-932348-003
Acronym: DROPS
Status last verified: Aug 2016
First submitted: 11 Jul 2013
Last updated: 3 Oct 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Keratoconjunctivitis Sicca trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

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 in Patients With Keratoconjunctivitis Sicca
ClinicalTrials.gov ID: NCT01900249
Acronym / sponsor ID: DROPS / C-932348-003
Conditions: Keratoconjunctivitis Sicca
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 204 participants (actual)
Lead sponsor: Rigel PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Jul 2013
Primary completion: Jul 2014 (actual)
Study completion: Jul 2014 (actual)
First posted: 16 Jul 2013 (estimated)
Results: Posted 3 Oct 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to determine whether 0.2% and 0.5% R348 Ophthalmic Solutions are safe and effective in the treatment of Patients with Keratoconjunctivitis Sicca.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, 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%
R348 Ophthalmic Solution, 0.5%	Active comparator	Drug: R348 Ophthalmic Solution, 0.5%R348 Ophthalmic Solution, 0.5%
Placebo	Placebo comparator	Drug: PlaceboPlacebo Ophthalmic Solution, 1 drop per eye twice a day for 12 weeks.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

A history of dry eye (based on the date of initial dry eye symptoms)
Use of over-the-counter (OTC) and/or prescription eye drops for dry eye symptoms
Corneal fluorescein staining score of at least 2 in the inferior region

Key exclusion criteria (6 listed)

History of, or a concurrent clinically significant illness, medical condition (other than Keratoconjunctivitis Sicca or Sjögren's syndrome), or laboratory abnormality that, in the Investigator's opinion, could affect the conduct of the study.
Use of ophthalmic cyclosporine within 45 days of Visit 1.
Use of any topical ophthalmic steroid within 2 weeks of Visit 1.
Have worn contact lenses or anticipate using contact lenses during the study.
Have a condition or be in a situation that the Investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.

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% 1 drop per eye twice a day for 12 weeks.	Drug	R348 Ophthalmic Solution, 0.2%
R348 Ophthalmic Solution, 0.5%Also: R932348R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks.	Drug	R348 Ophthalmic Solution, 0.5%
PlaceboPlacebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks.	Drug	Placebo

Primary outcome

Change of Corneal Fluorescein Staining of the Inferior Cornea Region.
Time frame: Baseline to Week 12
Change from baseline (Visit 3) of inferior region CFS score at 12 weeks. Inferior region CFS score range 0-4, where '0' represents no fluorescein staining and '4' represents severe staining on the cornea.

Results and safety

Results posted to the registry on 3 Oct 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
R348 Ophthalmic Solution, 0.2%	67	64
R348 Ophthalmic Solution, 0.5%	68	63
Placebo	69	65

Primary outcome: Change of Corneal Fluorescein Staining of the Inferior Cornea Region.

Time frame: Baseline to Week 12. Mean (95% Confidence Interval). Unit: units on a scale (Likert)

Measure	R348 Ophthalmic Solution, 0.2% n = 67	R348 Ophthalmic Solution, 0.5% n = 68	Placebo n = 69
Value	-1.00 (-3.0 to 1.0)	-0.78 (-2.5 to 1.0)	-0.78 (-2.5 to 1.0)

Population analysed: The intent to treat population (ITT) included all randomized subjects who administered study medication. The primary analysis was performed on the ITT population.

Adverse events

Time frame: The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
R348 Ophthalmic Solution, 0.2%	3 of 67 (4.5%)	36 of 67 (53.7%)	Not reported
R348 Ophthalmic Solution, 0.5%	1 of 68 (1.5%)	46 of 68 (67.6%)	Not reported
Placebo	2 of 69 (2.9%)	31 of 69 (44.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 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.

Daniel Magilavy, MD study director

Rigel Pharmaceuticals,Inc.

20 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 Keratoconjunctivitis Sicca, run by Rigel Pharmaceuticals at 20 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 3 inclusion and 6 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 3 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 20 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 3 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 of Corneal Fluorescein Staining of the Inferior Cornea Region. (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01900249.

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 3 Oct 2016.