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CompletedNCT01900249DROPSUpdated Oct 3, 2016Results posted

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

A Phase 2 interventional study of R348 Ophthalmic Solution, 0.2% and R348 Ophthalmic Solution, 0.5% in Keratoconjunctivitis Sicca, sponsored by Rigel Pharmaceuticals. Completed at 20 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-10-03.

Sponsored by Rigel Pharmaceuticals · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
204
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Keratoconjunctivitis Sicca
03

In context

Keratoconjunctivitis Sicca

797 studies on the registry are indexed under Keratoconjunctivitis Sicca; 56 are open to participants now.

This study's enrollment of 204 is above the median of 73 across 674 interventional studies indexed under Keratoconjunctivitis Sicca.

Browse Keratoconjunctivitis Sicca studies →

Lead sponsor

Rigel Pharmaceuticals is the lead sponsor of 28 studies on the registry; 5 are open to participants now.

Browse Rigel Pharmaceuticals studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
204 participants (actual)

Study arms

  • Active comparator
    R348 Ophthalmic Solution, 0.2%

    R348 Ophthalmic Solution, 0.2%

    Drug: R348 Ophthalmic Solution, 0.2%

  • Active comparator
    R348 Ophthalmic Solution, 0.5%

    R348 Ophthalmic Solution, 0.5%

    Drug: R348 Ophthalmic Solution, 0.5%

  • Placebo comparator
    Placebo

    Placebo Ophthalmic Solution, 1 drop per eye twice a day for 12 weeks.

    Drug: Placebo

Interventions

  • DrugR348 Ophthalmic Solution, 0.2%

    R348 Ophthalmic Solution, 0.2% 1 drop per eye twice a day for 12 weeks.

    Also known as: R932348

  • DrugR348 Ophthalmic Solution, 0.5%

    R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks.

    Also known as: R932348

  • DrugPlacebo

    Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline to Week 12

07

Results

Posted Oct 3, 2016

Participant flow

Participant flow — Overall Study
MilestoneR348 Ophthalmic Solution, 0.2%R348 Ophthalmic Solution, 0.5%Placebo
Started676869
Completed646365
Not completed354

Outcome measures

PrimaryChange 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.

Time frame:
Baseline to Week 12
Reported as:
Mean · units on a scale (Likert)
Change of Corneal Fluorescein Staining of the Inferior Cornea Region.
units on a scale (Likert)R348 Ophthalmic Solution, 0.2%R348 Ophthalmic Solution, 0.5%Placebo
Change of Corneal Fluorescein Staining of the Inferior Cornea Region.-1.00 (-3.0 to 1.0)-0.78 (-2.5 to 1.0)-0.78 (-2.5 to 1.0)

Adverse events

Collected over The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
R348 Ophthalmic Solution, 0.2%—3/67 (4.5%)36/67 (53.7%)
R348 Ophthalmic Solution, 0.5%—1/68 (1.5%)46/68 (67.6%)
Placebo—2/69 (2.9%)31/69 (44.9%)
Most frequent serious events
Most frequent serious events
EventR348 Ophthalmic Solution, 0.2%R348 Ophthalmic Solution, 0.5%Placebo
Rectal haemorrhageGastrointestinal disorders1/670/680/69
Cerebrovascular accidentNervous system disorders1/670/680/69
PneumoniaInfections and infestations1/670/680/69
AsthmaRespiratory, thoracic and mediastinal disorders1/670/680/69
Malignant hyperthermiaGeneral disorders1/670/680/69
PancreatitisGastrointestinal disorders0/671/680/69
Chest painGeneral disorders0/670/681/69
Intervertebral disc protrusionMusculoskeletal and connective tissue disorders0/670/681/69
ArthralgiaMusculoskeletal and connective tissue disorders0/670/681/69
Most frequent other events
Showing 10 of 94
Most frequent other events
EventR348 Ophthalmic Solution, 0.2%R348 Ophthalmic Solution, 0.5%Placebo
Instillation Site PainGeneral disorders17/6735/683/69
Instillation Site DiscomfortGeneral disorders4/670/682/69
Instillation Site PruritusGeneral disorders1/674/680/69
Eye DischargeEye disorders3/673/682/69
Ocular HyperaemiaEye disorders3/670/681/69
NasopharyngitisInfections and infestations2/670/682/69
Conjunctival HyperaemiaEye disorders0/672/680/69
DiarrhoeaGastrointestinal disorders1/672/681/69
Urinary Track InfectionInfections and infestations1/672/681/69
InfluenzaInfections and infestations0/672/682/69

Baseline characteristics

Age, Continuous
Age, Continuous(Years)R348 Ophthalmic Solution, 0.2%R348 Ophthalmic Solution, 0.5%PlaceboTotal
Mean62.4 ± 11.5963.3 ± 11.561.5 ± 15.262.4 ± 12.8
Sex: Female, Male
Sex: Female, Male(Participants)R348 Ophthalmic Solution, 0.2%R348 Ophthalmic Solution, 0.5%PlaceboTotal
Female545454162
Male13141542
08

Study locations

20 sites
  • Sall Research Medical Center
    Artesia, California 90701, United States
  • North Bay Eye
    Petaluma, California 94954, United States
  • Martel Medical Eye Group
    Rancho Cardova, California 95670, United States
  • Specialty Eye Care
    Parker, Colorado 808134, United States
  • International Research Center
    Brandon, Florida 33603, United States
  • East Florida Eye Institute
    Stuart, Florida 34994, United States
  • Clayton Eye Center
    Morrow, Georgia 30260, United States
  • Coastal Research Associates
    Roswell, Georgia 30076, United States
  • Chicago Research Center
    Chicago, Illinois 60634, United States
  • Chicago Cornea Consultants
    Hoffman Estates, Illinois 60169, United States
  • Koffler Vision Group
    Lebanon, Kentucky 40033, United States
  • Taustine Eye Center
    Louisville, Kentucky 40217, United States
  • Comprehensive Eye Care, Ltd/Vision Research Institute, LLC
    Washington, Missouri 63090, United States
  • Mundorf Eye Center
    Charlotte, North Carolina 28204, United States
  • Charlotte Eye Ear Nose and Throat Associates, PA
    Charlotte, North Carolina 28210, United States
  • Cornerstone Eyecare
    High Point, North Carolina 27262, United States
  • Abrams Eye Center
    Cleveland, Ohio 44115, United States
  • Glaucoma Consultants and Center for Eye Research
    Mt. Pleasant, South Carolina 29464, United States
  • Chattanooga Eye Institute
    Chattanooga, Tennessee 37411, United States
  • Eye Clinics of South Texas
    San Antonio, Texas 78209, United States
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 3, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01900249
Lead sponsor
Rigel Pharmaceuticals
Responsible party
Sponsor
First posted
Jul 16, 2013
Start date
Jul 2013
Primary completion
Jul 2014
Completion
Jul 2014
Results posted
Oct 3, 2016
Last update
Oct 3, 2016

Study contacts

Daniel Magilavy, MD
study director · Rigel Pharmaceuticals,Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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