Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    TDR13459
Previous Study | Return to List | Next Study

28-Day Repeated Topical Study to Evaluate the Safety and Activity of 5 Escalating Dose Levels of SAR366234 and One Dose of Latanoprost in Patients With Open Angle Glaucoma or Ocular Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02531152
Recruitment Status : Completed
First Posted : August 24, 2015
Last Update Posted : April 27, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE August 20, 2015
First Posted Date  ICMJE August 24, 2015
Last Update Posted Date April 27, 2016
Study Start Date  ICMJE September 2015
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2015)
Number of adverse events (including local tolerance and ophthalmological examinations) [ Time Frame: From screening (Day -42) up to approximately Day 39 ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 20, 2015)
Number of adverse events (including local tolerance and ophthalmological examinations) [ Time Frame: From screening (Day -36) up to approximately Day 39 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2015)
Assessment of IOP using Goldman applanation tonometry [ Time Frame: From screening (Day -42) up to approximately Day 39 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2015)
Assessment of IOP using Goldman applanation tonometry [ Time Frame: From screening (Day -36) up to approximately Day 39 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 28-Day Repeated Topical Study to Evaluate the Safety and Activity of 5 Escalating Dose Levels of SAR366234 and One Dose of Latanoprost in Patients With Open Angle Glaucoma or Ocular Hypertension
Official Title  ICMJE A Randomized, Observer-masked Study of the Safety, Tolerability and Pharmacodynamics of Sequential Ascending 28-Day Repeated Topical Doses of SAR366234 Versus Latanoprost in Patients With Open Angle Glaucoma or Ocular Hypertension
Brief Summary

Primary Objective:

To assess the local and systemic safety and tolerability of ascending repeated topical doses of SAR366234 monotherapy in patients with open angle glaucoma (OAG) or ocular hypertension (OHT) as compared to latanoprost.

Secondary Objective:

To assess the pharmacodynamic activity of ascending repeated topical doses of SAR366234 in patients with OAG or OHT as compared to latanoprost.

Detailed Description

The total study duration for one patient is up to 11 weeks, including a screening period of up to 6 weeks run-in (depending on washout requirements), a 4-week treatment period, and a 1-week follow-up period.

The study design is also a parallel cohort study to assess the safety, tolerability, and pharmacodynamic activity of SAR366234.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Open Angle Glaucoma -Ocular Hypertension
Intervention  ICMJE
  • Drug: Latanoprost
    Other Name: Xalatan
  • Drug: SAR366234
Study Arms  ICMJE
  • Experimental: SAR366234 (Dose 1)
    A low dose of SAR366234 will be administered 2 drops per eye per day for 28 days
    Intervention: Drug: SAR366234
  • Experimental: SAR366234 (Dose 2)
    A medium dose of SAR366234 will be administered 1 drop per eye per day for 28 days
    Intervention: Drug: SAR366234
  • Experimental: SAR366234 (Dose 3)
    A medium dose of SAR366234 will be administered 2 drops per eye per day for 28 days
    Intervention: Drug: SAR366234
  • Experimental: SAR366234 (Dose 4)
    A high dose of SAR366234 will be administered 1 drop per eye per day for 28 days
    Intervention: Drug: SAR366234
  • Experimental: SAR366234 (Dose 5)
    A high dose of SAR366234 will be administered 2 drops per eye per day for 28 days
    Intervention: Drug: SAR366234
  • Active Comparator: Latanoprost
    A dose of Latanoprost will be administered 1 drop per eye per day for 28 days
    Intervention: Drug: Latanoprost
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 26, 2016)
54
Original Estimated Enrollment  ICMJE
 (submitted: August 20, 2015)
75
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • Male or female patients ≥18 years of age.
  • Patients diagnosed with OAG (including pseudoexfoliation and pigment dispersion syndromes and patients with a history of narrow angle closure with a patent peripheral iridotomy) or OHT.
  • Documented intraocular pressure (IOP) fulfilling the eligibility criteria (below) at both the screening and baseline visits:
  • At the screening visit
  • an IOP ≤21 mmHg in both eyes if currently treated with an IOP-lowering medication or
  • an IOP ≥22 mmHg and <36 mmHg if treatment-naïve or not on IOP lowering medication for at least 5 weeks.
  • At the baseline visit following washout
  • an IOP ≥22 mmHg and <36 mmHg at about 8:00 am,
  • an IOP >20 mmHg and <36 mmHg at about 12:00 noon, and
  • an IOP >18 mmHg and <36 mmHg at about 4:00 pm.
  • Baseline laboratory parameters within the defined screening threshold for the Investigator site, unless the Investigator considers and documents an abnormality to be clinically irrelevant.
  • Having given written informed consent prior to undertaking any study-related procedure, including stopping their current glaucoma treatment, if any, and engaging into the corresponding washout procedures.
  • Patients should agree to discontinue any concomitant topical ocular medication(s) and current IOP-reducing agents.
  • Best corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity score of +1.0 logMAR (Snellen equivalent 20/200) or better in both eyes at the screening and baseline visits.
  • Patients on systemic β blockers must be on a stable dose for at least 2 weeks before screening and should expect to continue the treatment during the study with no anticipated alteration in the medication dose.
  • Patients should agree to discontinue contact lenses during treatment with the study medication.

Exclusion criteria:

  • Any clinically significant disease or concomitant medication that would interfere with the study evaluation.
  • Patients with advanced glaucoma at risk of progression during the study in the opinion of the Investigator.
  • Presence or history of hypersensitivity to latanoprost or known history of non-response to any prostaglandin analog given for the reduction of IOP.
  • History of hypersensitivity or allergy to any component of the investigational medicinal product or any of the diagnostic medications or materials used in the conduct of the study.
  • Use or expected need for ocular (topical, periocular, or intravitreal), local (inhaled or nasal), or systemic glucocorticoid medications within 4 weeks prior to the baseline visit and for the duration of the study.
  • Any vaccination within the last 28 days from randomization or during screening whichever is longer.
  • Any patient in the exclusion period of a previous study according to applicable regulations.
  • Any patient who cannot be contacted in case of emergency.
  • Any patient who is the Investigator or any subinvestigator, research assistant, pharmacist, study coordinator, or other staff thereof, directly involved in conducting the study.
  • Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab).
  • Positive result on urine drug screen (amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates) unless the result of a medical prescription.
  • An IOP ≥36 mmHg at any time during the screening, baseline, or randomization visits (Day 1 predose).
  • History of ocular surgery (including laser) or trauma in either eye within 6 months of the screening visit.
  • History of glaucoma filtering surgery or aqueous shunt procedures (traditional valves and/or microinvasive glaucoma surgery [MIGs]).
  • History of ocular infection within the past 3 months or ongoing or recurrent ocular inflammation (ie, moderate to severe blepharitis, allergic conjunctivitis, herpetic keratitis, peripheral ulcerative keratitis, scleritis, or uveitis) in either eye. Any ocular abnormalities or symptoms indicative of ongoing ophthalmic disease (except if related to glaucoma or OHT).
  • Central corneal thickness <500 µm or >620 µm at the baseline visit.
  • Any evidence of cornea guttata or corneal endothelial dysfunction from medical history or at the baseline visit.
  • Uncontrolled disease that would interfere with the study conduct, the interpretation of the study results, or the ability of the patient to meet the requirements of the study schedule.
  • Any corneal abnormalities preventing reliable applanation tonometry.
  • Closed/barely open anterior chamber angle or a history of acute angle closure in either eye not adequately treated with a peripheral iridectomy.
  • Diagnosis of a clinically significant or progressive retinal disease (eg, diabetic retinopathy, advanced age-related macular degeneration, inherited retinal dystrophies) in either eye.
  • Advanced optic nerve abnormality or history of visual field loss in either eye based on the assessment of the Investigator which could put the patient at risk of glaucoma progression by participating in the study.
  • History of aphakia, pseudophakia with a torn posterior lens capsule, macular edema, or known risk factors for macular edema in either eye.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02531152
Other Study ID Numbers  ICMJE TDR13459
U1111-1153-3544 ( Other Identifier: UTN )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP