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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

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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

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.


Condition or disease Intervention/treatment Phase
Open Angle Glaucoma -Ocular Hypertension Drug: Latanoprost Drug: SAR366234 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Latanoprost

Arm Intervention/treatment
Experimental: SAR366234 (Dose 1)
A low dose of SAR366234 will be administered 2 drops per eye per day for 28 days
Drug: SAR366234
Experimental: SAR366234 (Dose 2)
A medium dose of SAR366234 will be administered 1 drop per eye per day for 28 days
Drug: SAR366234
Experimental: SAR366234 (Dose 3)
A medium dose of SAR366234 will be administered 2 drops per eye per day for 28 days
Drug: SAR366234
Experimental: SAR366234 (Dose 4)
A high dose of SAR366234 will be administered 1 drop per eye per day for 28 days
Drug: SAR366234
Experimental: SAR366234 (Dose 5)
A high dose of SAR366234 will be administered 2 drops per eye per day for 28 days
Drug: SAR366234
Active Comparator: Latanoprost
A dose of Latanoprost will be administered 1 drop per eye per day for 28 days
Drug: Latanoprost
Other Name: Xalatan




Primary Outcome Measures :
  1. Number of adverse events (including local tolerance and ophthalmological examinations) [ Time Frame: From screening (Day -42) up to approximately Day 39 ]

Secondary Outcome Measures :
  1. Assessment of IOP using Goldman applanation tonometry [ Time Frame: From screening (Day -42) up to approximately Day 39 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02531152


Locations
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United States, California
Investigational Site Number 840001
Inglewood, California, United States, 90301
United States, Florida
Investigational Site Number 840003
Cape Coral, Florida, United States, 33904
United States, Georgia
Investigational Site Number 840005
Roswell, Georgia, United States, 30076
United States, Michigan
Investigational Site Number 840004
St Joseph, Michigan, United States, 49085
United States, Tennessee
Investigational Site Number 840002
Memphis, Tennessee, United States, 38119
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02531152    
Other Study ID Numbers: TDR13459
U1111-1153-3544 ( Other Identifier: UTN )
First Posted: August 24, 2015    Key Record Dates
Last Update Posted: April 27, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Latanoprost
Antihypertensive Agents