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

NCT02531152 | Completed Phase 1

• 2 other identifiers: TDR13459U1111-1153-3544
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 5

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.

Conditions

Open Angle Glaucoma -Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• Number of adverse events (including local tolerance and ophthalmological examinations)

  From screening (Day -42) up to approximately Day 39

Secondary Outcomes (1)

• Assessment of IOP using Goldman applanation tonometry

  From screening (Day -42) up to approximately Day 39

Study Arms (6)

SAR366234 (Dose 1)

EXPERIMENTAL

A low dose of SAR366234 will be administered 2 drops per eye per day for 28 days

Drug: SAR366234

SAR366234 (Dose 2)

EXPERIMENTAL

A medium dose of SAR366234 will be administered 1 drop per eye per day for 28 days

Drug: SAR366234

SAR366234 (Dose 3)

EXPERIMENTAL

A medium dose of SAR366234 will be administered 2 drops per eye per day for 28 days

Drug: SAR366234

SAR366234 (Dose 4)

EXPERIMENTAL

A high dose of SAR366234 will be administered 1 drop per eye per day for 28 days

Drug: SAR366234

SAR366234 (Dose 5)

EXPERIMENTAL

A high dose of SAR366234 will be administered 2 drops per eye per day for 28 days

Drug: SAR366234

Latanoprost

ACTIVE COMPARATOR

A dose of Latanoprost will be administered 1 drop per eye per day for 28 days

Drug: Latanoprost

Interventions

Latanoprost DRUG

Also known as: Xalatan

Latanoprost

SAR366234 DRUG

SAR366234 (Dose 1); SAR366234 (Dose 2); SAR366234 (Dose 3); SAR366234 (Dose 4); SAR366234 (Dose 5)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (5)

Investigational Site Number 840001

Inglewood, California, 90301, United States

Location

Investigational Site Number 840003

Cape Coral, Florida, 33904, United States

Location

Investigational Site Number 840005

Roswell, Georgia, 30076, United States

Location

Investigational Site Number 840004

Saint Joseph, Michigan, 49085, United States

Location

Investigational Site Number 840002

Memphis, Tennessee, 38119, United States

Location

MeSH Terms

Interventions

Latanoprost

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2015
• First Posted: August 24, 2015
• Study Start: September 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 27, 2016

Record last verified: 2016-04

Locations

US (5)