Open Angle Glaucoma -Ocular HypertensionPhase 1NCT02531152
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
A Phase 1 study testing Latanoprost and SAR366234 in people with Open Angle Glaucoma -Ocular Hypertension, run by Sanofi at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Angle Glaucoma -Ocular Hypertension
- What is being tested?
- Latanoprost and SAR366234
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 5 sitesUnited States
- Study dates
- Sep 2015to Apr 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Investigational Site Number 840003
Cape Coral, Florida, 33904
Investigational Site Number 840001
Inglewood, California, 90301
Investigational Site Number 840002
Memphis, Tennessee, 38119
Investigational Site Number 840005
Roswell, Georgia, 30076
Investigational Site Number 840004
Saint Joseph, Michigan, 49085
About this study
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
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.
Read the 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.
- Conditions
- Open Angle Glaucoma -Ocular Hypertension
- Being tested
- Latanoprost, SAR366234
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LatanoprostDrug
Also called Xalatan
SAR366234Drug
| Study group | Role | What they receive |
|---|---|---|
| SAR366234 (Dose 1) | Experimental | A low dose of SAR366234 will be administered 2 drops per eye per day for 28 days Receives: Drug: SAR366234 |
| SAR366234 (Dose 2) | Experimental | A medium dose of SAR366234 will be administered 1 drop per eye per day for 28 days Receives: Drug: SAR366234 |
| SAR366234 (Dose 3) | Experimental | A medium dose of SAR366234 will be administered 2 drops per eye per day for 28 days Receives: Drug: SAR366234 |
| SAR366234 (Dose 4) | Experimental | A high dose of SAR366234 will be administered 1 drop per eye per day for 28 days Receives: Drug: SAR366234 |
| SAR366234 (Dose 5) | Experimental | A high dose of SAR366234 will be administered 2 drops per eye per day for 28 days Receives: Drug: SAR366234 |
| Latanoprost | Active comparator | A dose of Latanoprost will be administered 1 drop per eye per day for 28 days Receives: Drug: Latanoprost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events (including local tolerance and ophthalmological examinations)
Measured: From screening (Day -42) up to approximately Day 39
Secondary outcomes (1)
Assessment of IOP using Goldman applanation tonometry
Measured: From screening (Day -42) up to approximately Day 39
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Angle Glaucoma -Ocular HypertensionStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02531152
- Sponsor's protocol ID
- TDR13459
- Other IDs
- U1111-1153-3544
- Status last verified
- Apr 2016
- First submitted
- 20 Aug 2015
- Last updated
- 27 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02531152
- Acronym / sponsor ID
- TDR13459
- Conditions
- Open Angle Glaucoma -Ocular Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 24 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| SAR366234 (Dose 1) | Experimental | Drug: SAR366234A low dose of SAR366234 will be administered 2 drops per eye per day for 28 days |
| SAR366234 (Dose 2) | Experimental | Drug: SAR366234A medium dose of SAR366234 will be administered 1 drop per eye per day for 28 days |
| SAR366234 (Dose 3) | Experimental | Drug: SAR366234A medium dose of SAR366234 will be administered 2 drops per eye per day for 28 days |
| SAR366234 (Dose 4) | Experimental | Drug: SAR366234A high dose of SAR366234 will be administered 1 drop per eye per day for 28 days |
| SAR366234 (Dose 5) | Experimental | Drug: SAR366234A high dose of SAR366234 will be administered 2 drops per eye per day for 28 days |
| Latanoprost | Active comparator | Drug: LatanoprostA dose of Latanoprost will be administered 1 drop per eye per day for 28 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (24 listed)
- 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.
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 |
|---|---|---|
| LatanoprostAlso: Xalatan | Drug | Latanoprost |
| SAR366234 | Drug | SAR366234 (Dose 1), SAR366234 (Dose 2), SAR366234 (Dose 3), SAR366234 (Dose 4), SAR366234 (Dose 5) |
Primary outcome
Number of adverse events (including local tolerance and ophthalmological examinations)
Time frame: From screening (Day -42) up to approximately Day 39
1 secondary outcome
Assessment of IOP using Goldman applanation tonometry
Time frame: From screening (Day -42) up to approximately Day 39
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2016.
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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.
Clinical Sciences & Operations study director
Sanofi
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Latanoprost and SAR366234 in people with Open Angle Glaucoma -Ocular Hypertension, run by Sanofi at 5 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 16 inclusion and 24 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 27 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of adverse events (including local tolerance and ophthalmological examinations) (time frame: From screening (Day -42) up to approximately Day 39). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2016; AzTrials last refreshed its copy on 3 Nov 2026.