Ocular Hypertension (OHT) Clinical Trial
Official title:
Phase II, Randomized, Double-masked, Active-controlled Study of Fixed-Dose Combinations of Trabodenoson and Latanoprost in Subjects With Ocular Hypertension or Primary Open-Angle Glaucoma
Verified date | January 2018 |
Source | Inotek Pharmaceuticals Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Phase II, randomized, double-masked study to evaluate the efficacy and tolerability of
topical ocular delivery of fixed-dosed combinations of trabodenoson and latanoprost in
subjects with Ocular Hypertension or Primary Open-Angle Glaucoma.
All subjects who meet the study's enrollment criteria following Screening will undergo
washout of all prohibited medications (if washout is needed), including their routine
glaucoma medications. During the Placebo Run-In Period, placebo is applied twice daily to
both eyes in all subjects. During the Treatment Period, study drug is applied to both eyes
for a total of 8 weeks. Each subject will be assigned 4 weeks of AM and 4 weeks of PM dosing
in a masked manner. AM vs PM dosing is masked utilizing Placebo in addition to the active
drug product. During the Treatment Period, study drug (Active and Placebo) eye drop
applications will occur twice daily, in the morning and in the evening. The Treatment Period
will be followed by an Observation Period of approximately 7 days wherein no study eye drops
are instilled.
The purpose of the study is to assess the overall benefit/risk profile of binocular topical
application of different doses of trabodenoson (3.0% and 6.0%) when combined with latanoprost
(0.005% or 0.0025%) one drop daily (QD) for 8 weeks.
Status | Completed |
Enrollment | 201 |
Est. completion date | May 31, 2017 |
Est. primary completion date | May 24, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Diagnosis of ocular hypertension (OHT) or primary open-angle glaucoma (POAG) - Mean Intraocular pressure (IOP) of =25 and =34 Exclusion Criteria: - Significant visual field loss or any new field loss within the past year - Cup-to-disc ratio >0.8 - Central corneal thickness <490 µm or >610 µm - A recent (acute) or chronic medical condition that might obfuscate the Subject's study data |
Country | Name | City | State |
---|---|---|---|
United States | Inotek Pharmaceuticals Corporation | Lexington | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Inotek Pharmaceuticals Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Safety Parameters, Including Treatment Emergent Adverse Events, to Assess Tolerability and Safety. | Collection of safety parameters, including treatment emergent adverse events, laboratory assessments, to assess tolerability and safety. | Through Study Completion, up to 9 weeks. | |
Primary | Mean Intraocular Pressure (IOP) | Daily change from diurnal baseline in IOP | Two Months |
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