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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02829996
Other study ID # IPC-02-2015
Secondary ID
Status Completed
Phase Phase 2
First received July 8, 2016
Last updated January 19, 2018
Start date August 19, 2016
Est. completion date May 31, 2017

Study information

Verified date January 2018
Source Inotek Pharmaceuticals Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

This is a phase II, randomized, double-masked study to evaluate the efficacy and tolerability of topical ocular delivery of fixed-dose combinations of trabodenoson and latanoprost in subjects with OHT or POAG.

The Primary Objective of this Trial is to evaluate the efficacy of different topical ocular doses of trabodenoson (3.0% and 6.0%) when added to latanoprost (0.005% or 0.0025%), one drop daily to both eyes over two consecutive 4 week periods. The Secondary Objective is to evaluate the tolerability and safety of different doses of trabodenoson (3.0% and 6.0%) when added to latanoprost (0.005% or 0.0025%), one drop daily to both eyes over two consecutive 4 week periods. the Hypotheses is that topical ocular co-administration of 3.0% or 6.0% trabodenoson plus latanoprost 0.0025% or 0.005% ophthalmic formulation will reduce IOP and be well-tolerated.

All subjects who meet the study's enrollment criteria following Screening will undergo washout of all prohibited medications, including their routine glaucoma medications. During the Placebo Run-In Period, placebo (vehicle control matched to trabodenoson) 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 manner that is masked to the patient. The Treatment Period will be followed by an Observation Period of approximately 7 days wherein no study eye drops are instilled.

To mimic what is generally seen in clinical trials, the number of subjects with ocular hypertension as their diagnosis will be limited to approximately 30% of the total subjects enrolled. Additionally, so the trial mirrors the general population demographics (so as to improve generalizability of the results) the proportion of African American subjects will be approximately 25% or less but not less than 12% of the total subjects enrolled.

The purpose of the study is to assess the efficacy, tolerability, and safety of binocular topical application of different doses of trabodenoson (3.0% and 6.0%) when added to latanoprost (0.005% or 0.0025%) one drop daily over two consecutive 4 week periods in subjects with POAG or OHT. Data collection will include efficacy (masked-IOPs), local (ophthalmic) and systemic tolerability and safety assessments


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
trabodenoson 6.0% / latanoprost 0.005% QD
Trabodenoson 6.0% / latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.
trabodenoson 3.0% / latanoprost 0.005% QD
Trabodenoson 3.0% / latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.
trabodenoson 6.0% / latanoprost 0.0025% QD
Trabodenoson 6.0% / latanoprost 0.0025% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.
latanoprost 0.005% QD
Latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.
latanoprost 0.0025% QD
Latanoprost 0.0025% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.

Locations

Country Name City State
United States Inotek Pharmaceuticals Corporation Lexington Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Inotek Pharmaceuticals Corporation

Country where clinical trial is conducted

United States, 

Outcome

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
See also
  Status Clinical Trial Phase
Completed NCT02565173 - Study of Trabodenoson in Adults With Ocular Hypertension or Primary Open-angle Glaucoma Phase 3
Terminated NCT02226094 - Safety and Efficacy of Deep Wave Trabeculoplasty (DWT) in Primary Open Angle Glaucoma and Ocular Hypertension Phase 1/Phase 2
Recruiting NCT06016972 - Qlaris Phase 2 Study of QLS-111 in POAG and/or OHT Patients Phase 2
Completed NCT01318252 - AL-54478 Proof of Concept Study Phase 2
Terminated NCT01180062 - Safety Study of Latanoprost Slow Release Insert Phase 1
Completed NCT01917383 - A Phase II Study to Evaluate the Additivity of Trabodenoson to Latanoprost in Adults With Ocular Hypertension or Primary Open-Angle Glaucoma Phase 2
Completed NCT01670266 - Single and Multiple Dose Escalation and Two-sequence Crossover Study of ONO-9054 in Patients With Ocular Hypertension or Mild Open-angle Glaucoma Phase 1
Recruiting NCT06249152 - Qlaris Study of QLS-111 in Combination With a PGA for OAG and/or OHT Patients Phase 2