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A Phase II Study to Evaluate the Additivity of Trabodenoson to Latanoprost in Adults With Ocular Hypertension or Primary Open-Angle Glaucoma

I

Inotek Pharmaceuticals

Status and phase

Completed
Phase 2

Conditions

Ocular Hypertension (OHT)
Primary Open-Angle Glaucoma (POAG)

Treatments

Drug: Latanoprost
Drug: Trabodenoson
Drug: Timolol

Study type

Interventional

Funder types

Industry

Identifiers

NCT01917383
IPC-01-2013

Details and patient eligibility

About

The purpose of this study is to evaluate the intraocular pressure (IOP) lowering efficacy and the safety and tolerability profile of trabodenoson ophthalmic formulation compared to timolol maleate ophthalmic solution 0.5% in adults with ocular hypertension (OHT) or primary open-angle glaucoma (POAG) who are already receiving treatment with latanoprost ophthalmic solution 0.005% once every evening (QPM).

Full description

Criteria

Inclusion Criteria:

  1. Subject has signed and dated the current informed consent form (ICF).
  2. Subject has the diagnosis of ocular hypertension (OHT) or primary open-angle glaucoma (POAG) (excluding secondary, pseudo-exfoliation, and pigment dispersion glaucomas).
  3. Aged 18 or older.
  4. Mean intraocular pressure (IOP) of ≥24 and ≤34 mm Hg.

Exclusion Criteria:

  1. No significant visual field loss or any new field loss within the past year.
  2. Cup-to-disc ratio ≥0.8
  3. Central corneal thickness <500 µm or >600 µm
  4. A recent (acute) or chronic medical condition that might obfuscate the Subject's study data

Enrollment

101 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Subject has signed and dated the current informed consent form (ICF).
  2. Subject has the diagnosis of ocular hypertension (OHT) or primary open-angle glaucoma (POAG) (excluding secondary, pseudo-exfoliation, and pigment dispersion glaucomas).
  3. Aged 18 or older.
  4. Mean intraocular pressure (IOP) of ≥24 and ≤34 mm Hg.

Exclusion criteria

  1. No significant visual field loss or any new field loss within the past year.
  2. Cup-to-disc ratio ≥0.8
  3. Central corneal thickness <500 µm or >600 µm
  4. A recent (acute) or chronic medical condition that might obfuscate the Subject's study data

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

101 participants in 2 patient groups

Trabodenoson Plus Latanoprost
Experimental group
Description:
Experimental ophthalmic eye drop plus a prostaglandin analogue eye drop
Treatment:
Drug: Trabodenoson
Drug: Latanoprost
Timolol Plus Latanoprost
Active Comparator group
Description:
A Beta-blocker eye drop plus a prostaglandin analogue eye drop
Treatment:
Drug: Timolol
Drug: Latanoprost

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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