Pharmacokinetics, Efficacy and Safety Assessment of T2345 Compared With Active Comparator in Newly Diagnosed Patients With Open-angle Glaucoma or Ocular Hypertension

Thea Pharma

Status and phase: Completed; Phase 2

Conditions: Primary Open Angle Glaucoma

Treatments: Drug: Prostaglandin; Drug: T2345

Study type: Interventional

Funder types: Industry

Identifiers

NCT01494753

LT2345-PII-10/07(IN)

Details and patient eligibility

About

The purpose of this study is to assess the pharmacokinetics, efficacy and safety of T2345 versus an active comparator.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Untreated bilateral newly diagnosed patients with primary open angle glaucoma

Exclusion criteria

• Any ocular hypertension other than chronic open angle glaucoma

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Prostaglandin

Active Comparator group

Description:

One drop.

Treatment:

Drug: Prostaglandin

T2345

Experimental group

Description:

One drop

Treatment:

Drug: T2345