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

NCT ID: NCT01494753

Last Updated: 2024-02-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2008-12-31

Brief Summary

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

Detailed Description

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Conditions

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Primary Open Angle Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Prostaglandin

One drop.

Group Type ACTIVE_COMPARATOR

Prostaglandin

Intervention Type DRUG

One drop at 8.00pm.

T2345

One drop

Group Type EXPERIMENTAL

T2345

Intervention Type DRUG

One drop at 8.00pm.

Interventions

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T2345

One drop at 8.00pm.

Intervention Type DRUG

Prostaglandin

One drop at 8.00pm.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Untreated bilateral newly diagnosed patients with primary open angle glaucoma

Exclusion Criteria

* Any ocular hypertension other than chronic open angle glaucoma
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laboratoires Thea

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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Aptel F, Choudhry R, Stalmans I. Preservative-free versus preserved latanoprost eye drops in patients with open-angle glaucoma or ocular hypertension. Curr Med Res Opin. 2016 Aug;32(8):1457-63. doi: 10.1080/03007995.2016.1202818. Epub 2016 Jun 25.

Reference Type DERIVED
PMID: 27310103 (View on PubMed)

Other Identifiers

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LT2345-PII-10/07(IN)

Identifier Type: -

Identifier Source: org_study_id

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