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A 12week, Randomized, Evaluator-Masked, Parallel Group Comparing Evening Dosing Of Xalacom Vs Cosopt In Subj W/ Glaucoma

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Viatris

Status and phase

Completed
Phase 4

Conditions

Ocular Hypertension
Glaucoma, Open Angle

Treatments

Drug: Cosopt
Drug: Xalacom

Study type

Interventional

Funder types

Industry

Identifiers

NCT00140049
A6641038

Details and patient eligibility

About

To demonstrate the statistical non inferiority of the combination of latanoprost and timolol given in the evening time once a day vs the combination of dorzamalide and timolol twice a day based on intraocular pressure measurements at 8 AM, 12 noon & 4 PM during a 12 week treatment.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Uni- or bilateral diagnosis of primary open angle glaucoma or ocular hypertension on beta-blocker monotherapy or dual therapy in which at least one medication is a beta-blocker for at least 4 weeks prior to screening

Exclusion criteria

  • Closed/ barely open anterior chamber angle or history of acute angle closure glaucoma.
  • History of ALT (Argon Laser Trabeculoplasty) or SLT(selective Laser) within 3 months prior to screening

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

Trial contacts and locations

25

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Data sourced from clinicaltrials.gov

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