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NCT00471068 Clinical Trial

Study of Travatan and Cosopt in Primary Open-Angle Glaucoma or Ocular Hypertension

Ocular Hypertension Clinical Trial

Official title:
Study of Travatan and Cosopt in Primary Open-Angle Glaucoma or Ocular Hypertension

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00471068
Other study ID # EMD-05-03
Secondary ID
Status Terminated
Phase Phase 4
First received May 8, 2007
Last updated April 7, 2012
Start date March 2007

Study information
Verified date February 2010
Source Alcon Research
Contact n/a
Is FDA regulated No
Health authority Infarmed:Portugal
Study type Interventional

Clinical Trial Summary

To compare the efficacy and safety in patients treated with travoprost versus dorzolamide/timolol maleate combination in patients with open-angle glaucoma or ocular hypertension

Recruitment information / eligibility
Status Terminated
Enrollment 46
Est. completion date
Est. primary completion date August 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patient with open-angle glaucoma or ocular hypertension

Exclusion Criteria:

- By Age

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Travatan
Travatan: 6 weeks treatment with Travatan (travoprost 40 mg/ml eye drops, solution) once daily at 08:00 and placebo (timolol vehicle) once daily at 20:00 in the affected eye(s)
• Cosopt
treatment period of 6 weeks with Cosopt (dorzolamide 20 mg/ml and timolol maleate 5 mg/ml eye drops, solution) twice daily at 08:00 and 20:00 in the affected eye(s)
• Placebo (Timolol Vehicle)
Travatan group: 6 weeks treatment with Travatan (travoprost 40 mg/ml eye drops, solution) once daily at 08:00 and placebo (timolol vehicle) once daily at 20:00 in the affected eye(s)

Locations
Country Name City State
Portugal Coimbra Coimbra

Sponsors (1)
Lead Sponsor Collaborator
Alcon Research

Country where clinical trial is conducted

Portugal, 

Outcome
Type Measure Description Time frame Safety issue
Primary Intaocular Pressure (IOP) Mean Change After 6 Weeks of Treatment IOP measured at week 6 minus IOP measured at baseline At week 0 and week 6 Yes
See also
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Completed NCT01995136 - Investigation of Intraocular Pressure (IOP) Reduction Efficacy of Travoprost Ophthalmic Solution in Patients With Normal Tension Glaucoma Phase 4
Completed NCT01693315 - Multiple Dose-escalation Study of AMA0076 in Patients With Ocular Hypertension or Primary Open-angle Glaucoma Phase 2
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Active, not recruiting NCT01430923 - Clinical Evaluation of Safety and Efficacy of Refrigeration Free Latanoprost N/A
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Completed NCT01410188 - Safety/Efficacy Study: OPA-6566 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension Phase 1/Phase 2