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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03150160
Other study ID # CQVJ499A2404
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 21, 2017
Est. completion date December 4, 2017

Study information

Verified date October 2018
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study was to determine the incremental intraocular pressure (IOP) lowering that is achieved when Simbrinza is used adjunctively to Travatan in patients with normal tension glaucoma that may benefit from further IOP lowering.


Description:

This study was prematurely terminated due to administrative reasons and not due to any safety or efficacy concerns.


Recruitment information / eligibility

Status Completed
Enrollment 1
Est. completion date December 4, 2017
Est. primary completion date December 4, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Sign written informed consent

- Diagnosed with normal tension glaucoma

- Intraocular pressure measurements in at least 1 eye as specified in the protocol

- Willing and able to attend all study visits

Exclusion Criteria:

- History of hypersensitivity to any of the study drugs

- Use of medications prohibited by the protocol

- Pregnant or nursing

- Of child-bearing potential unless using contraception, as specified in the protocol

- Any form of glaucoma other than open angle glaucoma in either eye

- Chronic, recurrent or severe inflammatory eye disease

- Ocular trauma or surgery within the past 6 months in either eye; ocular infection or laser surgery within the past 3 months in either eye (all from screening)

- Conditions which would make the patient, in the opinion of the Investigator, unsuitable for the study.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
brinzolamide 1%/brimonidine 0.2% fixed combination
One drop applied topically to the affected eye(s) in the morning and evening
Placebo
One drop applied topically to the affected eye(s) in the morning and evening
travoprost 0.004% ophthalmic solution
One drop applied topically to the affected eye(s) in the evening

Locations

Country Name City State
Korea, Republic of Novartis Investigative Site Seoul

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean Change From Baseline in Diurnal IOP at Week 6 IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry in millimeters mercury (mmHg). Diurnal IOP was defined as the average of the 9:00 am and 11:00 am time points. A more negative change value indicates a greater amount of improvement. One eye (study eye) contributed to the analysis. Baseline, Week 6
Secondary Percent Change From Baseline in IOP at Week 6 IOP was measured by Goldmann applanation tonometry in mmHg. A more negative percent change value indicates a greater amount of improvement. One eye (study eye) contributed to the analysis. Baseline, Week 6
Secondary Mean Diurnal IOP at Week 6 IOP was measured by Goldmann applanation tonometry in mmHg. Diurnal IOP was defined as the average of the 9:00 and 11:00 time points. One (study eye) contributed to the analysis. Week 6
Secondary Mean Change From Baseline in IOP for Each Time Point at Week 6 IOP was measured by Goldmann applanation tonometry in mmHg. A more negative change value indicates a greater amount of improvement. One eye (study eye) contributed to the analysis. Baseline (9:00 am and 11:00 am), Week 6 (9:00 am and 11:00 am)
Secondary Percentage Change From Baseline in IOP for Each Time Point at Week 6 IOP was measured by Goldmann applanation tonometry in mmHg. A more negative percent change value indicates a greater amount of improvement. One eye (study eye) contributed to the analysis. Baseline, Week 6
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