Comparison of Combigan Two Times Daily (BID) Versus Simbrinza Three Times Daily (TID)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2018-03-31

Brief Summary

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To compare Combigan Two Times Daily (BID) vs Simbrinza Three Times Daily (TID) in subjects currently being treated with Latanoprost for Open-Angle Glaucoma or Ocular Hypertension. Both of these drugs are currently FDA approved as combination therapy for patients with Open-Angle Glaucoma or Ocular Hypertension. The purpose of this clinical trial would be to assess which treatment, if either, is superior in lowering intraocular pressure (IOP). A secondary objective is to assess the tolerability of each drug.

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Detailed Description

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Conditions

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Glaucoma Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Combigan Two Times Daily (BID)

Combigan 0.2%/0.5% one drop Two Times Daily (BID)

Group Type ACTIVE_COMPARATOR

Combigan Two Times Daily (BID)

Intervention Type DRUG

Simbrinza Three Times Daily (TID)

Simbrinza 1/0.2% one drop Three Times Daily (TID)

Group Type ACTIVE_COMPARATOR

Simbrinza Three Times Daily (TID)

Intervention Type DRUG

Interventions

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Combigan Two Times Daily (BID)

Intervention Type DRUG

Simbrinza Three Times Daily (TID)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Open-angle glaucoma or ocular Hypertension
* Currently treated with Latanoprost for min of 6 weeks
* Male or Female 18 yrs and older
* Best Corrected Visual Acuity 20/100 or better in both eyes
* Pachymetry \>470 and \< 640
* Women of childbearing potential must have a negative urine pregnancy test at the screening/baseline visit
* Patient willing and capable of providing informed consent

Exclusion Criteria

* C/D \> 0.8
* Visual field loss, which in the opinion of the investigator is functionally significant
* Current use of ocular steroids
* Concurrent significant active ocular disease History (within 3 months prior to Screening) of ocular laser, intraocular, filtering or refractive surgery or planned ocular surgery of any kind during study participation
* Change within prior 30 days or anticipated change in any systemic medication that is known to affect IOP
* Uncontrolled systemic disease
* Significant ocular hyperemia at baseline
* Prior glaucoma procedure within 3 months
* Females who are pregnant, nursing, or planning a pregnancy or who are of childbearing potential and not using a reliable method of contraception
* Known allergy or sensitivity to any study medication
* Asthma or any other known medical condition that the investigator feels would put patient at increased risk from any of the study medications
* Current enrollment in an investigational drug or device study or participation in such a study within 30 days prior to Screening

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes