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

Cornerstone Health Care, PA

Status and phase: Completed; Phase 4

Conditions: Glaucoma; Ocular Hypertension

Treatments: Drug: Simbrinza Three Times Daily (TID); Drug: Combigan Two Times Daily (BID)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02167035

TEP001

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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43 participants in 2 patient groups

Combigan Two Times Daily (BID)

Active Comparator group

Description:

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

Treatment:

Drug: Combigan Two Times Daily (BID)

Simbrinza Three Times Daily (TID)

Active Comparator group

Description:

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

Treatment:

Drug: Simbrinza Three Times Daily (TID)