Phase 4
Completed N=43
Comparison of Combigan Two Times Daily (BID) Versus Simbrinza Three Times Daily (TID)
Source: ClinicalTrials.gov NCT02167035 ↗Enrolled (actual)
43
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcomePrimary: Intraocular Pressure — 19.7; 18.1; 19.1; 18.8 mmHg
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intraocular Pressure |
19.7; 18.1; 19.1; 18.8; 17.6; 17.6 | — |
| SECONDARY Ocular Symptom and Tolerability Questionaire |
0.1; 0.1; 0.1; 0.1; 0.3; 0.4 | — |
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT02167035). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.