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NCT Number: NCT02167035

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

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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Key information

Conditions

Glaucoma Eye Diseases Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cornerstone Health Care

High Point, North Carolina, 27262, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Combigan Two Times Daily (BID)

Drug

Simbrinza Three Times Daily (TID)

Drug

Primary outcomes

  1. Intraocular Pressure

    Time frame: Day 0 (08:00, 10:00 16:00), Day 30 (08:00, 10:00, 16:00), Day 90 (08:00, 10:00,16:00)

    The Intraocular Pressure will be assessed on study subjects. IOP (Intraocular Pressure) will be measured using a Goldmann applanation tonometer. Both eyes will be tested, with the right eye preceding the left eye. The operator will initially set the dial at 10 mmHg, then look through the slit lamp and adjust the dial to take the reading, and then record the results. The procedure will be repeated on the same eye twice consecutively. If the measurements are within 2mmHg or less of each other, the mean of the 2 reading will be reported as the IOP at that time point. If the 2 reading are more than 2mmHg apart from each other, a third (consecutive) reading will be taken and the median (middle) IOP will be reported as the IOP at that time point. Preferable, the same operator will measure IOP and the same tonometer will be used at each visit.

Secondary outcomes

  1. Ocular Symptom and Tolerability Questionaire

    Time frame: Baseline (Day 0), Visit 2 (Day 7), Visit 3 (Day 30), Visit 4 (Day 90)

    The secondary endpoint of this study was to determine the tolerability of each treatment group by utilizing ocular symptom questionnaires administered at each study visit. These questionnaires assessed Oral effects (bad taste, dry mouth) and Ocular comfort effects (itching, burning, stinging, burning on instillation, blurred vision). The scale proved was none=0, mild=1, moderate=2, severe=3.

Sponsors and collaborators

Lead sponsor

Cornerstone Health Care, PA

Other

Collaborators

  • Allergan

Registry information

Official study title

Pilot Study Comparison of Combigan Two Times Daily (BID) vs Simbrinza Three Times Daily (TID) in Subjects Currently Treated With Latanoprost For Open-Angle Glaucoma or Ocular Hypertension

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jun 18, 2014
Registry last updated
Oct 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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