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

Glaucoma Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02167035
• Other study ID #: TEP001
• Status: Completed
• Phase: Phase 4
• Start date: August 2014
• Est. completion date: March 2018

Study information

• Verified date: October 2018
• Source: Cornerstone Health Care, PA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Hypertension
• Ocular Hypertension

Intervention

Drug:
• Combigan Two Times Daily (BID)

• Simbrinza Three Times Daily (TID)

Locations

Country	Name	City	State
United States	Cornerstone Health Care	High Point	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Cornerstone Health Care, PA	Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular Pressure	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.	Day 0 (08:00, 10:00 16:00), Day 30 (08:00, 10:00, 16:00), Day 90 (08:00, 10:00,16:00)
Secondary	Ocular Symptom and Tolerability Questionaire	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.	Baseline (Day 0), Visit 2 (Day 7), Visit 3 (Day 30), Visit 4 (Day 90)