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

NCT02167035 | Completed Phase 4 Results

• 1 other identifier: TEP001
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glaucoma; Ocular Hypertension

Keywords

Open-Angle Glaucoma; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Ocular Symptom and Tolerability Questionaire

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

Study Arms (2)

Combigan Two Times Daily (BID)

ACTIVE COMPARATOR

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

Drug: Combigan Two Times Daily (BID)

Simbrinza Three Times Daily (TID)

ACTIVE COMPARATOR

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

Drug: Simbrinza Three Times Daily (TID)

Interventions

Combigan Two Times Daily (BID) DRUG

Combigan Two Times Daily (BID)

Simbrinza Three Times Daily (TID) DRUG

Simbrinza Three Times Daily (TID)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cornerstone Health Care, PA: lead
• Allergan: collaborator

Study Sites (1)

Cornerstone Health Care

High Point, North Carolina, 27262, United States

Location

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension; Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Eye Diseases

Limitations and Caveats

The Local IRB closed in the middle of this trial which resulted in the discontinuation of 6 subjects. A new IRB was obtained and the study was re-opened and completed.

Results Point of Contact

• Title: Michael Tepedino, MD
• Organization: Cornerstone Healthcare

mtepedino@wakehealth.edu

336-802-2255

Study Officials

• Michael E Tepedino, MD

  Cornerstone Health Care

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Research

Study Record Dates

• First Submitted: June 12, 2014
• First Posted: June 18, 2014
• Study Start: August 1, 2014
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: October 24, 2018
• Results First Posted: October 24, 2018

Record last verified: 2018-10

Locations

US (1)