GlaucomaPhase 4NCT02167035

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

A Phase 4 study testing Combigan Two Times Daily (BID) and Simbrinza Three Times Daily (TID) in people with Glaucoma and Ocular Hypertension, run by Cornerstone Health Care, PA at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Glaucoma, Ocular Hypertension
What is being tested?: Combigan Two Times Daily (BID) and Simbrinza Three Times Daily (TID)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 43 participants
Where: 1 siteUnited States
Study dates: Aug 2014to Mar 2018
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

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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 locations and contacts

1 site in 1 country.

United States1 site

Cornerstone Health Care
High Point, North Carolina, 27262

Other trials in United States

About this study

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

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
Being tested: Combigan Two Times Daily (BID), Simbrinza Three Times Daily (TID)
Keywords: Open-Angle Glaucoma, Ocular Hypertension
Medical subject headings: Glaucoma, Ocular Hypertension, Glaucoma, Open-Angle

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Combigan Two Times Daily (BID)Drug
Simbrinza Three Times Daily (TID)Drug

Study groups in NCT02167035
Study group	Role	What they receive
Combigan Two Times Daily (BID)	Active comparator	Combigan 0.2%/0.5% one drop Two Times Daily (BID) Receives: Drug: Combigan Two Times Daily (BID)
Simbrinza Three Times Daily (TID)	Active comparator	Simbrinza 1/0.2% one drop Three Times Daily (TID) Receives: Drug: Simbrinza Three Times Daily (TID)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2014Mar 2018

First posted18 Jun 2014 (estimated)
Study startAug 2014
Primary completionMar 2018
Study completionMar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for GlaucomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02167035
Sponsor's protocol ID: TEP001
Status last verified: Oct 2018
First submitted: 12 Jun 2014
Last updated: 24 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02167035
Acronym / sponsor ID: TEP001
Conditions: Glaucoma, Ocular Hypertension
Keywords: Open-Angle Glaucoma, Ocular Hypertension
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: Cornerstone Health Care, PAUniversity, hospital or other
Collaborators: Allergan
Study start: Aug 2014 (actual)
Primary completion: Mar 2018 (actual)
Study completion: Mar 2018 (actual)
First posted: 18 Jun 2014 (estimated)
Results: Posted 24 Oct 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Combigan Two Times Daily (BID)	Active comparator	Drug: Combigan Two Times Daily (BID)Combigan 0.2%/0.5% one drop Two Times Daily (BID)
Simbrinza Three Times Daily (TID)	Active comparator	Drug: Simbrinza Three Times Daily (TID)Simbrinza 1/0.2% one drop Three Times Daily (TID)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Combigan Two Times Daily (BID)	Drug	Combigan Two Times Daily (BID)
Simbrinza Three Times Daily (TID)	Drug	Simbrinza Three Times Daily (TID)

Primary outcome

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.

1 secondary outcome

Ocular Symptom and Tolerability Questionaire
Time frame: Baseline (Day 0), Visit 2 (Day 7), Visit 3 (Day 30), Visit 4 (Day 90)

Results and safety

Results posted to the registry on 24 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Combigan Two Times Daily (BID)	21	16
Simbrinza Three Times Daily (TID)	22	16

Primary outcome: 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). Mean (Standard Deviation). Unit: mmHg

Measure	Combigan BID n = 17	Simbrinza TID n = 19
Baseline 8am IOP	19.7 (5.33)	18.1 (3.31)
Baseline 10am IOP	19.1 (4.42)	18.8 (4.26)
Baseline 4pm IOP	17.6 (4.24)	17.6 (3.83)
Baseline Diurnal IOP	18.8 (4.42)	18.1 (3.53)
Visit 3 8am IOP	17.6 (4.47)	17.4 (2.26)
Visit 3 10am IOP	17.6 (3.08)	16.2 (2.52)
Visit 3 4pm IOP	17.1 (3.36)	17.6 (4.04)
Visit 3 Diurnal IOP	17.4 (3.12)	17.0 (2.51)

Population analysed: Primary endpoint analysis was conducted on the modified intent-to-treat (mITT) population, which consisted of all enrolled subjects randomized to masked study medication and who attended Visits 1,2,and 3 (minimally).

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were assessed from the time patients signed consent to their study exit, which was approximately 90 days for each patient.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Combigan BID	0 of 21 (0%)	3 of 21 (14.3%)	0 of 21
Simbrinza TID	0 of 22 (0%)	3 of 22 (13.6%)	0 of 22

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael E Tepedino, MD principal investigator

Cornerstone Health Care

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02167035.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2018.