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CompletedNCT01646151Updated Jun 13, 2014Results posted

A Study Comparing IOP-Lowering Treatments to Bimatoprost in Patients With Primary Open Angle Glaucoma or Ocular Hypertension

An observational study in Glaucoma, Open-Angle and Ocular Hypertension, sponsored by Allergan. Completed at 2 sites in 2 countries. Per ClinicalTrials.gov, last updated 2014-06-13.

Sponsored by Allergan (part of AbbVie) · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,580
Sex
All
01

Study summary

An observational study comparing changing from an IOP-lowering treatment to a bimatoprost-containing IOP treatment in primary open-angle glaucoma (POAG) or ocular hypertension (OHT). Visits and treatment are per normal clinical practice.

02

Conditions studied

  • Glaucoma, Open-Angle
  • Ocular Hypertension
03

In context

Glaucoma, Open-Angle

943 studies on the registry are indexed under Glaucoma, Open-Angle; 118 are open to participants now.

This study's enrollment of 2,580 is above the median of 100 across 185 observational studies indexed under Glaucoma, Open-Angle.

Browse Glaucoma, Open-Angle studies →

Lead sponsor

Allergan is the lead sponsor of 505 studies on the registry; none are open to participants now.

Of its 93 completed or terminated interventional studies of FDA-regulated products, 91 (98%) have results posted.

First submitted before Allergan became part of AbbVie.

Browse Allergan studies →All AbbVie studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Subjects with POAG and OHT

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis of POAG or OHT
  • Previous use of IOP-lowering medication

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,580 participants (actual)

Groups and cohorts

  • Bimatoprost

    Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.

    Drug: Bimatoprost

Interventions

  • DrugBimatoprost

    Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.

    Also known as: LUMIGAN®, GANFORT®

06

What researchers measure

Primary outcomes

  1. Intraocular Pressure (IOP) at Baseline

    IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Baseline.

    Time frame: Baseline

  2. IOP at Week 12

    IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Week 12.

    Time frame: Week 12

Secondary outcomes

  1. Physician Evaluation of IOP Lowering in the Study Eye(s)

    IOP is a measurement of the fluid pressure inside the eye. Physicians evaluated IOP compared to the target IOP for each patient's study eye(s). The numbers of eyes in each category are presented.

    Time frame: Week 12

  2. Patient Assessment of Tolerability on a 4-Point Scale

    Patient assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.

    Time frame: Week 12

  3. Physician Assessment of Tolerability on a 4-Point Scale

    Physician assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.

    Time frame: Week 12

  4. Physician Assessment of Patient Compliance Compared to Previous Therapy

    Physician assessment of patient compliance compared to previous therapy was assessed on a 3-point scale (better, equal, and worse). The numbers of patients in each category are presented.

    Time frame: Week 12

  5. Percentage of Patients Who Discontinue Treatment With Bimatoprost-Containing Eye Drops Prior to 12 Weeks of Treatment

    Patients who discontinue treatment with bimatoprost-containing eye drops prior to 12 weeks of treatment was assessed as Yes or No.

    Time frame: 12 Weeks

  6. Percentage of Patients Who Continue Treatment With Bimatoprost-Containing Eye Drops

    Patients who will continue treatment with bimatoprost-containing eye drops after 12 weeks of treatment was assessed as Yes or No.

    Time frame: Week 12

07

Results

Posted Jun 13, 2014

Participant flow

Participant flow — Overall Study
MilestoneBimatoprost
Started2580
Completed2410
Not completed170

Outcome measures

PrimaryIntraocular Pressure (IOP) at Baseline

IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Baseline.

Time frame:
Baseline
Reported as:
Mean · Millimeters of Mercury (mmHg)
Intraocular Pressure (IOP) at Baseline
Millimeters of Mercury (mmHg)Bimatoprost
Right Eye20.51 ± 4.32
Left Eye (n=2091)20.65 ± 4.54
SecondaryPhysician Evaluation of IOP Lowering in the Study Eye(s)

IOP is a measurement of the fluid pressure inside the eye. Physicians evaluated IOP compared to the target IOP for each patient's study eye(s). The numbers of eyes in each category are presented.

Time frame:
Week 12
Reported as:
Number · Eyes
Physician Evaluation of IOP Lowering in the Study Eye(s)
EyesBimatoprost
IOP lower than target622
Target IOP reached1173
IOP decreased but target not reached467
IOP increased85
No change119
Data Missing205
SecondaryPatient Assessment of Tolerability on a 4-Point Scale

Patient assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.

Time frame:
Week 12
Reported as:
Number · Patients
Patient Assessment of Tolerability on a 4-Point Scale
PatientsBimatoprost
Very Good1127
Good1070
Moderate80
Poor70
SecondaryPhysician Assessment of Tolerability on a 4-Point Scale

Physician assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.

Time frame:
Week 12
Reported as:
Number · Patients
Physician Assessment of Tolerability on a 4-Point Scale
PatientsBimatoprost
Very Good1212
Good1059
Moderate74
Poor24
SecondaryPhysician Assessment of Patient Compliance Compared to Previous Therapy

Physician assessment of patient compliance compared to previous therapy was assessed on a 3-point scale (better, equal, and worse). The numbers of patients in each category are presented.

Time frame:
Week 12
Reported as:
Number · Patients
Physician Assessment of Patient Compliance Compared to Previous Therapy
PatientsBimatoprost
Better875
Equal1151
Worse51
Not Applicable36
SecondaryPercentage of Patients Who Discontinue Treatment With Bimatoprost-Containing Eye Drops Prior to 12 Weeks of Treatment

Patients who discontinue treatment with bimatoprost-containing eye drops prior to 12 weeks of treatment was assessed as Yes or No.

Time frame:
12 Weeks
Reported as:
Number · Percentage of Patients
Percentage of Patients Who Discontinue Treatment With Bimatoprost-Containing Eye Drops Prior to 12 Weeks of Treatment
Percentage of PatientsBimatoprost
Percentage of Patients Who Discontinue Treatment With Bimatoprost-Containing Eye Drops Prior to 12 Weeks of Treatment6.6
SecondaryPercentage of Patients Who Continue Treatment With Bimatoprost-Containing Eye Drops

Patients who will continue treatment with bimatoprost-containing eye drops after 12 weeks of treatment was assessed as Yes or No.

Time frame:
Week 12
Reported as:
Number · Percentage of Patients
Percentage of Patients Who Continue Treatment With Bimatoprost-Containing Eye Drops
Percentage of PatientsBimatoprost
Percentage of Patients Who Continue Treatment With Bimatoprost-Containing Eye Drops85.8
PrimaryIOP at Week 12

IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Week 12.

Time frame:
Week 12
Reported as:
Mean · Millimeters of Mercury (mmHg)
IOP at Week 12
Millimeters of Mercury (mmHg)Bimatoprost
Right Eye15.78 ± 2.85
Left Eye (n=2091)15.87 ± 3.19

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Bimatoprost—0/2,580 (0%)450/2,580 (17.4%)
Most frequent other events
Most frequent other events
EventBimatoprost
Conjunctival HyperaemiaEye disorders292/2580
Eye IrritationEye disorders158/2580

Baseline characteristics

Age, Customized
Age, Customized(Participants)Bimatoprost
<18 years0
18 to 30 years12
31 to 40 years20
41 to 50 years178
51 to 60 years403
61 to 70 years695
71 to 80 years883
81 to 90 years342
>=91 years19
Missing28
Sex/Gender, Customized
Sex/Gender, Customized(Participants)Bimatoprost
Female1454
Male1115
Missing11
08

Study locations

2 sites
  • Dresden, Germany
  • Amsterdam, Netherlands
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2012, a primary completion of Apr 2013 and a completion of Apr 2013. It does not say whether these dates are actual or estimated.

Results were first posted in Jun 2014, 1 year 2 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 18, 2012
First posted
Jul 20, 2012
Start
May 2012
Primary completionActual
Apr 2013
CompletionActual
Apr 2013
Results first posted
Jun 13, 2014
Last update
Jun 13, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 13, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01646151
Lead sponsor
Allergan
Responsible party
Sponsor
First posted
Jul 20, 2012
Start date
May 2012
Primary completion
Apr 2013
Completion
Apr 2013
Results posted
Jun 13, 2014
Last update
Jun 13, 2014

Study contacts

Medical Director
study director · Allergan

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.

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