CClinicalTrials.gg
CompletedNCT00716742Updated Jan 6, 2012Results posted

Safety and Efficacy Study of Bimatoprost, Latanoprost, and Travoprost in Patients With Elevated Intraocular Pressure (IOP) and Open-angle Glaucoma (OAG)

An observational study in Open-Angle Glaucoma and Ocular Hypertension, sponsored by Allergan. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-01-06.

Sponsored by Allergan · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,099
Ages
18 Years and older
Sex
All
01

Study summary

To investigate the effectiveness of the newer IOP-lowering therapies, as prescribed in normal clinical practice, in larger patient numbers. Patients will be assessed at baseline, at each follow-up visit (follow-up visits are variable as per physician discretion) and at final follow-up visit.

02

Conditions studied

  • Open-Angle Glaucoma
  • Ocular Hypertension
03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's enrollment of 1,099 is above the median of 103 across 454 observational studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Allergan is the lead sponsor of 499 studies on the registry; none are open to participants now.

Of its 91 completed or terminated interventional studies of FDA-regulated products, 89 (98%) have results posted.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients can be either: (a) newly diagnosed and require, in the judgment of the treating physician, one of study agents as first-line treatment, (b) have an insufficiently controlled IOP on their current medication (any but not more than two in combination), and a treatment switch to one of study agents is an acceptable option.

Inclusion criteria

  • A diagnosis of Primary Open-Angle Glaucoma or Ocular Hypertension newly diagnosed OR presenting with insufficiently controlled IOP on current medication (in the opinion of the treating physician)
  • Patient is having both eyes treated

Exclusion criteria

Exclusion Criteria:

  • Contraindications per product labelling will apply.
  • Patients with any ophthalmic co-morbidity with an influence on visual field deterioration or optic nerve head damage.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,099 participants (actual)

Groups and cohorts

  • 1

    bimatoprost 0.03% latanoprost 0.005% travoprost 0.004%

    Drug: bimatoprost 0.03%, latanoprost 0.005%, and travoprost 0.004%

Interventions

  • Drugbimatoprost 0.03%, latanoprost 0.005%, and travoprost 0.004%

    1 drop in eye(s) every evening

    Also known as: Lumigan®, Xalatan®, Travatan®

06

What researchers measure

Primary outcomes

  1. Change From Baseline in Bilateral Intraocular Pressure (IOP) at One Year

    Change from baseline in bilateral (both eyes) IOP at the 1 year follow-up visit. IOP is a measure of the fluid pressure inside the eye. The bilateral IOP was calculated as an average between both eye's IOP. A negative number change from baseline indicates reduction in IOP (improvement).

    Time frame: Baseline, 1 Year

07

Results

Posted Jan 6, 2012
Limitations and caveats
Data for 2-year and 3-year follow-up not interpretable due to extremely high drop out rates.

Participant flow

Baseline
Participant flow — Baseline
MilestoneLumigan®Travatan®Xalatan®
Started364370365
Completed347356352
Not completed171413
1 Year Follow-up
Participant flow — 1 Year Follow-up
MilestoneLumigan®Travatan®Xalatan®
Started347356352
Completed160163152
Not completed187193200
2 Year Follow-up
Participant flow — 2 Year Follow-up
MilestoneLumigan®Travatan®Xalatan®
Started160163152
Completed566750
Not completed10496102
3 Year Follow-up
Participant flow — 3 Year Follow-up
MilestoneLumigan®Travatan®Xalatan®
Started566750
Completed263529
Not completed303221

Outcome measures

PrimaryChange From Baseline in Bilateral Intraocular Pressure (IOP) at One Year

Change from baseline in bilateral (both eyes) IOP at the 1 year follow-up visit. IOP is a measure of the fluid pressure inside the eye. The bilateral IOP was calculated as an average between both eye's IOP. A negative number change from baseline indicates reduction in IOP (improvement).

Time frame:
Baseline, 1 Year
Reported as:
Mean · Millimeters of mercury (mmHg)
Change From Baseline in Bilateral Intraocular Pressure (IOP) at One Year
Millimeters of mercury (mmHg)Lumigan®Travatan®Xalatan®
Baseline20.8 ± 5.220.3 ± 5.020.6 ± 5.2
Change from Baseline at 1 Year-4.8 ± 3.3-4.3 ± 2.7-4.3 ± 2.9

Adverse events

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

Adverse event summary by group
GroupDeathsSeriousOther
Lumigan®—5/364 (1.4%)0/364 (0%)
Travatan®—2/370 (0.5%)0/370 (0%)
Xalatan®—6/365 (1.6%)0/365 (0%)
Most frequent serious events
Most frequent serious events
EventLumigan®Travatan®Xalatan®
DeathGeneral disorders5/3642/3706/365

Baseline characteristics

Age Continuous
Age Continuous(years)Lumigan®Travatan®Xalatan®Total
Median65.5 (21 to 97)67.0 (32 to 98)67.0 (23 to 95)67.0 (21 to 98)
Sex: Female, Male
Sex: Female, Male(Participants)Lumigan®Travatan®Xalatan®Total
Female210206201617
Male154164164482
08

Study locations

1 site
  • Murfreesboro, Tennessee, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00716742
Lead sponsor
Allergan
Responsible party
Sponsor
First posted
Jul 16, 2008
Start date
Sep 2004
Primary completion
Sep 2007
Completion
Sep 2009
Results posted
Jan 6, 2012
Last update
Jan 6, 2012

Study contacts

Medical Director
study director · Allergan
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.

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