CClinicalTrials.gg
Sign In
CompletedNCT01001195Updated Oct 18, 2013Results posted

Safety and Efficacy of Three Formulations of AGN-210669 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution

A Phase 2 interventional study of AGN-210669 ophthalmic solution, 0.1% and AGN-210669 ophthalmic solution, 0.075% in Glaucoma, Open-Angle 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 2013-10-18.

Sponsored by Allergan · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
165
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study will evaluate the safety, efficacy and dose-response of AGN-210669. This study will also compare AGN-210669 with bimatoprost ophthalmic solution (LUMIGAN®).

02

Conditions studied

  • Glaucoma, Open-Angle
  • Ocular Hypertension
03

In context

Ocular Hypertension

649 studies on the registry are indexed under Ocular Hypertension; 48 are open to participants now.

This study's enrollment of 165 is above the median of 120 across 510 interventional studies indexed under Ocular Hypertension.

Browse Ocular Hypertension 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

Inclusion criteria

  • Ocular hypertension or primary open-angle glaucoma in each eye
  • Patient requires IOP lowering medication in each eye

Exclusion criteria

Exclusion Criteria:

  • Ocular hyperemia or other ocular surface findings in either eye
  • Active ocular disease
  • Current or anticipated use of any topical ocular medication (including artificial tears) during the study
  • Intraocular surgery within past six months or unilateral cataract surgery.
  • Functionally significant visual field loss
  • Anticipated wearing of contact lenses during study
  • Use of other medications that affect IOP such as glaucoma treating medications, within 2 months of screening visit
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
165 participants (actual)

Study arms

  • Experimental
    AGN-210669 ophthalmic solution, 0.1%

    One drop of AGN-210669 ophthalmic solution, 0.1% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.

    Drug: AGN-210669 ophthalmic solution, 0.1%

  • Experimental
    AGN-210669 ophthalmic solution, 0.075%

    One drop of AGN-210669 ophthalmic solution, 0.075% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.

    Drug: AGN-210669 ophthalmic solution, 0.075%

  • Experimental
    AGN-210669 ophthalmic solution, 0.05%

    One drop of AGN-210669 ophthalmic solution, 0.05% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.

    Drug: AGN-210669 ophthalmic solution, 0.05%

  • Active comparator
    bimatoprost ophthalmic solution 0.03%

    One drop of bimatoprost ophthalmic solution 0.03% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.

    Drug: bimatoprost ophthalmic solution 0.03%

Interventions

  • DrugAGN-210669 ophthalmic solution, 0.1%

    One drop of AGN-210669 ophthalmic solution, 0.1% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.

  • DrugAGN-210669 ophthalmic solution, 0.075%

    One drop of AGN-210669 ophthalmic solution, 0.075% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.

  • DrugAGN-210669 ophthalmic solution, 0.05%

    One drop of AGN-210669 ophthalmic solution, 0.05% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.

  • Drugbimatoprost ophthalmic solution 0.03%

    One drop of bimatoprost ophthalmic solution 0.03% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.

    Also known as: LUMIGAN®

06

What researchers measure

Primary outcomes

  1. Change From Baseline in Average Eye Intraocular Pressure (IOP)

    IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes is used for the analyses. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening).

    Time frame: Baseline, Day 29 Hour 0

07

Results

Posted Oct 18, 2013

Participant flow

Participant flow — Overall Study
MilestoneAGN-210669 Ophthalmic Solution, 0.1%AGN-210669 Ophthalmic Solution, 0.075%AGN-210669 Ophthalmic Solution, 0.05%Bimatoprost Ophthalmic Solution 0.03%
Started39414441
Completed37394441
Not completed2200

Outcome measures

PrimaryChange From Baseline in Average Eye Intraocular Pressure (IOP)

IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes is used for the analyses. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening).

Time frame:
Baseline, Day 29 Hour 0
Reported as:
Mean · Millimeters of Mercury (mmHg)
Change From Baseline in Average Eye Intraocular Pressure (IOP)
Millimeters of Mercury (mmHg)AGN-210669 Ophthalmic Solution, 0.1%AGN-210669 Ophthalmic Solution, 0.075%AGN-210669 Ophthalmic Solution, 0.05%Bimatoprost Ophthalmic Solution 0.03%
Baseline - Hour 025.88 ± 3.69625.18 ± 2.38225.39 ± 2.77025.73 ± 3.490
Change from Baseline at Day 29 - Hour 0-7.50 ± 4.219-7.65 ± 3.171-5.66 ± 3.082-8.57 ± 3.854

Adverse events

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

Adverse event summary by group
GroupDeathsSeriousOther
AGN-210669 Ophthalmic Solution, 0.1%—1/39 (2.6%)28/39 (71.8%)
AGN-210669 Ophthalmic Solution, 0.075%—0/41 (0%)35/41 (85.4%)
AGN-210669 Ophthalmic Solution, 0.05%—0/44 (0%)23/44 (52.3%)
Bimatoprost Ophthalmic Solution 0.03%—0/41 (0%)29/41 (70.7%)
Most frequent serious events
Most frequent serious events
EventAGN-210669 Ophthalmic Solution, 0.1%AGN-210669 Ophthalmic Solution, 0.075%AGN-210669 Ophthalmic Solution, 0.05%Bimatoprost Ophthalmic Solution 0.03%
CholecystitisHepatobiliary disorders1/390/410/440/41
Most frequent other events
Most frequent other events
EventAGN-210669 Ophthalmic Solution, 0.1%AGN-210669 Ophthalmic Solution, 0.075%AGN-210669 Ophthalmic Solution, 0.05%Bimatoprost Ophthalmic Solution 0.03%
Conjunctival HyperaemiaEye disorders21/3923/4113/4425/41
Punctate KeratitisEye disorders5/393/414/443/41
PhotophobiaEye disorders4/395/412/441/41
Vision BlurredEye disorders2/395/412/441/41
Eye PainEye disorders3/394/410/441/41
Foreign Body Sensation in EyesEye disorders2/394/410/441/41
Eye PruritusEye disorders0/391/411/443/41
Anterior Chamber CellEye disorders2/391/411/440/41
Eye IrritationEye disorders2/391/410/442/41
Instillation Site PainGeneral disorders2/391/410/441/41

Baseline characteristics

Age, Customized
Age, Customized(Participants)AGN-210669 Ophthalmic Solution, 0.1%AGN-210669 Ophthalmic Solution, 0.075%AGN-210669 Ophthalmic Solution, 0.05%Bimatoprost Ophthalmic Solution 0.03%Total
<45 years11204
45 to 65 years2224212188
>65 years1616212073
Sex: Female, Male
Sex: Female, Male(Participants)AGN-210669 Ophthalmic Solution, 0.1%AGN-210669 Ophthalmic Solution, 0.075%AGN-210669 Ophthalmic Solution, 0.05%Bimatoprost Ophthalmic Solution 0.03%Total
Female2422231887
Male1519212378
08

Study locations

1 site
  • Rochester, New York, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 18, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01001195
Lead sponsor
Allergan
Responsible party
Sponsor
First posted
Oct 26, 2009
Start date
Nov 2009
Primary completion
Apr 2010
Completion
Apr 2010
Results posted
Oct 18, 2013
Last update
Oct 18, 2013

Study contacts

Medical Director
study director · Allergan

Oversight

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

Not currently enrolling

This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Ocular Hypertension→

Other studies from this sponsor

Allergan

Start the discussion