NCT01915940

Brief Summary

The objective of this Phase 2 study is to evaluate whether the Bimatoprost Ocular Insert is non-inferior to that of timolol ophthalmic solution (0.5%) at 12 weeks.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
169

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 5, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

October 23, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2014

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

April 20, 2018

Completed
Last Updated

April 20, 2018

Status Verified

March 1, 2018

Enrollment Period

11 months

First QC Date

July 31, 2013

Results QC Date

March 22, 2018

Last Update Submit

March 22, 2018

Conditions

Primary Open-Angle GlaucomaOcular Hypertension

Keywords

GlaucomaPrimary Open-Angle GlaucomaOcular Hypertension

Outcome Measures

Primary Outcomes (3)

  • Change From Baseline in Intra-Ocular Pressure (IOP) at Week 2

    IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (time (T)=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 2. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement.

    Baseline (Day 0) to Week 2

  • Change From Baseline in Intra-Ocular Pressure (IOP) at Week 6

    IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 6. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement.

    Baseline (Day 0) to Week 6

  • Change From Baseline in Intra-Ocular Pressure (IOP) at Week 12

    IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 12. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement.

    Baseline (Day 0) to Week 12

Secondary Outcomes (3)

  • Change From Baseline in IOP at Month 4

    Baseline (Day 1) to Month 4

  • Change From Baseline in IOP at Month 5

    Baseline (Day 0) to Month 5

  • Change From Baseline in IOP at Month 6

    Baseline (Day 0) to Month 6

Study Arms (2)

13 mg Bimatoprost Ocular Insert

EXPERIMENTAL

Washout and placebo ocular insert in each eye for at least 4 weeks, followed by 13 mg Bimatoprost Ocular Insert in each eye and placebo eye drops twice a day in each eye for 6 months.

Drug: BimatoprostDrug: Placebo Eye DropsDevice: Placebo Ocular Insert

Timolol 0.5% + Placebo Ocular Insert

ACTIVE COMPARATOR

Washout and placebo ocular insert in each eye for at least 4 weeks, followed by Timolol (timoptic ophthalmic solution 0.5%) twice a day in each eye plus placebo ocular insert for 6 months.

Drug: Timolol 0.5%Device: Placebo Ocular Insert

Interventions

BimatoprostDRUG

Bimatoprost ocular insert

13 mg Bimatoprost Ocular Insert
Timolol 0.5%DRUG

Timolol 0.5% solution

Also known as: timoptic
Timolol 0.5% + Placebo Ocular Insert
Placebo Eye DropsDRUG

Placebo topical eye drops

13 mg Bimatoprost Ocular Insert
Placebo Ocular InsertDEVICE

Ocular insert without any active drug

Also known as: non-medicated (placebo) Ocular Insert
13 mg Bimatoprost Ocular InsertTimolol 0.5% + Placebo Ocular Insert

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent
  • Primary open-angle glaucoma or ocular hypertension in both eyes
  • Best-corrected distance vision of 20/80 or better
  • Stable visual field
  • corneal thickness between 490-620 micrometers

You may not qualify if:

  • Cup-to-disc ratio greater than 0.8
  • significant risk of angle closure due to pupil dilation, defined as a Shaffer classification of less than grade 2 based on gonioscopy
  • laser surgery for glaucoma/ocular hypertension on one or both eyes within the last 12 months
  • past history of corneal refractive surgery
  • past history of any incisional surgery for glaucoma at any time
  • corneal abnormalities that would interfere with tonometry readings
  • current participation in an investigational drug or device study or participation in such a study within 30 days of screening
  • Inability to accurately evaluate the retina

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Sall Medical Research Center

Artesia, California, 90701, United States

Location

Scripps Clinic Torrey Pines

La Jolla, California, 92037, United States

Location

Eye Research Foundation

Newport Beach, California, 92663, United States

Location

UC Davis Dept of Ophthalmology & Vision Science

Sacramento, California, 95817, United States

Location

Coastal Research Associates

Atlanta, Georgia, 30076, United States

Location

Clayton Eye Center

Morrow, Georgia, 30260, United States

Location

Ophthalmology Consultants

St Louis, Missouri, 63131, United States

Location

UNC Kittner Eye Center

Chapel Hill, North Carolina, 27517, United States

Location

Apex Eye

Madeira, Ohio, 45243, United States

Location

Ophthalmology Associates PC

Fort Worth, Texas, 76102, United States

Location

Related Publications (1)

  • Belamkar A, Harris A, Zukerman R, Siesky B, Oddone F, Verticchio Vercellin A, Ciulla TA. Sustained release glaucoma therapies: Novel modalities for overcoming key treatment barriers associated with topical medications. Ann Med. 2022 Dec;54(1):343-358. doi: 10.1080/07853890.2021.1955146.

    PMID: 35076329DERIVED

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular HypertensionGlaucoma

Interventions

BimatoprostTimolol

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

AmidesOrganic ChemicalsCloprostenolProstaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological FactorsPropanolaminesAmino AlcoholsAlcoholsPropanolsAminesThiadiazolesThiazolesSulfur CompoundsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMorpholinesOxazines

Results Point of Contact

Title
Therapeutic Area Head,
Organization
Allergan, Inc
clinicaltrials@allergan.com
714-246-4500

Study Officials

  • Michelle Chen, PhD

    Allergan

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2013

First Posted

August 5, 2013

Study Start

October 23, 2013

Primary Completion

September 30, 2014

Study Completion

November 14, 2014

Last Updated

April 20, 2018

Results First Posted

April 20, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

US(10)