Primary Open-Angle GlaucomaPhase 2NCT01915940

Bimatoprost Ocular Insert Compared to Topical Timolol Solution in Patients With Glaucoma or Ocular Hypertension

A Phase 2 study testing Bimatoprost and Timolol 0.5% in people with Primary Open-Angle Glaucoma and Ocular Hypertension, run by ForSight Vision5, Inc. at 10 sites in United States.

Completed

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

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Primary Open-Angle Glaucoma, Ocular Hypertension
What is being tested?: Bimatoprost and Timolol 0.5%
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 169 participants
Where: 10 sitesUnited States
Study dates: 23 Oct 2013to 14 Nov 2014
Phase: Phase 2
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
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

Sall Medical Research Center
Artesia, California, 90701
Coastal Research Associates
Atlanta, Georgia, 30076
UNC Kittner Eye Center
Chapel Hill, North Carolina, 27517
Ophthalmology Associates PC
Fort Worth, Texas, 76102
Scripps Clinic Torrey Pines
La Jolla, California, 92037
Apex Eye
Madeira, Ohio, 45243
Clayton Eye Center
Morrow, Georgia, 30260
Eye Research Foundation
Newport Beach, California, 92663
UC Davis Dept of Ophthalmology & Vision Science
Sacramento, California, 95817
Ophthalmology Consultants
St Louis, Missouri, 63131

Other trials in United States

About this study

Official title: A Phase 2, Multicenter, Randomized, Subject- and Examiner-masked, Controlled Clinical Trial Designed to Evaluate the Safety and Effectiveness of the Bimatoprost Ocular Insert as Compared to Topical Timolol Solution (0.5%) in Patients With Glaucoma or Ocular Hypertension.

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.

Conditions: Primary Open-Angle Glaucoma, Ocular Hypertension
Being tested: Bimatoprost, Timolol 0.5%, Placebo Eye Drops, Placebo Ocular Insert
Keywords: Glaucoma, Primary Open-Angle Glaucoma, Ocular Hypertension
Medical subject headings: Glaucoma, Open-Angle, Ocular Hypertension, Glaucoma

What participants receive

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

BimatoprostDrug
Bimatoprost ocular insert
Timolol 0.5%Drug
Also called timoptic
Timolol 0.5% solution
Placebo Eye DropsDrug
Placebo topical eye drops
Placebo Ocular InsertDevice
Also called non-medicated (placebo) Ocular Insert
Ocular insert without any active drug

Study groups in NCT01915940
Study group	Role	What they receive
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. Receives: Drug: Bimatoprost; Drug: Placebo Eye Drops; Device: 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. Receives: Drug: Timolol 0.5%; Device: Placebo Ocular Insert

What is being measured

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

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.
Measured: 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.
Measured: 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.
Measured: Baseline (Day 0) to Week 12

Secondary outcomes (3)

Change From Baseline in IOP at Month 4
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 Month 4. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement.
Measured: Baseline (Day 1) to Month 4
Change From Baseline in IOP at Month 5
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 Month 5. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement.
Measured: Baseline (Day 0) to Month 5
Change From Baseline in IOP at Month 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 Month 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.
Measured: Baseline (Day 0) to Month 6

Timeline

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

23 Oct 201314 Nov 2014

First posted5 Aug 2013 (estimated)
Study start23 Oct 2013
Primary completion30 Sep 2014
Study completion14 Nov 2014

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Primary Open-Angle 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 169 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01915940
Sponsor's protocol ID: FSV5-002
Status last verified: Mar 2018
First submitted: 31 Jul 2013
Last updated: 20 Apr 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 35076329

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

Active, not recruiting
OMNI 3.1 Surgical System in Subjects With Primary Open-Angle Glaucoma
Primary Open Angle Glaucoma
Not yet recruiting
Evaluation the Safety and Effectiveness of the GORE GDI in Adult Subjects With Primary Open-angle Glaucoma in Whom Previous Medical and Surgical Treatment Have Failed.
Glaucoma, Primary Open Angle
Not yet recruitingPhase 4
The Effect of Lumify™ on Ocular Redness, Intraocular Pressure, and Eyelid Position in Glaucoma Patients
Glaucoma, Glaucoma, Open-Angle
Not yet recruitingPhase 2
Nicotinamide for Retinal Protection in Primary Open-Angle Glaucoma (NADIR Trial)
Glaucoma, Open-angle, Primary Open Angle Glaucoma (POAG)
Enrolling by invitationPhase 1/2
Topical Insulin for Glaucoma (TING2)
Open Angle Glaucoma, Primary Open Angle Glaucoma

All Primary Open-Angle Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Multicenter, Randomized, Subject- and Examiner-masked, Controlled Clinical Trial Designed to Evaluate the Safety and Effectiveness of the Bimatoprost Ocular Insert as Compared to Topical Timolol Solution (0.5%) in Patients With Glaucoma or Ocular Hypertension.
ClinicalTrials.gov ID: NCT01915940
Acronym / sponsor ID: FSV5-002
Conditions: Primary Open-Angle Glaucoma, Ocular Hypertension
Keywords: Glaucoma, Primary Open-Angle Glaucoma, Ocular Hypertension
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 169 participants (actual)
Lead sponsor: ForSight Vision5, Inc.Industry (pharma, biotech, devices)
Study start: 23 Oct 2013 (actual)
Primary completion: 30 Sep 2014 (actual)
Study completion: 14 Nov 2014 (actual)
First posted: 5 Aug 2013 (estimated)
Results: Posted 20 Apr 2018

Clinical summary

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

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
13 mg Bimatoprost Ocular Insert	Experimental	Drug: Bimatoprost, Drug: Placebo Eye Drops, Device: Placebo Ocular InsertWashout 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.
Timolol 0.5% + Placebo Ocular Insert	Active comparator	Drug: Timolol 0.5%, Device: Placebo Ocular InsertWashout 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (8 listed)

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

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
BimatoprostBimatoprost ocular insert	Drug	13 mg Bimatoprost Ocular Insert
Timolol 0.5%Also: timopticTimolol 0.5% solution	Drug	Timolol 0.5% + Placebo Ocular Insert
Placebo Eye DropsPlacebo topical eye drops	Drug	13 mg Bimatoprost Ocular Insert
Placebo Ocular InsertAlso: non-medicated (placebo) Ocular InsertOcular insert without any active drug	Device	13 mg Bimatoprost Ocular Insert, Timolol 0.5% + Placebo Ocular Insert

Primary outcome

Change From Baseline in Intra-Ocular Pressure (IOP) at Week 2
Time frame: Baseline (Day 0) to 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.
Change From Baseline in Intra-Ocular Pressure (IOP) at Week 6
Time frame: Baseline (Day 0) to 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.
Change From Baseline in Intra-Ocular Pressure (IOP) at Week 12
Time frame: Baseline (Day 0) to 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.

3 secondary outcomes

Change From Baseline in IOP at Month 4
Time frame: Baseline (Day 1) to Month 4
Change From Baseline in IOP at Month 5
Time frame: Baseline (Day 0) to Month 5
Change From Baseline in IOP at Month 6
Time frame: Baseline (Day 0) to Month 6

Results and safety

Results posted to the registry on 20 Apr 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
Washout + Placebo Ocular Insert	169	130
13 mg Bimatoprost Ocular Insert	0	0
Timolol 0.5% + Placebo Ocular Insert	0	0

Primary outcome: Change From Baseline in Intra-Ocular Pressure (IOP) at Week 2

Time frame: Baseline (Day 0) to Week 2. Mean (Standard Error). Unit: mm Hg

Measure	13 mg Bimatoprost Ocular Insert n = 63	Timolol 0.5% + Placebo Ocular Insert n = 64
Baseline (T=0 hour)	24.99 (0.29)	25.34 (0.29)
Baseline (T=2 hour)	23.65 (0.31)	23.75 (0.28)
Baseline (T=8 hour)	22.95 (0.29)	23.16 (0.29)
Change from Baseline to Week 2 (T=0 hour)	-6.40 (0.41)	-6.30 (0.41)
Change from Baseline to Week 2 (T=2 hour)	-5.20 (0.34)	-5.59 (0.41)
Change from Baseline to Week 2 (T=8 hour)	-4.21 (0.35)	-4.96 (0.37)

Population analysed: Participants from the Full Analysis Set (FAS), all randomized participants who had ocular inserts placed in their eye and who had at least 1 on-treatment study visit completed, with data available for analysis at the given time-point.

Primary outcome: Change From Baseline in Intra-Ocular Pressure (IOP) at Week 6

Time frame: Baseline (Day 0) to Week 6. Mean (Standard Error). Unit: mm Hg

Measure	13 mg Bimatoprost Ocular Insert n = 63	Timolol 0.5% + Placebo Ocular Insert n = 64
Baseline (T=0 hour)	24.99 (0.29)	25.34 (0.29)
Baseline (T=2 hour)	23.65 (0.31)	23.75 (0.28)
Baseline (T=8 hour)	22.95 (0.29)	23.16 (0.29)
Change from Baseline to Week 6 (T=0 hour)	-5.47 (0.40)	-6.41 (0.41)
Change from Baseline to Week 6 (T=2 hour)	-4.70 (0.31)	-5.40 (0.39)
Change from Baseline to Week 6 (T=8 hour)	-3.78 (0.34)	-4.42 (0.39)

Primary outcome: Change From Baseline in Intra-Ocular Pressure (IOP) at Week 12

Time frame: Baseline (Day 0) to Week 12. Mean (Standard Error). Unit: mm Hg

Measure	13 mg Bimatoprost Ocular Insert n = 63	Timolol 0.5% + Placebo Ocular Insert n = 64
Baseline (T=0 hour)	24.99 (0.29)	25.34 (0.29)
Baseline (T=2 hour)	23.65 (0.31)	23.75 (0.28)
Baseline (T=8 hour)	22.95 (0.29)	23.16 (0.29)
Change from Baseline to Week 12 (T=0 hour)	-5.26 (0.47)	-6.31 (0.43)
Change from Baseline to Week 12 (T=2 hour)	-4.26 (0.44)	-5.60 (0.43)
Change from Baseline to Week 12 (T=8 hour)	-3.99 (0.33)	-5.19 (0.35)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Randomization (Day 0) to the end of study (Up to 6 Months). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
13 mg Bimatoprost Ocular Insert	1 of 64 (1.6%)	20 of 64 (31.3%)	Not reported
Timolol 0.5% + Placebo Ocular Insert	2 of 66 (3%)	14 of 66 (21.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35076329Belamkar 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.
Individual participant dataSharing planned: No

Related trials for Primary Open-Angle Glaucoma

Active, not recruiting
OMNI 3.1 Surgical System in Subjects With Primary Open-Angle Glaucoma
Primary Open Angle Glaucoma
Not yet recruiting
Evaluation the Safety and Effectiveness of the GORE GDI in Adult Subjects With Primary Open-angle Glaucoma in Whom Previous Medical and Surgical Treatment Have Failed.
Glaucoma, Primary Open Angle
Not yet recruitingPhase 4
The Effect of Lumify™ on Ocular Redness, Intraocular Pressure, and Eyelid Position in Glaucoma Patients
Glaucoma, Glaucoma, Open-Angle
Not yet recruitingPhase 2
Nicotinamide for Retinal Protection in Primary Open-Angle Glaucoma (NADIR Trial)
Glaucoma, Open-angle, Primary Open Angle Glaucoma (POAG)
Enrolling by invitationPhase 1/2
Topical Insulin for Glaucoma (TING2)
Open Angle Glaucoma, Primary Open Angle Glaucoma

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.

Michelle Chen, PhD study director

Allergan

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bimatoprost and Timolol 0.5% in people with Primary Open-Angle Glaucoma and Ocular Hypertension, run by ForSight Vision5, Inc. at 10 sites in United States.

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 5 inclusion and 8 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 20 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 20 Apr 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?

Change From Baseline in Intra-Ocular Pressure (IOP) at Week 2 (time frame: Baseline (Day 0) to Week 2). The study lists 3 primary outcomes in all. 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 NCT01915940, which also lists 1 linked publication.

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 20 Apr 2018.