Open-Angle GlaucomaPhase 1/2NCT02742649

A Study to Evaluate Efficacy and Safety of a Fixed Combination Ocular Insert in Participants With Open-angle Glaucoma or Ocular Hypertension

A Phase 1/2 study testing Fixed Combination, Bimatoprost and Timolol in people with Open-Angle Glaucoma and Ocular Hypertension, run by ForSight Vision5, Inc. at 1 site in Panama.

Completed

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

Official record

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Trial summary

The purpose of this study is to determine if a combination of two drugs (bimatoprost and timolol) delivered to the surface of the eye over 10 weeks is better at lowering intraocular pressure (IOP) than either of the drugs delivered alone. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Open-Angle Glaucoma, Ocular Hypertension
What is being tested?: Fixed Combination, Bimatoprost and Timolol
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 55 participants
Where: 1 sitePanama
Study dates: 30 Apr 2016to 31 Dec 2016
Phase: Phase 1/2
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
At least 18 years of age
Diagnosis in both eyes of either primary open-angle glaucoma (POAG) or ocular hypertension
Best corrected-distance visual acuity score equivalent to 20/80 or better
Stable visual field
Central corneal thickness between 490 - 620 micrometers

Show all 9Show fewer

IOP for each eye is ≥ 23 mmHg at T=0hr, ≥ 20 mmHg at T=4hr and T=8hr.
Inter-eye IOP difference of ≤ 5.0 mmHg at T=0hr, T=4hr and T=8hr.
IOP for each eye is ≤ 30 mmHg at T=0hr, T=4hr and T=8hr.

Who cannot join

Any known contraindication to prostaglandin analog (latanoprost, travoprost, bimatoprost, tafluprost) or timolol
A cardiac or pulmonary condition that in the opinion of the Investigator would contraindicate the use of a topical beta-blocker
Use of any agents known to have a substantial effect on IOP during planned study period (e.g. beta-blockers)
Cup-to-disc ratio of 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
Ocular, orbital, and/or eyelid surgery of any type within the past six (6) months from screening date

Show all 15Show fewer

Laser surgery for glaucoma / ocular hypertension on one (1) or both eyes within the last six (6) months
Past history of any incisional surgery for glaucoma at any time
Past history of corneal refractive surgery
Corneal abnormalities that would interfere with accurate IOP readings with an applanation tonometer
Current participation in an investigational drug or device study or participation in such a study within 7 days of Screening
Inability to adequately evaluate the retina
Subjects who will require contact lens use during the study period.
Subjects who currently have punctal occlusion
Pregnant, lactating or of child-bearing potential and not using a medically acceptable form of birth control

Trial locations and contacts

1 site in 1 country.

Panama1 site

Clinica de Ojos Orillac - Calvo
Panama City

Other trials in Panama

About this study

Official title: A Phase 1B, Multicenter, Randomized, Double-masked, Controlled Study to Evaluate the Efficacy and Safety of a Fixed Combination Bimatoprost/Timolol Ocular Insert Compared to Its Individual Components With Crossover to Timolol 0.5% in Subjects With Open-angle Glaucoma (OAG) or Ocular Hypertension (OHT)

Conditions: Open-Angle Glaucoma, Ocular Hypertension
Being tested: Fixed Combination, Bimatoprost, Timolol, Placebo Segment, Timolol 0.5%
Medical subject headings: Glaucoma, Open-Angle, Ocular Hypertension

What participants receive

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

Fixed CombinationDrug
Also called Bimatoprost-Timolol combination
Continuous elution from the ocular insert.
BimatoprostDrug
Also called Bimatoprost component only
Continuous elution from the ocular insert. This is an active control arm.
TimololDrug
Also called Timolol component only
Continuous elution from the ocular insert. This is an active control arm.
Placebo SegmentDevice
One segment of placebo (no drug product)
Timolol 0.5%Drug
0.5% timolol drops twice daily.

Study groups in NCT02742649
Study group	Role	What they receive
Fixed Combination (FC) Ocular Insert	Experimental	Washout plus Placebo Ocular Insert in each eye for 24 to 48 days, followed by one segment of bimatoprost and one segment of timolol maleate combined onto a single ocular insert in each eye for 70 days. Following a second washout period, 0.5% timolol drops twice daily in each eye from Day 99 to 112. Receives: Drug: Fixed Combination; Device: Placebo Segment; Drug: Timolol 0.5%
Bimatoprost Ocular Insert	Experimental	Washout plus Placebo Ocular Insert in each eye for 24 to 48 days, followed by one segment of bimatoprost and one placebo segment (no drug product) combined onto a single ocular insert in each eye for 70 days. Following a second washout period, 0.5% timolol drops twice daily in each eye from Day 99 to 112. Receives: Drug: Bimatoprost; Device: Placebo Segment; Drug: Timolol 0.5%
Timolol Ocular Insert	Experimental	Washout plus Placebo Ocular Insert in each eye for 24 to 48 days, followed by one segment of timolol and one placebo segment (no drug product) combined onto a single ocular insert in each eye for 70 days. Following a second washout period, 0.5% timolol drops twice daily in each eye from Day 99 to 112. Receives: Drug: Timolol; Device: Placebo Segment; Drug: Timolol 0.5%

What is being measured

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

Intraocular Pressure (IOP) on Day 8
IOP is a measurement of the fluid pressure inside the eye. IOP was measured at the following three time points: 8 am (T=0 hour), 12 pm (T=4 hour) and 4 pm (T=8 hour). The IOP measured in the two eyes was averaged to compute a single IOP value for each timepoint.
Measured: Day 8
IOP on Day 16
IOP is a measurement of the fluid pressure inside the eye. IOP was measured at the following three time points: 8 am (T=0 hour), 12 pm (T=4 hour) and 4 pm (T=8 hour). The IOP measured in the two eyes was averaged to compute a single IOP value for each timepoint.
Measured: Day 16
IOP on Day 28
IOP is a measurement of the fluid pressure inside the eye. IOP was measured at the following three time points: 8 am (T=0 hour), 12 pm (T=4 hour) and 4 pm (T=8 hour). The IOP measured in the two eyes was averaged to compute a single IOP value for each timepoint.
Measured: Day 28
IOP on Day 49
IOP is a measurement of the fluid pressure inside the eye. IOP was measured at the following three time points: 8 am (T=0 hour), 12 pm (T=4 hour) and 4 pm (T=8 hour). The IOP measured in the two eyes was averaged to compute a single IOP value for each timepoint.
Measured: Day 49
IOP on Day 70
IOP is a measurement of the fluid pressure inside the eye. IOP was measured at the following three time points: 8 am (T=0 hour), 12 pm (T=4 hour) and 4 pm (T=8 hour). The IOP measured in the two eyes was averaged to compute a single IOP value for each timepoint.
Measured: Day 70

Secondary outcomes (2)

Number of Participants With Ocular and Non-Ocular Adverse Events
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. Reported here is the number of participants with adverse events related to the eye as well as number of participants with all other adverse events.
Measured: From Randomization (Day 0) to Day 70
IOP During Open Label Period
IOP is a measurement of the fluid pressure inside the eye. IOP was measured at the following three time points: 8 am (T=0 hour), 12 pm (T=4 hour) and 4 pm (T=8 hour) at the start (Day 98) and end (Day 112) of the Open Label Period during which participants were treated with timolol 0.5% ophthalmic solution twice daily. The IOP measured in the two eyes was averaged to compute a single IOP value for each timepoint.
Measured: Day 98, Day 112

Timeline

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

30 Apr 201631 Dec 2016

First posted19 Apr 2016 (estimated)
Study start30 Apr 2016
Primary completion31 Dec 2016
Study completion31 Dec 2016

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.
Other trials for 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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02742649
Sponsor's protocol ID: FSV5-FC-001
Status last verified: Feb 2019
First submitted: 6 Apr 2016
Last updated: 25 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

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A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
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Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
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All Open-Angle Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1B, Multicenter, Randomized, Double-masked, Controlled Study to Evaluate the Efficacy and Safety of a Fixed Combination Bimatoprost/Timolol Ocular Insert Compared to Its Individual Components With Crossover to Timolol 0.5% in Subjects With Open-angle Glaucoma (OAG) or Ocular Hypertension (OHT)
ClinicalTrials.gov ID: NCT02742649
Acronym / sponsor ID: FSV5-FC-001
Conditions: Open-Angle Glaucoma, Ocular Hypertension
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: ForSight Vision5, Inc.Industry (pharma, biotech, devices)
Study start: 30 Apr 2016 (actual)
Primary completion: 31 Dec 2016 (actual)
Study completion: 31 Dec 2016 (actual)
First posted: 19 Apr 2016 (estimated)
Results: Posted 31 Dec 2018

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
Fixed Combination (FC) Ocular Insert	Experimental	Drug: Fixed Combination, Device: Placebo Segment, Drug: Timolol 0.5%Washout plus Placebo Ocular Insert in each eye for 24 to 48 days, followed by one segment of bimatoprost and one segment of timolol maleate combined onto a single ocular insert in each eye for 70 days. Following a second washout period, 0.5% timolol drops twice daily in each eye from Day 99 to 112.
Bimatoprost Ocular Insert	Experimental	Drug: Bimatoprost, Device: Placebo Segment, Drug: Timolol 0.5%Washout plus Placebo Ocular Insert in each eye for 24 to 48 days, followed by one segment of bimatoprost and one placebo segment (no drug product) combined onto a single ocular insert in each eye for 70 days. Following a second washout period, 0.5% timolol drops twice daily in each eye from Day 99 to 112.
Timolol Ocular Insert	Experimental	Drug: Timolol, Device: Placebo Segment, Drug: Timolol 0.5%Washout plus Placebo Ocular Insert in each eye for 24 to 48 days, followed by one segment of timolol and one placebo segment (no drug product) combined onto a single ocular insert in each eye for 70 days. Following a second washout period, 0.5% timolol drops twice daily in each eye from Day 99 to 112.

Who may qualify

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

Key inclusion criteria (9 listed)

Written informed consent
At least 18 years of age
Diagnosis in both eyes of either primary open-angle glaucoma (POAG) or ocular hypertension
Best corrected-distance visual acuity score equivalent to 20/80 or better
Stable visual field

Key exclusion criteria (15 listed)

Any known contraindication to prostaglandin analog (latanoprost, travoprost, bimatoprost, tafluprost) or timolol
A cardiac or pulmonary condition that in the opinion of the Investigator would contraindicate the use of a topical beta-blocker
Use of any agents known to have a substantial effect on IOP during planned study period (e.g. beta-blockers)
Cup-to-disc ratio of 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

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
Fixed CombinationAlso: Bimatoprost-Timolol combinationContinuous elution from the ocular insert.	Drug	Fixed Combination (FC) Ocular Insert
BimatoprostAlso: Bimatoprost component onlyContinuous elution from the ocular insert. This is an active control arm.	Drug	Bimatoprost Ocular Insert
TimololAlso: Timolol component onlyContinuous elution from the ocular insert. This is an active control arm.	Drug	Timolol Ocular Insert
Placebo SegmentOne segment of placebo (no drug product)	Device	Bimatoprost Ocular Insert, Fixed Combination (FC) Ocular Insert, Timolol Ocular Insert
Timolol 0.5%0.5% timolol drops twice daily.	Drug	Bimatoprost Ocular Insert, Fixed Combination (FC) Ocular Insert, Timolol Ocular Insert

Primary outcome

Intraocular Pressure (IOP) on Day 8
Time frame: Day 8
IOP is a measurement of the fluid pressure inside the eye. IOP was measured at the following three time points: 8 am (T=0 hour), 12 pm (T=4 hour) and 4 pm (T=8 hour). The IOP measured in the two eyes was averaged to compute a single IOP value for each timepoint.
IOP on Day 16
Time frame: Day 16
IOP is a measurement of the fluid pressure inside the eye. IOP was measured at the following three time points: 8 am (T=0 hour), 12 pm (T=4 hour) and 4 pm (T=8 hour). The IOP measured in the two eyes was averaged to compute a single IOP value for each timepoint.
IOP on Day 28
Time frame: Day 28
IOP is a measurement of the fluid pressure inside the eye. IOP was measured at the following three time points: 8 am (T=0 hour), 12 pm (T=4 hour) and 4 pm (T=8 hour). The IOP measured in the two eyes was averaged to compute a single IOP value for each timepoint.
IOP on Day 49
Time frame: Day 49
IOP is a measurement of the fluid pressure inside the eye. IOP was measured at the following three time points: 8 am (T=0 hour), 12 pm (T=4 hour) and 4 pm (T=8 hour). The IOP measured in the two eyes was averaged to compute a single IOP value for each timepoint.
IOP on Day 70
Time frame: Day 70
IOP is a measurement of the fluid pressure inside the eye. IOP was measured at the following three time points: 8 am (T=0 hour), 12 pm (T=4 hour) and 4 pm (T=8 hour). The IOP measured in the two eyes was averaged to compute a single IOP value for each timepoint.

2 secondary outcomes

Number of Participants With Ocular and Non-Ocular Adverse Events
Time frame: From Randomization (Day 0) to Day 70
IOP During Open Label Period
Time frame: Day 98, Day 112

Results and safety

Results posted to the registry on 31 Dec 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	55	50
Fixed Combination (FC) Ocular Insert	0	0
Bimatoprost Ocular Insert	0	0
Timolol Ocular Insert	0	0
Timolol 0.5% Ophthalmic Drops	0	0

Primary outcome: Intraocular Pressure (IOP) on Day 8

Time frame: Day 8. Mean (Standard Deviation). Unit: mm Hg

Measure	Fixed Combination (FC) Ocular Insert n = 17	Bimatoprost Ocular Insert n = 17	Timolol Ocular Insert n = 16
Day 8 (T=0 hour)	17.83 (3.39)	19.15 (2.62)	19.59 (4.68)
Day 8 (T=4 hour)	17.51 (3.18)	18.96 (4.14)	19.88 (5.42)
Day 8 (T=8 hour)	17.05 (3.32)	17.84 (4.00)	19.66 (4.54)

Population analysed: FAS included all participants who were randomized, treated and returned for at least one (1) regularly scheduled post-treatment visit. Participants were analyzed in the treatment group to which they were randomized (Double Blind Treatment Period).

Primary outcome: IOP on Day 16

Time frame: Day 16. Mean (Standard Deviation). Unit: mm Hg

Measure	Fixed Combination (FC) Ocular Insert n = 15	Bimatoprost Ocular Insert n = 17	Timolol Ocular Insert n = 16
Day 16 (T=0 hour)	18.29 (3.86)	18.08 (3.98)	20.81 (5.22)
Day 16 (T=4 hour)	17.95 (3.10)	18.64 (4.17)	21.08 (5.46)
Day 16 (T=8 hour)	17.21 (4.14)	18.54 (3.73)	19.43 (3.77)

Primary outcome: IOP on Day 28

Time frame: Day 28. Mean (Standard Deviation). Unit: mm Hg

Measure	Fixed Combination (FC) Ocular Insert n = 16	Bimatoprost Ocular Insert n = 17	Timolol Ocular Insert n = 16
Day 28 (T=0 hour)	18.03 (4.21)	18.44 (4.23)	19.75 (4.80)
Day 28 (T=4 hour)	18.54 (3.50)	19.59 (3.70)	20.09 (4.67)
Day 28 (T=8 hour)	17.26 (2.60)	18.77 (4.13)	19.20 (3.60)

Primary outcome: IOP on Day 49

Time frame: Day 49. Mean (Standard Deviation). Unit: mm Hg

Measure	Fixed Combination (FC) Ocular Insert n = 15	Bimatoprost Ocular Insert n = 17	Timolol Ocular Insert n = 16
Day 49 (T=0 hour)	18.55 (4.05)	18.88 (4.52)	18.63 (3.89)
Day 49 (T=4 hour)	17.77 (4.02)	19.35 (3.51)	19.67 (3.54)
Day 49 (T=8 hour)	17.23 (4.53)	18.48 (3.57)	19.13 (2.40)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Randomization (Day 0) to the end of the study (Day 112). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fixed Combination (FC) Ocular Inset	2 of 17 (11.8%)	16 of 17 (94.1%)	0 of 17
Bimatoprost Ocular Insert	1 of 17 (5.9%)	16 of 17 (94.1%)	0 of 17
Timolol Ocular Insert	0 of 16 (0%)	11 of 16 (68.8%)	0 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Open-Angle Glaucoma

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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

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

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Fixed Combination, Bimatoprost and Timolol in people with Open-Angle Glaucoma and Ocular Hypertension, run by ForSight Vision5, Inc. at 1 site in Panama.

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 9 inclusion and 15 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 25 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Panama. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 31 Dec 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?

Intraocular Pressure (IOP) on Day 8 (time frame: Day 8). The study lists 5 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 NCT02742649.

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 25 Feb 2019.