Primary Open-Angle GlaucomaPhase 2NCT02358369

Dose-Ranging Study of the Bimatoprost Ocular Insert

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

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Trial summary

The Bimatoprost Ocular Insert is intended to provide sustained delivery of bimatoprost to the ocular surface to lower the intraocular pressure (IOP) in patients with Open-Angle Glaucoma or Ocular Hypertension. 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: 156 participants
Where: 10 sitesUnited States
Study dates: 19 Jan 2015to 7 Oct 2015
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
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 10Show fewer

("T" is defined as time and "hr" is defined as hour[s])
IOP for each eye is ≥ 23 mm Hg at T=0 hr, ≥ 20 mm Hg at T=2 hr and T=8 hr.
Inter-eye IOP difference of ≤ 5.0 mm Hg at T=0 hr, T=2 hr and T=8 hr.
IOP for each eye is ≤ 30 mm Hg at T=0 hr, T=2 hr and T=8 hr.

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 beta-blocker drops
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
Laser surgery for glaucoma / ocular hypertension on one (1) or both eyes within the last six (6) months

Show all 14Show fewer

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 30 days of Screening
Inability to adequately evaluate the retina
Participants who will require contact lens use during the study period.
Participants 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

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

Sall Medical Research Center
Artesia, California, 90701
Mundorf Eye Center
Charlotte, North Carolina, 28204
Vold Vision
Fayetteville, Arkansas, 72704
Cornerstone Health Care
High Point, North Carolina, 27262
Apex Eye
Madeira, Ohio, 45243
University of Eye Specialists
Maryville, Tennessee, 37803
Total Eye Care
Memphis, Tennessee, 38119
Clayton Eye Center
Morrow, Georgia, 30260
Eye Research Foundation
Newport Beach, California, 92663
R&R Eye Research, LLC
San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: A Phase 2 Prospective, Multicenter, Randomized, Double-masked, Controlled Study to Evaluate the Efficacy and Safety and Dose-response of the Bimatoprost Ocular Insert (2.2 mg, 13 mg) With and Without Concomitant Artificial Tears Compared to a Placebo Ocular Insert With and Without Concomitant Timolol (0.5%) Ophthalmic Solution in Patients With Open-angle Glaucoma or Ocular Hypertension

This study evaluated the safety and efficacy of two different doses of the Bimatoprost Ocular Insert, compared to an active control arm with timolol ophthalmic solution (0.5%).

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

BimatoprostDrug
Bimatoprost sustained release Ocular Insert
Timolol 0.5%Drug
BID drops OU, 0.5% ophthalmic solution
Placebo Ocular InsertDevice
Placebo ocular insert OU.
Placebo Eye DropsDrug
Placebo eye drops BID OU.

Study groups in NCT02358369
Study group	Role	What they receive
13 mg Bimatoprost Ocular Insert	Experimental	Washout + Placebo Ocular Insert in each eye for 4 to 6 weeks, followed by 13 mg Bimatoprost Ocular Insert in each eye (OU) for 12 weeks. Note: participants also self-administered placebo ophthalmic eye drops to each eye twice a day (BID) for the first 6 weeks. After 12 weeks, 13 mg Bimatoprost Ocular Insert in each eye for an additional 12 weeks. Receives: Drug: Bimatoprost; Device: Placebo Ocular Insert; Drug: Placebo Eye Drops
2.2 mg Bimatoprost Ocular Insert	Experimental	Washout + Placebo Ocular Insert in each eye for 4 to 6 weeks, followed by 2.2 mg Bimatoprost Ocular Insert in each eye for 12 weeks. Note: participants also self-administered placebo ophthalmic eye drops in each eye twice a day for the first 6 weeks. After 12 weeks, 13 mg Bimatoprost Ocular Insert in each eye for an additional 12 weeks. Receives: Drug: Bimatoprost; Device: Placebo Ocular Insert; Drug: Placebo Eye Drops
Timolol 0.5%	Active comparator	Washout + Placebo Ocular Insert in each eye for 4 to 6 weeks, followed by 0.5% timolol ophthalmic solution in each eye for 6 weeks. Note: participants simultaneously wore placebo ocular inserts for 12 weeks. After 12 weeks, 13 mg Bimatoprost Ocular Insert in each eye for an additional 12 weeks. Receives: Drug: Bimatoprost; 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 Intraocular Pressure (IOP) at Week 8
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 8. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated an improvement.
Measured: Baseline (Day 0) to Week 8
Change From Baseline in 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 an improvement.
Measured: Baseline (Day 0) to Week 12
Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
Measured: Baseline (Day 0) to Week 8
Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
Measured: Baseline (Day 0) to Week 12
Percentage of Participants With Clinically Significant Change From Baseline in Slit-Lamp Examination Findings at Week 12
The clinician examined and graded the eyelids, conjunctiva, cornea and anterior chamber of the eye with the aid of a slit-lamp, (conjunctival erythema was assessed as part of the examination). Fluorescein dye was instilled into the ocular cul-de-sac to facilitate this examination.
Measured: Baseline (Day 0) to Week 12
Change From Baseline in Automated Visual Field at Week 12
Automated Visual Field was examined used the Humphrey Visual Field Analyzer, a test that measures the entire area of peripheral vision that can be seen while the eye is focused on a central point. A positive change from Baseline indicates improvement.
Measured: Baseline (Day 0) to Week 12
Dilated Fundus Exam: Cup-to-Disc-Ratio
The cup-to-disk-ratio is an eye test to assess the progression of glaucoma. The diameter of the cup is compared to the diameter of the disk and a ratio is determined. The normal cup-disk ratio is 0.3. An increase in the cup-to-disc-ratio is a possible indication of glaucoma.
Measured: Week 12
Percentage of Participants by Dilated Fundus Exam Pathology Grade at Week 12
Dilated fundus examination pathology findings were noted, described and graded on a scale of None (0), Mild (+1), Moderate (+2) and Severe (+3). The percentage of participants in each grade is reported.
Measured: Week 12
Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period A/B
An AE was defined as any untoward medical occurrence (eg, sign, symptom, disease, syndrome, intercurrent illness) that occurred in a study participant, regardless of the suspected cause during the study. An ocular AE is an AE that occurred in the eye and non-ocular is an AE that occurred not in the eye. Th investigator assessed the worst severity of each AE as: Mild=aware of sign or symptom, but readily tolerated, Moderate=discomfort enough to cause interference with usual activity or Severe=incapacitating with inability to work or do usual activity.
Measured: Baseline (Day 0) to Week 12
Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period C
An AE was defined as any untoward medical occurrence (eg, sign, symptom, disease, syndrome, intercurrent illness) that occurred in a study participant, regardless of the suspected cause during the study. An ocular AE is an AE that occurred in the eye and non-ocular is an AE that occurred not in the eye. The investigator assessed the worst severity of each AE as: Mild=aware of sign or symptom, but readily tolerated, Moderate=discomfort enough to cause interference with usual activity or Severe=incapacitating with inability to work or do usual activity.
Measured: Week 12 to Week 24

Secondary outcomes (3)

Change From Baseline in IOP at Week 2
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 2. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated an improvement.
Measured: Baseline (Day 0) to Week 2
Change From Baseline in 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 an improvement.
Measured: Baseline (Day 0) to Week 6
Change From Baseline in IOP in Period C
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 Weeks 14, 18 and 24. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated an improvement.
Measured: Baseline (Day 0) to Weeks 14, 18 and 24

Timeline

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

19 Jan 20157 Oct 2015

First posted9 Feb 2015 (estimated)
Study start19 Jan 2015
Primary completion31 Aug 2015
Study completion7 Oct 2015

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 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 156 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02358369
Sponsor's protocol ID: FSV5-004
Status last verified: May 2020
First submitted: 21 Jan 2015
Last updated: 4 Jun 2020
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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Active, not recruitingObservational study
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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

All Primary Open-Angle Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2 Prospective, Multicenter, Randomized, Double-masked, Controlled Study to Evaluate the Efficacy and Safety and Dose-response of the Bimatoprost Ocular Insert (2.2 mg, 13 mg) With and Without Concomitant Artificial Tears Compared to a Placebo Ocular Insert With and Without Concomitant Timolol (0.5%) Ophthalmic Solution in Patients With Open-angle Glaucoma or Ocular Hypertension
ClinicalTrials.gov ID: NCT02358369
Acronym / sponsor ID: FSV5-004
Conditions: Primary Open-Angle Glaucoma, Ocular Hypertension
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 156 participants (actual)
Lead sponsor: ForSight Vision5, Inc.Industry (pharma, biotech, devices)
Study start: 19 Jan 2015 (actual)
Primary completion: 31 Aug 2015 (actual)
Study completion: 7 Oct 2015 (actual)
First posted: 9 Feb 2015 (estimated)
Results: Posted 4 Jun 2020

Clinical summary

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

This study evaluated the safety and efficacy of two different doses of the Bimatoprost Ocular Insert, compared to an active control arm with timolol ophthalmic solution (0.5%).

Study design

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

Arm	Type	Receives
13 mg Bimatoprost Ocular Insert	Experimental	Drug: Bimatoprost, Device: Placebo Ocular Insert, Drug: Placebo Eye DropsWashout + Placebo Ocular Insert in each eye for 4 to 6 weeks, followed by 13 mg Bimatoprost Ocular Insert in each eye (OU) for 12 weeks. Note: participants also self-administered placebo ophthalmic eye drops to each eye twice a day (BID) for the first 6 weeks. After 12 weeks, 13 mg Bimatoprost Ocular Insert in each eye for an additional 12 weeks.
2.2 mg Bimatoprost Ocular Insert	Experimental	Drug: Bimatoprost, Device: Placebo Ocular Insert, Drug: Placebo Eye DropsWashout + Placebo Ocular Insert in each eye for 4 to 6 weeks, followed by 2.2 mg Bimatoprost Ocular Insert in each eye for 12 weeks. Note: participants also self-administered placebo ophthalmic eye drops in each eye twice a day for the first 6 weeks. After 12 weeks, 13 mg Bimatoprost Ocular Insert in each eye for an additional 12 weeks.
Timolol 0.5%	Active comparator	Drug: Bimatoprost, Drug: Timolol 0.5%, Device: Placebo Ocular InsertWashout + Placebo Ocular Insert in each eye for 4 to 6 weeks, followed by 0.5% timolol ophthalmic solution in each eye for 6 weeks. Note: participants simultaneously wore placebo ocular inserts for 12 weeks. After 12 weeks, 13 mg Bimatoprost Ocular Insert in each eye for an additional 12 weeks.

Who may qualify

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

Key inclusion criteria (10 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 (14 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 beta-blocker drops
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

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 sustained release Ocular Insert	Drug	13 mg Bimatoprost Ocular Insert, 2.2 mg Bimatoprost Ocular Insert, Timolol 0.5%
Timolol 0.5%BID drops OU, 0.5% ophthalmic solution	Drug	Timolol 0.5%
Placebo Ocular InsertPlacebo ocular insert OU.	Device	13 mg Bimatoprost Ocular Insert, 2.2 mg Bimatoprost Ocular Insert, Timolol 0.5%
Placebo Eye DropsPlacebo eye drops BID OU.	Drug	13 mg Bimatoprost Ocular Insert, 2.2 mg Bimatoprost Ocular Insert

Primary outcome

Change From Baseline in Intraocular Pressure (IOP) at Week 8
Time frame: Baseline (Day 0) to Week 8
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 8. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated an improvement.
Change From Baseline in 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 an improvement.
Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8
Time frame: Baseline (Day 0) to Week 8
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12
Time frame: Baseline (Day 0) to Week 12
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
Percentage of Participants With Clinically Significant Change From Baseline in Slit-Lamp Examination Findings at Week 12
Time frame: Baseline (Day 0) to Week 12
The clinician examined and graded the eyelids, conjunctiva, cornea and anterior chamber of the eye with the aid of a slit-lamp, (conjunctival erythema was assessed as part of the examination). Fluorescein dye was instilled into the ocular cul-de-sac to facilitate this examination.
Change From Baseline in Automated Visual Field at Week 12
Time frame: Baseline (Day 0) to Week 12
Automated Visual Field was examined used the Humphrey Visual Field Analyzer, a test that measures the entire area of peripheral vision that can be seen while the eye is focused on a central point. A positive change from Baseline indicates improvement.
Dilated Fundus Exam: Cup-to-Disc-Ratio
Time frame: Week 12
The cup-to-disk-ratio is an eye test to assess the progression of glaucoma. The diameter of the cup is compared to the diameter of the disk and a ratio is determined. The normal cup-disk ratio is 0.3. An increase in the cup-to-disc-ratio is a possible indication of glaucoma.
Percentage of Participants by Dilated Fundus Exam Pathology Grade at Week 12
Time frame: Week 12
Dilated fundus examination pathology findings were noted, described and graded on a scale of None (0), Mild (+1), Moderate (+2) and Severe (+3). The percentage of participants in each grade is reported.
Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period A/B
Time frame: Baseline (Day 0) to Week 12
An AE was defined as any untoward medical occurrence (eg, sign, symptom, disease, syndrome, intercurrent illness) that occurred in a study participant, regardless of the suspected cause during the study. An ocular AE is an AE that occurred in the eye and non-ocular is an AE that occurred not in the eye. Th investigator assessed the worst severity of each AE as: Mild=aware of sign or symptom, but readily tolerated, Moderate=discomfort enough to cause interference with usual activity or Severe=incapacitating with inability to work or do usual activity.
Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period C
Time frame: Week 12 to Week 24
An AE was defined as any untoward medical occurrence (eg, sign, symptom, disease, syndrome, intercurrent illness) that occurred in a study participant, regardless of the suspected cause during the study. An ocular AE is an AE that occurred in the eye and non-ocular is an AE that occurred not in the eye. The investigator assessed the worst severity of each AE as: Mild=aware of sign or symptom, but readily tolerated, Moderate=discomfort enough to cause interference with usual activity or Severe=incapacitating with inability to work or do usual activity.

3 secondary outcomes

Change From Baseline in IOP at Week 2
Time frame: Baseline (Day 0) to Week 2
Change From Baseline in IOP at Week 6
Time frame: Baseline (Day 0) to Week 6
Change From Baseline in IOP in Period C
Time frame: Baseline (Day 0) to Weeks 14, 18 and 24

Results and safety

Results posted to the registry on 4 Jun 2020, 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	156	121
Placebo Ocular Insert + Timolol 0.5% (Period A/B)	0	0
2.2 mg Bimatoprost Ocular Insert (Period A/B)	0	0
13 mg Bimatoprost Ocular Insert (Period A/B)	0	0
13 mg Bimatoprost Ocular Insert (Period C)	0	0

Primary outcome: Change From Baseline in Intraocular Pressure (IOP) at Week 8

Time frame: Baseline (Day 0) to Week 8. Mean (Standard Deviation). Unit: mm Hg

Measure	Placebo Ocular Insert + Timolol 0.5% (Period A/B) n = 38	2.2 mg Bimatoprost Ocular Insert (Period A/B) n = 35	13 mg Bimatoprost Ocular Insert (Period A/B) n = 36
Change from Baseline to Week 8 (T=0 hour)	-4.68 (2.931)	-3.68 (3.105)	-4.56 (3.007)
Change from Baseline to Week 8 (T=2 hour)	-3.62 (2.924)	-3.31 (3.063)	-3.98 (3.522)
Change from Baseline to Week 8 (T=8 hour)	-3.21 (2.812)	-3.23 (2.573)	-3.22 (3.061)

Population analysed: Participants from the FAS, all participants who were randomized, treated and returned for at least one post-treatment visit, with data available at Week 8.

Primary outcome: Change From Baseline in IOP at Week 12

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

Measure	Placebo Ocular Insert + Timolol 0.5% (Period A/B) n = 38	2.2 mg Bimatoprost Ocular Insert (Period A/B) n = 35	13 mg Bimatoprost Ocular Insert (Period A/B) n = 37
Change from Baseline to Week 12 (T=0 hour)	-3.37 (3.147)	-3.64 (3.454)	-4.08 (2.893)
Change from Baseline to Week 12 (T=2 hour)	-2.74 (2.891)	-3.67 (3.182)	-3.40 (3.815)
Change from Baseline to Week 12 (T=8 hour)	-2.34 (2.756)	-3.20 (2.491)	-2.69 (2.523)

Population analysed: FAS, all participants who were randomized, treated and returned for at least one post-treatment visit, with data available at Week 12. Participants on rescue therapy with missing data during the evaluation period or measurements out of the pre-specified visit window had IOP data imputed using LOCF (last observation carried forward) for the visit.

Primary outcome: Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8

Time frame: Baseline (Day 0) to Week 8. Number. Unit: percentage of participants

Measure	Placebo Ocular Insert + Timolol 0.5% (Period A/B) n = 38	2.2 mg Bimatoprost Ocular Insert (Period A/B) n = 39	13 mg Bimatoprost Ocular Insert (Period A/B) n = 36
Right Eye, 10+ Letter Improvement	2.6	0	2.8
Right Eye, 5+ Letter Improvement	18.4	7.7	5.6
Right Eye, No Change	65.8	69.2	77.8
Right Eye, 5- Letter Worsening	13.2	17.9	13.9
Right Eye, 10- Letter Worsening	0	5.1	0
Left Eye, 10+ Letter Improvement	2.6	0	5.6
Left Eye, 5+ Letter Improvement	10.5	20.5	19.4
Left Eye, No Change	68.4	66.7	66.7

Population analysed: Participants from the Safety Population, all randomized participants who had an ocular insert placed, with data available for analysis at Week 8.

Primary outcome: Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12

Time frame: Baseline (Day 0) to Week 12. Number. Unit: percentage of participants

Measure	Placebo Ocular Insert + Timolol 0.5% (Period A/B) n = 38	2.2 mg Bimatoprost Ocular Insert (Period A/B) n = 38	13 mg Bimatoprost Ocular Insert (Period A/B) n = 36
Right Eye, 10+ Letter Improvement	0	0	2.8
Right Eye, 5+ Letter Improvement	7.9	5.3	11.1
Right Eye, No Change	73.7	57.9	61.1
Right Eye, 5- Letter Worsening	13.2	28.9	22.2
Right Eye, 10- Letter Worsening	5.3	7.9	2.8
Left Eye, 10+ Letter Improvement	0	0	5.6
Left Eye, 5+ Letter Improvement	7.9	13.2	19.4
Left Eye, No Change	71.1	68.4	61.1

Population analysed: Participants from the Safety Population, all randomized participants who had an ocular insert placed, with data available for analysis at Week 12.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Washout + Placebo Ocular Insert	0 of 156 (0%)	9 of 156 (5.8%)	Not reported
Placebo Ocular Insert + Timolol 0.5%	3 of 40 (7.5%)	16 of 40 (40%)	Not reported
2.2 mg Bimatoprost Ocular Insert	1 of 40 (2.5%)	12 of 40 (30%)	Not reported
13 mg Bimatoprost Ocular Insert	1 of 41 (2.4%)	20 of 41 (48.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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

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 10 inclusion and 14 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 4 Jun 2020. 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 4 Jun 2020). 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 Intraocular Pressure (IOP) at Week 8 (time frame: Baseline (Day 0) to Week 8). The study lists 10 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 NCT02358369.

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 4 Jun 2020.