Intraocular PressurePhase 2VoyagerNCT01223378

Study Comparing the Safety and Efficacy of BOL-303259-X to Latanoprost in Subjects With Glaucoma or Ocular Hypertension

A Phase 2 study testing BOL-303259-X and Latanoprost in people with Intraocular Pressure, run by Bausch & Lomb Incorporated at 1 site 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 objective of this clinical investigation is to determine the most effective drug concentration(s) of BOL-303259-X in the reduction of IOP in order to support further clinical development of an appropriate dose with regard to efficacy, and ocular and systemic safety. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Intraocular Pressure
What is being tested?: BOL-303259-X and Latanoprost
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 413 participants
Where: 1 siteUnited States
Study dates: 13 Dec 2010to 22 Jun 2012
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

Subjects must have a diagnosis of open angle glaucoma (OAG) or ocular hypertension (OH) in one or both eyes.
IOP requirements at Visit 3, A mean/median IOP ≥ 26 mmHg at a minimum of 1 time point, ≥ 24 mmHg at a minimum of 1 time point, and ≥ 22 mmHg at 1 time point in the same eye, and Mean/median IOP ≤ 32 mmHg in both eyes at all 3 measurement time points.
Subjects with best-corrected visual acuity (BCVA), using Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol, of +0.7 logMAR units (Snellen equivalent ~20/100) or better in either eye.

Who cannot join

Subjects with a known hypersensitivity or contraindications to latanoprost or any of the ingredients in the study drugs.
Subjects with known contraindications to nitric oxide (NO) treatment.
Subjects whose central corneal thickness was greater than 600um in either eye.
Subjects with any condition that prevented reliable applanation tonometry in either eye.
Subjects with advanced glaucoma and subjects with a cup/disc ratio greater than 0.8 or a history of split fixation, or a field loss threatening fixation in either eye.
Subjects with previous or active corneal disease.

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Subjects with a history of severe dry eye.
Subjects with monophthalmia.
Subjects with optic disc hemorrhage.
Subjects with a history of central retinal vein and artery occlusion.
Subjects with a history of macular edema.
Subjects with any intraocular infection, inflammation, or laser surgery within the previous 6 months from Visit 1 (Screening).
Subjects who had incisional ocular surgery or severe trauma within the previous 6 months from Visit 1 (Screening).
Subjects with very narrow angles (3 quadrants with less than Grade 2 according to Shaffer's anterior chamber angle grading system) and subjects with angle closure, congenital and secondary glaucoma, and subjects with history of angle closure in either eye.
Subjects with a diagnosis of a clinically significant or progressive retinal disease in either eye.
Subjects who were expected to require treatment with ocular or systemic corticosteroids.
Subjects who were in need of any other topical or systemic treatment of OAG or OHT.
Subjects with an anticipated need to initiate or modify medication (systemic or topical) that was known to affect IOP during the study period.

Trial locations and contacts

1 site in 1 country.

United States1 site

Bausch & Lomb, Inc
Rochester, New York, 14609

Other trials in United States

About this study

Official title: A Randomized, Multicenter, Single-Masked, Parallel-Group Dose Finding Study Comparing the Safety and Efficacy of BOL-303259-X to Latanoprost in Subjects With Open Angle Glaucoma or Ocular Hypertension

Conditions: Intraocular Pressure
Being tested: BOL-303259-X, Latanoprost

What participants receive

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

BOL-303259-XDrug
Also called latanoprostene bunod
ophthalmic solution, various concentrations, once daily (QD) 28 days
LatanoprostDrug
Also called Xalatan
0.005% ophthalmic solution, QD 28 days

Study groups in NCT01223378
Study group	Role	What they receive
BOL-303259-X	Experimental	ophthalmic solution Receives: Drug: BOL-303259-X
Latanoprost	Active comparator	ophthalmic solution Receives: Drug: Latanoprost

What is being measured

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

Change in Mean Diurnal IOP at Visit 6 (Day 28)
Determine the most effective drug concentration(s) of BOL-303259-X in the reduction of intraocular pressure (IOP) and compared to latanoprost
Measured: Baseline and Visit 6 (Day 28)

Secondary outcomes (4)

Change in Mean Diurnal IOP at Visits 4,5, and 7
Determine the most effective drug concentration(s) of BOL-303259-X in the reduction of intraocular pressure (IOP) and compared to latanoprost
Measured: Baseline and Visit 4 (Day 7), Visit 5 (day 14), and Visit 7 (Day 29)
IOP </=18mm Hg
Determine the number of subjects with mean diurnal IOP </=18 mm Hg with BOL-303259-X versus latanoprost ophthalmic solution
Measured: Visit 4 (Day 7), Visit 5 (day 14), Visit 6 (Day 28) and Visit 7 (Day 29)
Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visit 6 (Day 28)
The change in the observed mean study eye IOP from baseline (Visit 3, Day 1) at specified time points (8 AM, 12 PM, 4 PM) at Visit 6 (Day 28)
Measured: baseline and Visit 6 (Day 28)
Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)
The change in the observed mean study eye IOP from baseline (Visit 3, Day 1) at specified time points (points 8 AM, 12 PM, and 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)
Measured: baseline and Visits 4, 5 and 7 (Days 7, 14, and 29)

Timeline

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

13 Dec 201022 Jun 2012

First posted19 Oct 2010 (estimated)
Study start13 Dec 2010
Primary completion20 Dec 2011
Study completion22 Jun 2012

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 Intraocular PressureStudies 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: Screening
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 413 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01223378
Sponsor's protocol ID: 659
Acronym: Voyager
Status last verified: Jun 2018
First submitted: 11 Oct 2010
Last updated: 24 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Weinreb RN, Ong T, Scassellati Sforzolini B, Vittitow JL, Singh K, Kaufman PL; VOYAGER study group. A randomised, controlled comparison of latanoprostene bunod and latanoprost 0.005% in the treatment of ocular hypertension and open angle glaucoma: the VOYAGER study. Br J Ophthalmol. 2015 Jun;99(6):738-45. doi: 10.1136/bjophthalmol-2014-305908. Epub 2014 Dec 8.
PubMed 25488946

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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Study at a glance

From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Multicenter, Single-Masked, Parallel-Group Dose Finding Study Comparing the Safety and Efficacy of BOL-303259-X to Latanoprost in Subjects With Open Angle Glaucoma or Ocular Hypertension
ClinicalTrials.gov ID: NCT01223378
Acronym / sponsor ID: Voyager / 659
Conditions: Intraocular Pressure
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 413 participants (actual)
Lead sponsor: Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
Study start: 13 Dec 2010 (actual)
Primary completion: 20 Dec 2011 (actual)
Study completion: 22 Jun 2012 (actual)
First posted: 19 Oct 2010 (estimated)
Results: Posted 24 Jul 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: Screening
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
BOL-303259-X	Experimental	Drug: BOL-303259-Xophthalmic solution
Latanoprost	Active comparator	Drug: Latanoprostophthalmic solution

Who may qualify

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

Key inclusion criteria (3 listed)

Subjects must have a diagnosis of open angle glaucoma (OAG) or ocular hypertension (OH) in one or both eyes.
IOP requirements at Visit 3, A mean/median IOP ≥ 26 mmHg at a minimum of 1 time point, ≥ 24 mmHg at a minimum of 1 time point, and ≥ 22 mmHg at 1 time point in the same eye, and Mean/median IOP ≤ 32 mmHg in both eyes at all 3 measurement time points.
Subjects with best-corrected visual acuity (BCVA), using Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol, of +0.7 logMAR units (Snellen equivalent ~20/100) or better in either eye.

Key exclusion criteria (18 listed)

Subjects with a known hypersensitivity or contraindications to latanoprost or any of the ingredients in the study drugs.
Subjects with known contraindications to nitric oxide (NO) treatment.
Subjects whose central corneal thickness was greater than 600um in either eye.
Subjects with any condition that prevented reliable applanation tonometry in either eye.
Subjects with advanced glaucoma and subjects with a cup/disc ratio greater than 0.8 or a history of split fixation, or a field loss threatening fixation in either eye.

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
BOL-303259-XAlso: latanoprostene bunodophthalmic solution, various concentrations, once daily (QD) 28 days	Drug	BOL-303259-X
LatanoprostAlso: Xalatan0.005% ophthalmic solution, QD 28 days	Drug	Latanoprost

Primary outcome

Change in Mean Diurnal IOP at Visit 6 (Day 28)
Time frame: Baseline and Visit 6 (Day 28)
Determine the most effective drug concentration(s) of BOL-303259-X in the reduction of intraocular pressure (IOP) and compared to latanoprost

4 secondary outcomes

Change in Mean Diurnal IOP at Visits 4,5, and 7
Time frame: Baseline and Visit 4 (Day 7), Visit 5 (day 14), and Visit 7 (Day 29)
IOP </=18mm Hg
Time frame: Visit 4 (Day 7), Visit 5 (day 14), Visit 6 (Day 28) and Visit 7 (Day 29)
Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visit 6 (Day 28)
Time frame: baseline and Visit 6 (Day 28)
Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)
Time frame: baseline and Visits 4, 5 and 7 (Days 7, 14, and 29)

Results and safety

Results posted to the registry on 24 Jul 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
BOL-303259-X 0.006%	82	76
BOL-303259-X 0.012%	85	81
BOL-303259-X 0.024%	83	80
BOL-303259-X 0.040%	81	80
Latanoprost	82	79

Primary outcome: Change in Mean Diurnal IOP at Visit 6 (Day 28)

Time frame: Baseline and Visit 6 (Day 28). Mean (Standard Deviation). Unit: mm Hg

Measure	BOL-303259-X 0.006% n = 81	BOL-303259-X 0.012% n = 83	BOL-303259-X 0.024% n = 83	BOL-303259-X 0.040% n = 80	Latanoprost n = 80
Value	-7.829 (2.823)	-8.295 (2.864)	-8.952 (3.337)	-8.894 (2.666)	-7.800 (2.834)

Population analysed: Intent-to-treat population, observed data (study eye)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: The period of observation for collection of AEs extended from the time the subject gave informed consent until the last study visit (Visit 7).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BOL-303259-X 0.006%	1 of 82 (1.2%)	20 of 82 (24.4%)	0 of 82
BOL-303259-X 0.012%	0 of 84 (0%)	18 of 84 (21.4%)	0 of 84
BOL-303259-X 0.024%	0 of 83 (0%)	20 of 83 (24.1%)	0 of 83
BOL-303259-X 0.040%	0 of 81 (0%)	23 of 81 (28.4%)	0 of 81
Latanoprost	2 of 82 (2.4%)	10 of 82 (12.2%)	0 of 82

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 25488946Weinreb RN, Ong T, Scassellati Sforzolini B, Vittitow JL, Singh K, Kaufman PL; VOYAGER study group. A randomised, controlled comparison of latanoprostene bunod and latanoprost 0.005% in the treatment of ocular hypertension and open angle glaucoma: the VOYAGER study. Br J Ophthalmol. 2015 Jun;99(6):738-45. doi: 10.1136/bjophthalmol-2014-305908. Epub 2014 Dec 8.
Individual participant dataSharing planned: No

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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.

Rabia Ozden, MD study director

Bausch & Lomb Incorporated

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BOL-303259-X and Latanoprost in people with Intraocular Pressure, run by Bausch & Lomb Incorporated at 1 site 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 3 inclusion and 18 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 24 Jul 2018. 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 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 24 Jul 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 in Mean Diurnal IOP at Visit 6 (Day 28) (time frame: Baseline and Visit 6 (Day 28)). 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 NCT01223378, 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 24 Jul 2018.