Ocular HypertensionPhase 2ConstellationNCT01707381
BOL-303259-X With Timolol 0.5% in Subjects With Open-Angle Glaucoma or Ocular Hypertension
A Phase 2 study testing BOL-303259-X and Timolol maleate in people with Ocular Hypertension and Open Angle Glaucoma, run by Bausch & Lomb Incorporated at 1 site in United States.
Trial summary
This clinical investigation is being performed to compare the effect of BOL-303259-X dosed once daily (QD) with timolol maleate 0.5% dosed twice daily (BID) in reducing intraocular pressure (IOP) measured over a 24-hour period in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT). Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Ocular Hypertension, Open Angle Glaucoma
- What is being tested?
- BOL-303259-X and Timolol maleate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Feb 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must have a diagnosis of OAG or OHT in 1 or both eyes.
- Subjects who are treatment-naïve must meet the following IOP requirements at Visit 1 (Screening), and pretreated subjects must meet the following IOP requirements at Visit 2 (Washout): Intraocular pressure ≥ 22 mmHg in at least 1 eye and ≤ 36 mmHg in both eyes.
Who cannot join
- Subjects who have been exposed to BOL-303259-X within 3 months prior to Visit 1 (Screening).
- Subjects with a history or presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the results of the study.
- Subjects with an irregular daily sleep schedule.
- Subjects who are unable to wear sleep monitoring device for 7 days prior to laboratory study.
- Subjects with an anticipated need to initiate or modify medication (systemic or topical) that is known to affect IOP.
- Subjects for whom concomitant use of medications may interact with the safety or efficacy of a nitric oxide.
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- Subjects with known hypersensitivity or contraindications to latanoprost or any of the ingredients in the study drugs.
- Subjects who are expected to require treatment with ocular or systemic corticosteroids.
- Subjects who are in need of any other topical or systemic treatment of OAG or OHT.
- Subjects who are unable to discontinue contact lens use during and for 24 hours before the laboratory study.
- Subjects with a central corneal thickness greater than 600 μm in either eye.
- Subjects with any condition that prevents reliable applanationtonometry 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.
- Subjects with a history of severe dry eye.
- Subjects with active optic disc hemorrhage.
- Subjects with a history of central/branch retinal vein or artery occlusion.
- Subjects with a history of macular edema.
- Subjects with very narrow angles 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 with any intraocular infection or inflammation within 3 months prior to Visit 1 (Screening).
- Subjects with a history of ocular laser surgery within the 3 months prior to Visit 1 (Screening).
- Subjects with a history of incisional ocular surgery or severe trauma within 3 months prior to Visit 1 (Screening).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego
La Jolla, California, 92093
About this study
Official title: A Randomized, Single-Center, Open-Label, Crossover Study Comparing the Efficacy of BOL-303259-X Ophthalmic Solution With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Open-Angle Glaucoma or Ocular Hypertension.
This clinical investigation is being performed to compare the effect of BOL-303259-X dosed once daily (QD) with timolol maleate 0.5% dosed twice daily (BID) in reducing intraocular pressure (IOP) measured over a 24-hour period in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT).
- Conditions
- Ocular Hypertension, Open Angle Glaucoma
- Being tested
- BOL-303259-X, Timolol maleate
- Medical subject headings
- Ocular Hypertension, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BOL-303259-XDrug
Topical ophthalmic solution
Timolol maleateDrug
Topical ophthalmic solution
| Study group | Role | What they receive |
|---|---|---|
| Timolol Maleate | Active comparator | Timolol maleate ophthalmic solution 0.5% administered 1 drop BID once in morning and once in the evening for 4 weeks. Receives: Drug: Timolol maleate |
| BOL-303259-X | Experimental | BOL-303259-X topical ophthalmic solution administered 1 drop QD in the evening for 4 weeks. Receives: Drug: BOL-303259-X |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 Hour IOP
Supine intraocular pressure (IOP) measured in the study eye following 4 weeks of treatment
Measured: after 4 weeks of treatment
Secondary outcomes (2)
24-hour Ocular Perfusion Pressure
Sitting Ocular Perfusion Pressure = 95/140 x mean arterial blood pressure - IOP; Supine Ocular Perfusion Pressure = 115/130 x mean arterial blood pressure - IOP; the nocturnal time frame encompassed measures taken at 10pm, 12am, 2am and 4 am; whereas the diurnal time frame encompassed measures taken at 6am, 8am, 10am, 12pm, 2pm, 4pm, 6pm, and 8pm.
Measured: after 4 weeks of treatment
IOP Area Under the Curve Over 24 Hours
The Area Under the Curve(AUC) is the weighted average of IOP over all 24-hour IOP assessment times (2pm, 4pm, 6pm, 8pm, 10pm, 12am, 2am, 4am, 6am, 8am, 10am, 12pm). The AUC was calculated using the trapezoidal rule.
Measured: after 4 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2013
- Study completionFeb 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 Ocular HypertensionStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Quintus Ngumah, OD, PhD, Study director, Bausch & Lomb Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01707381
- Sponsor's protocol ID
- 803
- Acronym
- Constellation
- Status last verified
- Aug 2018
- First submitted
- 12 Oct 2012
- Last updated
- 4 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Liu JHK, Slight JR, Vittitow JL, Scassellati Sforzolini B, Weinreb RN. Efficacy of Latanoprostene Bunod 0.024% Compared With Timolol 0.5% in Lowering Intraocular Pressure Over 24 Hours. Am J Ophthalmol. 2016 Sep;169:249-257. doi: 10.1016/j.ajo.2016.04.019. Epub 2016 Jul 22.
PubMed 27457257
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-Center, Open-Label, Crossover Study Comparing the Efficacy of BOL-303259-X Ophthalmic Solution With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Open-Angle Glaucoma or Ocular Hypertension.
- ClinicalTrials.gov ID
- NCT01707381
- Acronym / sponsor ID
- Constellation / 803
- Conditions
- Ocular Hypertension, Open Angle Glaucoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 16 Oct 2012 (estimated)
- Results
- Posted 4 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical investigation is being performed to compare the effect of BOL-303259-X dosed once daily (QD) with timolol maleate 0.5% dosed twice daily (BID) in reducing intraocular pressure (IOP) measured over a 24-hour period in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Timolol Maleate | Active comparator | Drug: Timolol maleateTimolol maleate ophthalmic solution 0.5% administered 1 drop BID once in morning and once in the evening for 4 weeks. |
| BOL-303259-X | Experimental | Drug: BOL-303259-XBOL-303259-X topical ophthalmic solution administered 1 drop QD in the evening for 4 weeks. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects must have a diagnosis of OAG or OHT in 1 or both eyes.
- Subjects who are treatment-naïve must meet the following IOP requirements at Visit 1 (Screening), and pretreated subjects must meet the following IOP requirements at Visit 2 (Washout): Intraocular pressure ≥ 22 mmHg in at least 1 eye and ≤ 36 mmHg in both eyes.
Key exclusion criteria (23 listed)
- Subjects who have been exposed to BOL-303259-X within 3 months prior to Visit 1 (Screening).
- Subjects with a history or presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the results of the study.
- Subjects with an irregular daily sleep schedule.
- Subjects who are unable to wear sleep monitoring device for 7 days prior to laboratory study.
- Subjects with an anticipated need to initiate or modify medication (systemic or topical) that is known to affect IOP.
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-XTopical ophthalmic solution | Drug | BOL-303259-X |
| Timolol maleateTopical ophthalmic solution | Drug | Timolol Maleate |
Primary outcome
24 Hour IOP
Time frame: after 4 weeks of treatment
Supine intraocular pressure (IOP) measured in the study eye following 4 weeks of treatment
2 secondary outcomes
24-hour Ocular Perfusion Pressure
Time frame: after 4 weeks of treatment
IOP Area Under the Curve Over 24 Hours
Time frame: after 4 weeks of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27457257Liu JHK, Slight JR, Vittitow JL, Scassellati Sforzolini B, Weinreb RN. Efficacy of Latanoprostene Bunod 0.024% Compared With Timolol 0.5% in Lowering Intraocular Pressure Over 24 Hours. Am J Ophthalmol. 2016 Sep;169:249-257. doi: 10.1016/j.ajo.2016.04.019. Epub 2016 Jul 22.
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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.
Quintus Ngumah, OD, PhD 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 Timolol maleate in people with Ocular Hypertension and Open Angle Glaucoma, 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 2 inclusion and 23 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 Sep 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 4 Sep 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?
24 Hour IOP (time frame: after 4 weeks of treatment). 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 NCT01707381, 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 4 Sep 2018.