GlaucomaPhase 3NCT02105285

Efficacy and Safety Study of OPC-1085EL Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension

A Phase 3 study testing OPC-1085EL ophthalmic solution and Carteolol long-acting ophthalmic solution in people with Glaucoma and Ocular Hypertension, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.

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 the efficacy and safety of OPC-1085EL ophthalmic solution in comparison with carteolol long-acting ophthalmic solution in subjects who are insufficiently responsive to carteolol long-acting ophthalmic solution. Read more about this study

Who is it for?: Ages 20 to 80 years
Conditions the study is for: Glaucoma, Ocular Hypertension
What is being tested?: OPC-1085EL ophthalmic solution and Carteolol long-acting ophthalmic solution
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 193 participants
Where: 1 siteJapan
Study dates: Apr 2014to Jan 2015
Phase: Phase 3
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 20 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects with diagnosis of bilateral primary open-angle glaucoma or ocular hypertension

Who cannot join

Subjects with ocular conditions as defined by the protocol

Trial locations and contacts

1 site in 1 country.

Japan1 site

Study site
Kansai Region

Other trials in Japan

About this study

Conditions: Glaucoma, Ocular Hypertension
Being tested: OPC-1085EL ophthalmic solution, Carteolol long-acting ophthalmic solution
Medical subject headings: Glaucoma, Ocular Hypertension

What participants receive

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

OPC-1085EL ophthalmic solutionDrug
Carteolol long-acting ophthalmic solutionDrug

Study groups in NCT02105285
Study group	Role	What they receive
OPC-1085EL ophthalmic solution	Experimental	Once daily Receives: Drug: OPC-1085EL ophthalmic solution
Carteolol long-acting ophthalmic solution	Active comparator	Once daily Receives: Drug: Carteolol long-acting ophthalmic solution

What is being measured

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

Decrease From Baseline in Intraocular Pressure at Week 8 Predose
Comparison of each group in change from baseline in intraocular pressure. Arm of "a treatment group coming together with latanoprost / carteolol" is a reference group． As for "Primary Outcome" and "Secondary Outcome" analysis , the OPC-1085EL group was compared only to the carteolol group, not to the latanoprost/carteolol concomitant group.
Measured: Baseline, Week 8 Predose

Secondary outcomes (5)

Intraocular Pressure at Week 8 Predose
Comparison of each group in intraocular pressure at Week 8 Predose. Arm of "a treatment group coming together with latanoprost / carteolol" is a reference group． As for "Primary Outcome" and "Secondary Outcome" analysis , the OPC-1085EL group was compared only to the carteolol group, not to the latanoprost/carteolol concomitant group.
The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome.
Measured: Week 8 Predose
Intraocular Pressure at Week 8 at 2 Hours After IMP Administration
Comparison of each group in intraocular pressure at Week 8 at 2 hours after IMP administration.
Arm of "a treatment group coming together with latanoprost / carteolol" is a reference group． As for "Primary Outcome" and "Secondary Outcome" analysis , the OPC-1085EL group was compared only to the carteolol group, not to the latanoprost/carteolol concomitant group.
The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome.
Measured: Week 8 at 2 hours after IMP administration
Intraocular Pressure at Week 8 at 8 Hours After IMP Administration
Comparison of each group in intraocular pressure at Week 8 at 8 hours after IMP administration.
Arm of "a treatment group coming together with latanoprost / carteolol" is a reference group． As for "Primary Outcome" and "Secondary Outcome" analysis , the OPC-1085EL group was compared only to the carteolol group, not to the latanoprost/carteolol concomitant group.
The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome.
Measured: Week 8 at 8 hours after IMP administration
Decrease From Baseline in Intraocular Pressure at Week 8 at 2 Hours After IMP Administration
Comparison of each group in change from baseline in intraocular pressure at Week 8 at 2 hours after IMP administration.
Arm of "a treatment group coming together with latanoprost / carteolol" is a reference group． As for "Primary Outcome" and "Secondary Outcome" analysis , the OPC-1085EL group was compared only to the carteolol group, not to the latanoprost/carteolol concomitant group.
The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome.
Measured: Baseline, Week 8 at 2 hours after IMP administration
Change From Baseline in Intraocular Pressure at Week 8 at 8 Hours After IMP Administration
Comparison of each group in change from baseline in intraocular pressure at Week 8 at 8 hours after IMP administration.
Arm of "a treatment group coming together with latanoprost / carteolol" is a reference group． As for "Primary Outcome" and "Secondary Outcome" analysis , the OPC-1085EL group was compared only to the carteolol group, not to the latanoprost/carteolol concomitant group.
The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome.
Measured: Baseline, Week 8 at 8 hours after IMP administration

Timeline

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

Apr 2014Jan 2015

First posted7 Apr 2014 (estimated)
Study startApr 2014
Primary completionJan 2015
Study completionJan 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 GlaucomaStudies of the same condition, open and under way.
More trials run by Otsuka Pharmaceutical Co., Ltd.The sponsor's other registered studies.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 193 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02105285
Sponsor's protocol ID: 1085EL-13-003
Status last verified: Nov 2015
First submitted: 27 Mar 2014
Last updated: 28 Dec 2015
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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All Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety Study of OPC-1085EL Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension
ClinicalTrials.gov ID: NCT02105285
Acronym / sponsor ID: 1085EL-13-003
Conditions: Glaucoma, Ocular Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 193 participants (actual)
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: Apr 2014
Primary completion: Jan 2015 (actual)
Study completion: Jan 2015 (actual)
First posted: 7 Apr 2014 (estimated)
Results: Posted 17 Nov 2015

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: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
OPC-1085EL ophthalmic solution	Experimental	Drug: OPC-1085EL ophthalmic solutionOnce daily
Carteolol long-acting ophthalmic solution	Active comparator	Drug: Carteolol long-acting ophthalmic solutionOnce daily

Who may qualify

Ages: 20 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Subjects with diagnosis of bilateral primary open-angle glaucoma or ocular hypertension

Key exclusion criteria (1 listed)

Subjects with ocular conditions as defined by the protocol

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
OPC-1085EL ophthalmic solution	Drug	OPC-1085EL ophthalmic solution
Carteolol long-acting ophthalmic solution	Drug	Carteolol long-acting ophthalmic solution

Primary outcome

Decrease From Baseline in Intraocular Pressure at Week 8 Predose
Time frame: Baseline, Week 8 Predose
Comparison of each group in change from baseline in intraocular pressure. Arm of "a treatment group coming together with latanoprost / carteolol" is a reference group． As for "Primary Outcome" and "Secondary Outcome" analysis , the OPC-1085EL group was compared only to the carteolol group, not to the latanoprost/carteolol concomitant group.

5 secondary outcomes

Intraocular Pressure at Week 8 Predose
Time frame: Week 8 Predose
Intraocular Pressure at Week 8 at 2 Hours After IMP Administration
Time frame: Week 8 at 2 hours after IMP administration
Intraocular Pressure at Week 8 at 8 Hours After IMP Administration
Time frame: Week 8 at 8 hours after IMP administration
Decrease From Baseline in Intraocular Pressure at Week 8 at 2 Hours After IMP Administration
Time frame: Baseline, Week 8 at 2 hours after IMP administration
Change From Baseline in Intraocular Pressure at Week 8 at 8 Hours After IMP Administration
Time frame: Baseline, Week 8 at 8 hours after IMP administration

Results and safety

Results posted to the registry on 17 Nov 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
OPC-1085EL Ophthalmic Solution	78	76
Carteolol Long-acting Ophthalmic Solution	78	76
Carteolol and Latanoprost Ophthalmic Solution	37	37

Primary outcome: Decrease From Baseline in Intraocular Pressure at Week 8 Predose

Time frame: Baseline, Week 8 Predose. Mean (95% Confidence Interval). Unit: mmHg

Measure	OPC-1085EL Ophthalmic Solution n = 78	Carteolol Long-acting Ophthalmic Solution n = 77
Value	3.5 (3.1 to 3.9)	1.6 (1.2 to 2.0)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the start date of IMP administration to date of the final examination (up to Week 8 at e hours after IMP administration). Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OPC-1085EL Ophthalmic Solution	0 of 78 (0%)	21 of 78 (26.9%)	Not reported
Carteolol Long-acting Ophthalmic Solution	1 of 78 (1.3%)	3 of 78 (3.8%)	Not reported
Carteolol and Latanoprost Ophthalmic Solution	0 of 37 (0%)	4 of 37 (10.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

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 1 inclusion and 1 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 28 Dec 2015. 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 Japan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 17 Nov 2015). 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?

Decrease From Baseline in Intraocular Pressure at Week 8 Predose (time frame: Baseline, Week 8 Predose). 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 NCT02105285.

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 28 Dec 2015.