Primary Open-angle Glaucoma (POAG)Phase 1NCT03131167
Study of SHP639 Eye Drops in Adults With High Eye Pressure or Primary Open-angle Glaucoma
A Phase 1 study testing SHP639 (n=60) in people with Primary Open-angle Glaucoma (POAG) and Ocular Hypertension, run by Shire at 1 site in United States.
Trial summary
Safety and tolerability of three different concentrations (0.1%, 03%, 0.6%) of the investigational SHP639 eye drops will be evaluated in participants with high eye pressure or primary open-angle glaucoma. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Primary Open-angle Glaucoma (POAG), Ocular Hypertension
- What is being tested?
- SHP639 (n=60)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2017to 30 May 2018
- Phase
- Phase 1
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must provide written, signed and dated informed consent to participate in the study in accordance with the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6(R1) and applicable regulations, before completing any study-related procedures.
- Participants must be aged from 18 through 90 at the time of consent. This inclusion criterion will only be assessed at the screening visit.
- Participants must have ocular hypertension (OHT) or stable early primary open-angle glaucoma (POAG) in both eyes with acceptable Humphrey visual fields (HVF). Early POAG for this protocol is defined as healthy appearing anterior chamber angles (Shaffer classification system grade 3 or 4) and focal and/or generalized thinning of the optic disc rim characteristic of glaucomatous disease. An acceptable HVF must have been performed within approximately one year of screening, have a false-positive rate of 25 percent (%) maximum, false-negative rate of 25% maximum, and fixation loss rate of 33% maximum, and mean deviation of no worse than -6.00 decibels (dB).
- On Day -1, participants must have a mean IOP of greater than or equal to (>=) 24 millimeter of mercury (mmHg) at 8:00 AM and a mean IOP of >= 22 mmHg at 10:00 AM in at least 1 eye, with an IOP difference of less than (<) 4 mmHg between eyes at both of these time points. If only 1 eye meets this criterion, then it will be the designated study eye for pharmacodynamic analysis; this eye will also be used for dosing in Cohort A single-dose treatment period (SDTP).
- Participants must have a best-corrected visual acuity (BCVA) in both eyes of 65 letters on the Early Treatment Diabetic Retinopathy Study chart (Snellen equivalent approximately [∼] 20/60) or better at the screening and baseline assessments.
- Participants must be males or females who are non-pregnant and non-lactating at screening (negative serum beta-human chorionic gonadotropin [beta-hCG]); if sexually active during the study, they must agree to comply with the applicable contraceptive requirements throughout the study period and for 60 days following the last dose of investigational product.
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- Participants must have a satisfactory medical assessment with no clinically significant or relevant abnormalities as determined by medical history, physical examination, and clinical and laboratory evaluation (hematology, biochemistry, urinalysis) as assessed by the investigator.
- Participants must understand and be able, willing, and likely to fully comply with study procedures and restrictions.
- Participants must be non-smokers or have had stable use of tobacco or nicotine-containing products for a 3-month period before signing the informed consent form (ICF).
- Participants who drink alcohol must have had stable use of alcohol for a 3-month period before signing the ICF.
Who cannot join
- Participant has an anatomically narrow angle, synechiae or evidence of prior inflammation, angle closure glaucoma, normal tension glaucoma, pseudoexfoliation syndrome or pigmentary dispersion syndrome with or without glaucoma, or secondary glaucoma.
- Participant has corneal endothelial cell counts of less than 2000 cells per millimeter^2 (measured by noncontact specular microscopy) at the screening or baseline assessments.
- Participant has central corneal thickness less than 500 micrometer (mcm) or greater than 620 mcm at the screening or baseline assessments.
- Participant has IOP greater than 32 mmHg in either eye before randomization.
- Participant has used topical ocular hypotensive medications as follows: prostaglandin analogs, beta-adrenoceptor antagonists, alpha-adrenergic agonists, or epinephrine-related medications within 4 weeks before the first dose of investigational product; or pilocarpine or carbonic anhydrase inhibitors within 7 days before the first dose of investigational product.
- Participant has a history of angle closure, ocular surgery, microinvasive glaucoma surgery device insertion, or laser surgery, except for the following procedures, which are allowed: uncomplicated cataract surgery, laser peripheral iridotomy with resultant angle of Shaffer grade 3 or 4, and postcataract neodymium-doped yttrium-aluminum-garnet (Nd:YAG) laser posterior capsulotomy. Cataract surgery and other procedures must have occurred a minimum of 3 months before randomization.
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- Participant has a history of significant ocular trauma or ocular disease including but not limited to moderate to severe dry eye disease that requires chronic treatment or punctal plugs.
- Participant has evidence of ocular infection, inflammation, degeneration, or dystrophy at the screening or baseline assessments, including but not limited to moderate to severe blepharitis (mild blepharitis is allowed), conjunctivitis (allergic or infectious), corneal dystrophy (epithelial, stromal, or endothelial), corneal haze of grade 1 or greater based on the Hwang Grading Scale of Corneal Haze, corneal opacities, keratitis, uveitis, or vitritis.
- Participant has retinal disease including but not limited to: moderate or severe non-proliferative diabetic retinopathy (NPDR) (early NPDR is allowed), proliferative diabetic retinopathy, intermediate or advanced dry age-related macular degeneration (AMD) (early dry AMD is allowed), all geographic atrophy, or all wet AMD.
- Participant has any non-glaucomatous optic neuropathy or other significant non-glaucomatous ocular disease that is likely to affect visual function.
- Participant has any corneal or ocular surface pathology in either eye that prevents proper IOP measurement, pachymetry, or other study data collection procedures.
- Participant has had changes to their existing prescription medication regimen for chronic disease, including those medicines that affect IOP, within 14 days or 5 half-lives before screening, whichever is longer.
- Participant has started any new prescription drug medication for chronic disease, including those medicines that affect IOP, within 14 days or 5 half-lives before screening, whichever is longer.
- Participant has a history of corticosteroid use within 3 months before randomization, except for non-periocular dermatologic use, which is allowed.
- Participant has used belladonna alkaloids (scopolamine, hyoscamine, atropine) within 7 days prior to randomization, cannabinoids or opioids within 28 days before randomization, or B-type natriuretic peptides within the past year before randomization; or a participant has an anticipated need for any of the aforementioned drugs/drug categories during the study.
- Participant has used amantadine within 28 days before randomization.
- Participant is unable to discontinue contact lens use during and for 60 minutes following instillation of study medication, during ophthalmologic examinations, and during study visits.
- Participant has a current or relevant history of any physical, medical, mental, or psychiatric illness, disorder, or condition that may require treatment during the study and/or that may interfere with the participant complying with the study rules and procedures or completing the study.
- Participant has any condition that presents undue risk from use of the investigational product, assessment tools, or procedures.
- Participant is a woman who is pregnant (positive serum beta-hCG pregnancy test at the time of screening), lactating, or less than 90 days post-partum at randomization.
- Participant has donated blood within 60 days before first dose of investigational product.
- Participant has donated plasma within 28 days before first dose of investigational product.
- Participant has used another investigational product within 30 days before the first dose of investigational product or is actively enrolled in a drug or vaccine clinical study.
- Participant has a positive human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies screen.
- Participant has a positive drugs of abuse screen or alcohol breathalyzer test.
- Participant has been previously enrolled in this study.
- Participant has known hypersensitivity or allergy to any of the ingredients of the investigational product.
- Participant consumes more than 21 units of alcohol per week or is unable to refrain from alcohol consumption within 48 hours before a scheduled visit. (1 alcohol unit=1 beer or 1 wine [5 ounce per 150 milliliter] or 1 liquor [1.5 ounce per 40 milliliter] or 0.75 ounce alcohol.)
- Participant is unable to refrain from tobacco or any products containing nicotine within 8 hours before a scheduled visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-masked, Placebo-controlled Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Daily and Multiple Daily Ascending Doses of SHP639 Topical Ophthalmic Solution in Subjects With Ocular Hypertension or Primary Open-angle Glaucoma (POAG)
Safety and tolerability of three different concentrations (0.1%, 03%, 0.6%) of the investigational SHP639 eye drops will be evaluated in participants with high eye pressure or primary open-angle glaucoma.
- Being tested
- SHP639 (n=60), Placebo Comparator (n=24)
- 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.
SHP639 (n=60)Drug
Drug SHP639 is a 9-amino acid, synthetic, C-type natriuretic peptide (CNP) analog.
Placebo Comparator (n=24)Drug
Drug: Vehicle Ophthalmic placebo solution of the same composition as the test product.
| Study group | Role | What they receive |
|---|---|---|
| SHP639 Ophthalmic Solution Arm (n=60) | Experimental | Participants are divided into groups called cohorts. There will be approximately 12 cohorts, each consisting of 7 participants. In each cohort 5 out of 7 participants will be assigned a specified concentration of SHP639 (0.1%, 0.3%, or 0.6%) ophthalmic solution and a specific dosing schedule (the study participants will be instructed to insill the study drug one, two, three, or four times a day) in both eyes during the study. Receives: Drug: SHP639 (n=60) |
| Vehicle Ophthalmic Arm (n=24) | Placebo comparator | In each cohort 2 out of 7 participants will be assigned a placebo ophthalmic solution matched to 0.1%, 0.3%, and 0.6% SHP639 ophthalmic solution and specific dosing schedule (the study participants will be instructed to instill the study drug one, two, three, or four times a day) in both eyes during the study. Receives: Drug: Placebo Comparator (n=24) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Event (TEAE)
An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs were defined as AEs with a start date on or after the first dose of double-blind investigational product or a start date before the date of the first dose of double-blind investigational product that increased in severity or after the date of the first dose.
Measured: From start of study drug administration up to follow-up (Day 88)
Secondary outcomes (1)
Change From Baseline in Intra Ocular Pressure (IOP) at Day 29
IOP was measured using Goldmann applanation tonometry and reported data from baseline at day 29 for both study eye and non study eye.
Measured: Baseline, Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start10 May 2017
- Primary completion30 May 2018
- Study completion30 May 2018
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 Glaucoma (POAG)Studies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03131167
- Sponsor's protocol ID
- SHP639-101
- Status last verified
- May 2021
- First submitted
- 20 Apr 2017
- Last updated
- 8 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-masked, Placebo-controlled Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Daily and Multiple Daily Ascending Doses of SHP639 Topical Ophthalmic Solution in Subjects With Ocular Hypertension or Primary Open-angle Glaucoma (POAG)
- ClinicalTrials.gov ID
- NCT03131167
- Acronym / sponsor ID
- SHP639-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 10 May 2017 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 27 Apr 2017 (actual)
- Results
- Posted 7 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety and tolerability of three different concentrations (0.1%, 03%, 0.6%) of the investigational SHP639 eye drops will be evaluated in participants with high eye pressure or primary open-angle glaucoma.
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 |
|---|---|---|
| SHP639 Ophthalmic Solution Arm (n=60) | Experimental | Drug: SHP639 (n=60)Participants are divided into groups called cohorts. There will be approximately 12 cohorts, each consisting of 7 participants. In each cohort 5 out of 7 participants will be assigned a specified concentration of SHP639 (0.1%, 0.3%, or 0.6%) ophthalmic solution and a specific dosing schedule (the study participants will be instructed to insill the study drug one, two, three, or four times a day) in both eyes during the study. |
| Vehicle Ophthalmic Arm (n=24) | Placebo comparator | Drug: Placebo Comparator (n=24)In each cohort 2 out of 7 participants will be assigned a placebo ophthalmic solution matched to 0.1%, 0.3%, and 0.6% SHP639 ophthalmic solution and specific dosing schedule (the study participants will be instructed to instill the study drug one, two, three, or four times a day) in both eyes during the study. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participants must provide written, signed and dated informed consent to participate in the study in accordance with the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6(R1) and applicable regulations, before completing any study-related procedures.
- Participants must be aged from 18 through 90 at the time of consent. This inclusion criterion will only be assessed at the screening visit.
- Participants must have ocular hypertension (OHT) or stable early primary open-angle glaucoma (POAG) in both eyes with acceptable Humphrey visual fields (HVF). Early POAG for this protocol is defined as healthy appearing anterior chamber angles (Shaffer classification system grade 3 or 4) and focal and/or generalized thinning of the optic disc rim characteristic of glaucomatous disease. An acceptable HVF must have been performed within approximately one year of screening, have a false-positive rate of 25 percent (%) maximum, false-negative rate of 25% maximum, and fixation loss rate of 33% maximum, and mean deviation of no worse than -6.00 decibels (dB).
- On Day -1, participants must have a mean IOP of greater than or equal to (>=) 24 millimeter of mercury (mmHg) at 8:00 AM and a mean IOP of >= 22 mmHg at 10:00 AM in at least 1 eye, with an IOP difference of less than (<) 4 mmHg between eyes at both of these time points. If only 1 eye meets this criterion, then it will be the designated study eye for pharmacodynamic analysis; this eye will also be used for dosing in Cohort A single-dose treatment period (SDTP).
- Participants must have a best-corrected visual acuity (BCVA) in both eyes of 65 letters on the Early Treatment Diabetic Retinopathy Study chart (Snellen equivalent approximately [∼] 20/60) or better at the screening and baseline assessments.
Key exclusion criteria (29 listed)
- Participant has an anatomically narrow angle, synechiae or evidence of prior inflammation, angle closure glaucoma, normal tension glaucoma, pseudoexfoliation syndrome or pigmentary dispersion syndrome with or without glaucoma, or secondary glaucoma.
- Participant has corneal endothelial cell counts of less than 2000 cells per millimeter^2 (measured by noncontact specular microscopy) at the screening or baseline assessments.
- Participant has central corneal thickness less than 500 micrometer (mcm) or greater than 620 mcm at the screening or baseline assessments.
- Participant has IOP greater than 32 mmHg in either eye before randomization.
- Participant has used topical ocular hypotensive medications as follows: prostaglandin analogs, beta-adrenoceptor antagonists, alpha-adrenergic agonists, or epinephrine-related medications within 4 weeks before the first dose of investigational product; or pilocarpine or carbonic anhydrase inhibitors within 7 days before the first dose of investigational product.
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 |
|---|---|---|
| SHP639 (n=60)Drug SHP639 is a 9-amino acid, synthetic, C-type natriuretic peptide (CNP) analog. | Drug | SHP639 Ophthalmic Solution Arm (n=60) |
| Placebo Comparator (n=24)Drug: Vehicle Ophthalmic placebo solution of the same composition as the test product. | Drug | Vehicle Ophthalmic Arm (n=24) |
Primary outcome
Number of Participants With Treatment Emergent Adverse Event (TEAE)
Time frame: From start of study drug administration up to follow-up (Day 88)
An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs were defined as AEs with a start date on or after the first dose of double-blind investigational product or a start date before the date of the first dose of double-blind investigational product that increased in severity or after the date of the first dose.
1 secondary outcome
Change From Baseline in Intra Ocular Pressure (IOP) at Day 29
Time frame: Baseline, Day 29
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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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.
Study Director study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHP639 (n=60) in people with Primary Open-angle Glaucoma (POAG) and Ocular Hypertension, run by Shire 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 10 inclusion and 29 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 8 Jun 2021. 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. Some participants in this study may receive a placebo. 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 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.
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 7 Aug 2019). 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?
Number of Participants With Treatment Emergent Adverse Event (TEAE) (time frame: From start of study drug administration up to follow-up (Day 88)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jun 2021.