Glaucoma, Open-anglePhase 1NCT03293992
A Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7058584 Following 7 Days of Instillation of Eye Drops in Patients With Primary Open Angle Glaucoma or Ocular Hypertension
A Phase 1 study testing 0.01% RO7058584, 0.1% RO7058584 and 1% RO7058584 in people with Glaucoma, Open-angle and Ocular Hypertension, run by Hoffmann-La Roche at 8 sites in United States.
Trial summary
This is a Phase I, multi-center, randomized, adaptive, investigator/patient-masked, placebo-controlled, parallel multiple-ascending dose study (Part A) with an extension including up to two selected doses from Part A and latanoprost 0.005% as active comparator (Part B). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Glaucoma, Open-angle, Ocular Hypertension
- What is being tested?
- 0.01% RO7058584, 0.1% RO7058584 and 1% RO7058584
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 8 sitesUnited States
- Study dates
- 10 Oct 2017to 21 Dec 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- 18 to 90 years of age inclusive, at the time of signing the informed consent form
- Confirmed diagnosis of ocular hypertension (OHT) or primary open-angle glaucoma (POAG) in both eyes as determined by the investigator at screening
- Treatment-naïve participants or participants who are able to safely stop their Intraocular pressure (IOP)-lowering medication(s) prior to randomization according to the required minimum washout periods
- At baseline visit, IOP ≥ 24 millimeters of mercury (mmHg) in the morning (8:00 AM ± 1h) and ≥ 22 mmHg in the afternoon (2:00 PM ± 1h) measurement in the same eye and ≤ 34 mmHg at all timepoints in both eyes
- Best corrected logarithm of the minimum angle of resolution (logMAR) visual acuity score of 0.7 or better in each eye as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity test at screening
- Central corneal thickness (pachymetry) measurement 450 to 620 micrometers (μm) in both eyes at screening
- Cup-to-disc ratio ≤ 0.8 (both eyes) at screening
- Anterior chamber angle is open and non-occludable (both eyes) as confirmed by the investigator by gonioscopy examination at screening
Who cannot join
- Advanced visual field defects
- Other forms of glaucoma than POAG or OHT
- Any abnormality preventing reliable applanation tonometry
- Any clinically significant corneal scarring, haze or opacity
- Uncooperativeness of the participant that restricts adequate examination of IOP, ocular fundus or anterior chamber
- Any presence or history of uveitis or other history of any ocular inflammatory disease.
Show all 15Show fewer
- History or signs of penetrating ocular trauma
- Risk of visual field or visual acuity worsening in either eye as a consequence of glaucoma progression or consequence of participation in the trial or any other ocular disease, according to the investigator's best judgment
- History of any glaucoma surgery
- History of refractive surgery
- Any other intra-ocular surgery within six months of screening
- Any active ocular disease requiring treatment.
- Use of any listed prohibited medications
- Current enrollment or past participation within the last 30 days before the screening visit in any other clinical study involving an investigational study treatment or any other type of medical research
- Any participant who is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff thereof, directly involved in the conduct of the protocol
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Sall Research Medical Center
Artesia, California, 90701
Rocky Mountain Lions Eye Inst
Aurora, Colorado, 80045
Texan Eye/Keystone Research
Austin, Texas, 78731
Arizona Eye Center
Chandler, Arizona, 85225
United Med Res Inst
Inglewood, California, 90301
Eye Care Centers Management, Inc. (Clayton Eye Center)
Morrow, Georgia, 30260
Eye research foundation
Newport Beach, California, 92663
Coastal Research Associates
Roswell, Georgia, 30076
About this study
Official title: A Phase I, Multi-Center, Randomized, Adaptive, Investigator/Patient Masked, Multiple-Ascending Dose, Placebo and Active Comparator-Controlled Parallel Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7058584 Following 7 Days of Topical Instillation of Eye Drops in Patients With Primary Open Angle Glaucoma or Ocular Hypertension
This is a Phase I, multi-center, randomized, adaptive, investigator/patient-masked, placebo-controlled, parallel multiple-ascending dose study (Part A) with an extension including up to two selected doses from Part A and latanoprost 0.005% as active comparator (Part B).
- Conditions
- Glaucoma, Open-angle, Ocular Hypertension
- Being tested
- 0.01% RO7058584, 0.1% RO7058584, 1% RO7058584, Matching Placebo, Latanoprost 0.005%
- 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.
0.01% RO7058584Drug
Once daily morning administration for 7 days
0.1% RO7058584Drug
Once daily morning administration for 7 days
1% RO7058584Drug
Once daily morning administration for 7 days
Matching PlaceboDrug
Once daily morning administration for 7 days
Latanoprost 0.005%Drug
Once daily morning or evening dosing
| Study group | Role | What they receive |
|---|---|---|
| 0.01% RO7058584 or Matching Placebo | Experimental | Not described Receives: Drug: 0.01% RO7058584; Drug: Matching Placebo |
| 0.1% RO7058584 or Matching Placebo | Experimental | Not described Receives: Drug: 0.1% RO7058584; Drug: Matching Placebo |
| 1% RO7058584 or Matching Placebo | Experimental | Not described Receives: Drug: 1% RO7058584; Drug: Matching Placebo |
| RO7058584 and Latanoprost 0.005% | Experimental | Not described Receives: Drug: 0.01% RO7058584; Drug: 0.1% RO7058584; Drug: 1% RO7058584; Drug: Latanoprost 0.005% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, Severity, and Causal Relationship of Ocular and Systemic Adverse Events (AEs)
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Measured: Up to 12 weeks
Incidence of Abnormal Laboratory Findings
Measured: Up to 12 weeks
Incidence of Blood Pressure Abnormalities
Measured: Up to 12 weeks
Incidence of Pulse Rate Abnormalities
Measured: Up to 12 weeks
Incidence of Electrocardiogram (ECG) Findings
Measured: Up to 12 weeks
Change From Baseline in Mean Intraocular pressure (IOP) After 7 Days of Study Drug Administration
IOP will be assessed by Goldman Applanation tonometry.
Measured: 7 days
Secondary outcomes (5)
Change From Baseline in Mean Intraocular pressure (IOP) at Matched Clock-Times After 7 Days of Study Drug Administration
IOP will be assessed by Goldmann Applanation tonometry
Measured: 7 days
Cmax of RO7058584
Cmax is the maximum observed plasma concentration.
Measured: Up to Day 8
Tmax of RO7058584
Tmax is the time to maximum observed plasma concentration.
Measured: Up to Day 8
Ctrough of RO7058584
Ctrough is the concentration at the end of a dosing interval before the next dose administration.
Measured: Up to Day 8
AUC0-24h of RO7058584
AUC0-24h is the area under the plasma concentration versus time curve (AUC) from Time 0 to 24 h post-dose.
Measured: Up to Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start10 Oct 2017
- Primary completion15 Dec 2017
- Study completion21 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Open-angleStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03293992
- Sponsor's protocol ID
- BP39863
- Status last verified
- Mar 2020
- First submitted
- 21 Sep 2017
- Last updated
- 31 Mar 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multi-Center, Randomized, Adaptive, Investigator/Patient Masked, Multiple-Ascending Dose, Placebo and Active Comparator-Controlled Parallel Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7058584 Following 7 Days of Topical Instillation of Eye Drops in Patients With Primary Open Angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT03293992
- Acronym / sponsor ID
- BP39863
- Conditions
- Glaucoma, Open-angle, Ocular Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 10 Oct 2017 (actual)
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 21 Dec 2017 (actual)
- First posted
- 26 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase I, multi-center, randomized, adaptive, investigator/patient-masked, placebo-controlled, parallel multiple-ascending dose study (Part A) with an extension including up to two selected doses from Part A and latanoprost 0.005% as active comparator (Part B).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0.01% RO7058584 or Matching Placebo | Experimental | Drug: 0.01% RO7058584, Drug: Matching Placebo |
| 0.1% RO7058584 or Matching Placebo | Experimental | Drug: 0.1% RO7058584, Drug: Matching Placebo |
| 1% RO7058584 or Matching Placebo | Experimental | Drug: 1% RO7058584, Drug: Matching Placebo |
| RO7058584 and Latanoprost 0.005% | Experimental | Drug: 0.01% RO7058584, Drug: 0.1% RO7058584, Drug: 1% RO7058584, Drug: Latanoprost 0.005% |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 to 90 years of age inclusive, at the time of signing the informed consent form
- Confirmed diagnosis of ocular hypertension (OHT) or primary open-angle glaucoma (POAG) in both eyes as determined by the investigator at screening
- Treatment-naïve participants or participants who are able to safely stop their Intraocular pressure (IOP)-lowering medication(s) prior to randomization according to the required minimum washout periods
- At baseline visit, IOP ≥ 24 millimeters of mercury (mmHg) in the morning (8:00 AM ± 1h) and ≥ 22 mmHg in the afternoon (2:00 PM ± 1h) measurement in the same eye and ≤ 34 mmHg at all timepoints in both eyes
- Best corrected logarithm of the minimum angle of resolution (logMAR) visual acuity score of 0.7 or better in each eye as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity test at screening
Key exclusion criteria (15 listed)
- Advanced visual field defects
- Other forms of glaucoma than POAG or OHT
- Any abnormality preventing reliable applanation tonometry
- Any clinically significant corneal scarring, haze or opacity
- Uncooperativeness of the participant that restricts adequate examination of IOP, ocular fundus or anterior chamber
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 |
|---|---|---|
| 0.01% RO7058584Once daily morning administration for 7 days | Drug | 0.01% RO7058584 or Matching Placebo, RO7058584 and Latanoprost 0.005% |
| 0.1% RO7058584Once daily morning administration for 7 days | Drug | 0.1% RO7058584 or Matching Placebo, RO7058584 and Latanoprost 0.005% |
| 1% RO7058584Once daily morning administration for 7 days | Drug | 1% RO7058584 or Matching Placebo, RO7058584 and Latanoprost 0.005% |
| Matching PlaceboOnce daily morning administration for 7 days | Drug | 0.01% RO7058584 or Matching Placebo, 0.1% RO7058584 or Matching Placebo, 1% RO7058584 or Matching Placebo |
| Latanoprost 0.005%Once daily morning or evening dosing | Drug | RO7058584 and Latanoprost 0.005% |
Primary outcome
Incidence, Severity, and Causal Relationship of Ocular and Systemic Adverse Events (AEs)
Time frame: Up to 12 weeks
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Incidence of Abnormal Laboratory Findings
Time frame: Up to 12 weeks
Incidence of Blood Pressure Abnormalities
Time frame: Up to 12 weeks
Incidence of Pulse Rate Abnormalities
Time frame: Up to 12 weeks
Incidence of Electrocardiogram (ECG) Findings
Time frame: Up to 12 weeks
Change From Baseline in Mean Intraocular pressure (IOP) After 7 Days of Study Drug Administration
Time frame: 7 days
IOP will be assessed by Goldman Applanation tonometry.
5 secondary outcomes
Change From Baseline in Mean Intraocular pressure (IOP) at Matched Clock-Times After 7 Days of Study Drug Administration
Time frame: 7 days
Cmax of RO7058584
Time frame: Up to Day 8
Tmax of RO7058584
Time frame: Up to Day 8
Ctrough of RO7058584
Time frame: Up to Day 8
AUC0-24h of RO7058584
Time frame: Up to Day 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
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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.
Clinical Trials study director
Hoffmann-La Roche
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 0.01% RO7058584, 0.1% RO7058584 and 1% RO7058584 in people with Glaucoma, Open-angle and Ocular Hypertension, run by Hoffmann-La Roche at 8 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 8 inclusion and 15 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 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence, Severity, and Causal Relationship of Ocular and Systemic Adverse Events (AEs) (time frame: Up to 12 weeks). The study lists 6 primary outcomes in all. 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 31 Mar 2020.