GlaucomaPhase 4NCT05283395
Rocklatan® Evaluation
A Phase 4 study testing Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution in people with Glaucoma, run by Aerie Pharmaceuticals at 21 sites in United States.
Trial summary
The objective of this study is to evaluate the IOP-lowering effect when subjects are switched from various latanoprost-based regimens to Rocklatan. Subjects will stop their IOP-lowering medical therapy regimen and dose with Rocklatan for the duration of the study (12 weeks). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 21 sitesUnited States
- Study dates
- 28 Mar 2022to 22 Mar 2023
- Phase
- Phase 4
- 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
- Male or female subjects age 18 or older
- Current diagnosis of open-angle glaucoma or ocular hypertension
- Subject currently being treated with latanoprost alone or latanoprost plus 1 or 2 additional agents/bottles. Current IOP lowering regimen is stable for at least 30 days prior to Baseline Visit
- Treated IOP ≥ 20 mmHg measured in the morning (before noon) at the Baseline Visit by Goldmann applanation tonometer
- Best corrected Snellen visual acuity of 20/100 or better in both eyes
- Willingness to follow protocol requirements, including signed informed consent and health information release forms, routine follow-up schedule, completing questionnaires
Who cannot join
- Have any active ocular disease other than open-angle glaucoma or ocular hypertension that would interfere with study interpretation
- Use of fixed dose combination agents as part of the patient's Baseline IOP lowering therapy regimen, if not also on latanoprost
- Active ocular infection/inflammation or history of uveitis
- Aphakic or pseudophakic patients with a torn posterior lens capsule, or with known risk factors for macular edema
- Any systemic disease or clinical evidence of any condition which would make the subject, in the opinion of the investigator, unsuitable for the study or could potentially confound the study results
- Use of topical, periorbital, intravitreal or systemic steroid within previous 3 months or expected use during the course of the study
Show all 11Show fewer
- Prior participation in any investigational drug or device study within the last 30 days prior to the Baseline Visit.
- Known sensitivity or allergy to the study medication or components
- Females who are pregnant, nursing, or planning a pregnancy during the study
- Positive pregnancy test at Baseline Visit (women of childbearing potential only)
- Women of childbearing potential who are not using a medically acceptable form of birth control
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Georgia Eye Partners
Atlanta, Georgia, 30342
Keystone Research
Austin, Texas, 78731
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, 16066
Louis M. Alpern, M.D., M.P.H., P.A
El Paso, Texas, 79902
Emerson Clinical Research Institute
Falls Church, Virginia, 22046
Advancing Vision Research
Goodlettsville, Tennessee, 37072
Houston Eye Associates
Houston, Texas, 77025
Shettle Eye Research
Largo, Florida, 33773
OCLI Vision
Manhasset, New York, 11030
VRF Eye Specialty Group
Memphis, Tennessee, 38120
Total Eye Care, PA
Memphis, Tennessee, 38199
North Valley Eye Medical Group
Mission Hills, California, 91345
Visionary Eye Institute
Newport Beach, California, 92663
California Eye Specialists Medical Group
Pasadena, California, 91107
North Bay Eye Associates
Petaluma, California, 94954
The Eye Centers of Racine and Kenosha
Racine, Wisconsin, 53405
Vistar Eye Center
Roanoke, Virginia, 24016
Coastal Research Associates LLC
Roswell, Georgia, 30076
Tekwani Vision Center
St Louis, Missouri, 63128
Mark J. Weiss, MD, Inc.
Tulsa, Oklahoma, 74104
Center For Sight
Venice, Florida, 34285
About this study
Official title: A Multicenter, Open-Label Rocklatan® (Netarsudil/Latanoprost Ophthalmic Solution) 0.02%/0.005% Evaluation of IOP Lowering Efficacy and Safety as Replacement of Current Medical Therapy Regimen for the Reduction of Elevated Intraocular Pressure in Patients With Glaucoma or Ocular Hypertension
The objective of this study is to evaluate the IOP-lowering effect when subjects are switched from various latanoprost-based regimens to Rocklatan. Subjects will stop their IOP-lowering medical therapy regimen and dose with Rocklatan for the duration of the study (12 weeks).
Read the detailed description
Enrollment will be stratified according to subject's IOP-lowering medical therapy regimen as follows:
- Latanoprost monotherapy (Latanoprost Mono)
- Latanoprost plus 1 additional IOP-lowering agent (Latanoprost +1)
- Latanoprost plus 2 additional IOP-lowering agents (Latanoprost +2)
Aerie Pharmaceuticals was acquired by Alcon Research LLC on November 22, 2022.
- Conditions
- Glaucoma
- Being tested
- Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution
- Keywords
- Glaucoma
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solutionDrug
Also called Rocklatan®
Commercially available ophthalmic solution indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension
| Study group | Role | What they receive |
|---|---|---|
| Rocklatan | Experimental | Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution, one drop in each eye in the evening for 12 weeks Receives: Drug: Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percent Change From Baseline in Intraocular Pressure (IOP) at Week 12
IOP was measured using Goldmann applanation tonometry at the Baseline and Week 12 visits. One eye (study eye) contributed data to this analysis. A negative value indicates an improvement in IOP. No hypothesis testing was prespecified for this endpoint.
Measured: Baseline (Day 0 pretreatment), Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start28 Mar 2022
- Primary completion22 Mar 2023
- Study completion22 Mar 2023
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aerie Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scientific Advisor, Clinical R&D, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05283395
- Sponsor's protocol ID
- MA-ROC-22-003
- Status last verified
- Jan 2024
- First submitted
- 7 Mar 2022
- Last updated
- 3 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label Rocklatan® (Netarsudil/Latanoprost Ophthalmic Solution) 0.02%/0.005% Evaluation of IOP Lowering Efficacy and Safety as Replacement of Current Medical Therapy Regimen for the Reduction of Elevated Intraocular Pressure in Patients With Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT05283395
- Acronym / sponsor ID
- MA-ROC-22-003
- Conditions
- Glaucoma
- Keywords
- Glaucoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Aerie PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 22 Mar 2023 (actual)
- Study completion
- 22 Mar 2023 (actual)
- First posted
- 17 Mar 2022 (actual)
- Results
- Posted 3 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the IOP-lowering effect when subjects are switched from various latanoprost-based regimens to Rocklatan. Subjects will stop their IOP-lowering medical therapy regimen and dose with Rocklatan for the duration of the study (12 weeks).
Detailed description
Enrollment will be stratified according to subject's IOP-lowering medical therapy regimen as follows:
- Latanoprost monotherapy (Latanoprost Mono)
- Latanoprost plus 1 additional IOP-lowering agent (Latanoprost +1)
- Latanoprost plus 2 additional IOP-lowering agents (Latanoprost +2)
Aerie Pharmaceuticals was acquired by Alcon Research LLC on November 22, 2022.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rocklatan | Experimental | Drug: Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solutionNetarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution, one drop in each eye in the evening for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female subjects age 18 or older
- Current diagnosis of open-angle glaucoma or ocular hypertension
- Subject currently being treated with latanoprost alone or latanoprost plus 1 or 2 additional agents/bottles. Current IOP lowering regimen is stable for at least 30 days prior to Baseline Visit
- Treated IOP ≥ 20 mmHg measured in the morning (before noon) at the Baseline Visit by Goldmann applanation tonometer
- Best corrected Snellen visual acuity of 20/100 or better in both eyes
Key exclusion criteria (11 listed)
- Have any active ocular disease other than open-angle glaucoma or ocular hypertension that would interfere with study interpretation
- Use of fixed dose combination agents as part of the patient's Baseline IOP lowering therapy regimen, if not also on latanoprost
- Active ocular infection/inflammation or history of uveitis
- Aphakic or pseudophakic patients with a torn posterior lens capsule, or with known risk factors for macular edema
- Any systemic disease or clinical evidence of any condition which would make the subject, in the opinion of the investigator, unsuitable for the study or could potentially confound the study results
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 |
|---|---|---|
| Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solutionAlso: Rocklatan®Commercially available ophthalmic solution indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension | Drug | Rocklatan |
Primary outcome
Mean Percent Change From Baseline in Intraocular Pressure (IOP) at Week 12
Time frame: Baseline (Day 0 pretreatment), Week 12
IOP was measured using Goldmann applanation tonometry at the Baseline and Week 12 visits. One eye (study eye) contributed data to this analysis. A negative value indicates an improvement in IOP. No hypothesis testing was prespecified for this endpoint.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Scientific Advisor, Clinical R&D study director
Alcon Research, LLC
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution in people with Glaucoma, run by Aerie Pharmaceuticals at 21 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 6 inclusion and 11 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 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 3 Apr 2024). 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?
Mean Percent Change From Baseline in Intraocular Pressure (IOP) at Week 12 (time frame: Baseline (Day 0 pretreatment), Week 12). 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 3 Apr 2024.