Glaucoma
Conditions
Keywords
Glaucoma
Brief 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).
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.
Interventions
Commercially available ophthalmic solution indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension
Sponsors
Aerie Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * 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 Key
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percent Change From Baseline in Intraocular Pressure (IOP) at Week 12 | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 21 investigative sites located in the United States.
Pre-assignment details
This reporting population includes all participants who received at least 1 dose of study medication.
Participants by arm
| Arm | Count |
|---|---|
| Rocklatan (Latanoprost Mono) Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution, one drop in each eye in the evening for 12 weeks (Latanoprost mono medical therapy regimen) | 61 |
| Rocklatan (Latanoprost +1) Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution, one drop in each eye in the evening for 12 weeks (Latanoprost +1 medical therapy regimen) | 45 |
| Rocklatan (Latanoprost +2) Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution, one drop in each eye in the evening for 12 weeks (Latanoprost +2 medical therapy regimen) | 30 |
| Total | 136 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 4 | 4 | 0 |
| Overall Study | Enrolled in error | 0 | 0 | 1 |
| Overall Study | Investigator Decision | 1 | 0 | 1 |
| Overall Study | Patient Lost to Follow-Up | 0 | 0 | 1 |
| Overall Study | Patient Withdrawal | 2 | 4 | 2 |
Baseline characteristics
| Characteristic | Rocklatan (Latanoprost Mono) | Rocklatan (Latanoprost +1) | Rocklatan (Latanoprost +2) | Total |
|---|---|---|---|---|
| Age, Continuous | 67.4 years STANDARD_DEVIATION 11.2 | 71.1 years STANDARD_DEVIATION 10.06 | 69.3 years STANDARD_DEVIATION 11.6 | 69.0 years STANDARD_DEVIATION 10.97 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants | 7 Participants | 10 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 48 Participants | 38 Participants | 20 Participants | 106 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 2 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Black or African American | 13 Participants | 9 Participants | 11 Participants | 33 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 46 Participants | 32 Participants | 16 Participants | 94 Participants |
| Sex: Female, Male Female | 32 Participants | 23 Participants | 14 Participants | 69 Participants |
| Sex: Female, Male Male | 29 Participants | 22 Participants | 16 Participants | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 61 | 0 / 45 | 0 / 30 |
| other Total, other adverse events | 9 / 61 | 10 / 45 | 6 / 30 |
| serious Total, serious adverse events | 0 / 61 | 0 / 45 | 1 / 30 |
Outcome results
Primary
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.
Time frame: Baseline (Day 0 pretreatment), Week 12
Population: All subjects that received at least 1 follow-up visit with a completed IOP measure and with complete data at both baseline and final visits.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rocklatan (Latanoprost Mono) | Mean Percent Change From Baseline in Intraocular Pressure (IOP) at Week 12 | -21.2 percent change | Standard Deviation 17.46 |
| Rocklatan (Latanoprost +1) | Mean Percent Change From Baseline in Intraocular Pressure (IOP) at Week 12 | -15.7 percent change | Standard Deviation 21.91 |
| Rocklatan (Latanoprost +2) | Mean Percent Change From Baseline in Intraocular Pressure (IOP) at Week 12 | -16.9 percent change | Standard Deviation 17.31 |
| Rocklatan Total | Mean Percent Change From Baseline in Intraocular Pressure (IOP) at Week 12 | -18.5 percent change | Standard Deviation 18.96 |