Eye Drops for Open-Angle Glaucoma
Recruiting in Palo Alto (17 mi)
+11 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Alcon Research
Prior Safety Data
Trial Summary
What is the purpose of this trial?The purpose of this two-stage clinical trial is to assess the safety and hypotensive efficacy of AR-17043 and PG043 ophthalmic solutions in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT).
Is the drug AR-17043, Latanoprost, Netarsudil a promising treatment for open-angle glaucoma?Yes, the drug AR-17043, which includes Latanoprost and Netarsudil, is promising for treating open-angle glaucoma. It effectively lowers eye pressure, with studies showing significant reductions when used together. This combination is more effective than using each drug alone, making it a strong option for managing this condition.123610
Do I have to stop taking my current medications for the trial?The trial does not specify if you must stop all current medications, but you cannot use more than 2 ocular hypotensive medications within 30 days before the trial.
What safety data is available for eye drops used to treat open-angle glaucoma?The safety of Netarsudil, a Rho kinase inhibitor, has been evaluated in several clinical trials, including the ROCKET and MERCURY trials. These studies compared Netarsudil to other treatments like Timolol and Latanoprost. The most common adverse event was mild conjunctival hyperemia, with minimal serious or systemic adverse events reported. The combination of Netarsudil and Latanoprost was also studied, showing significant efficacy in reducing intraocular pressure with a similar safety profile.457910
What data supports the idea that Eye Drops for Open-Angle Glaucoma is an effective treatment?The available research shows that the eye drops containing netarsudil and latanoprost are effective in reducing eye pressure in patients with open-angle glaucoma. In clinical trials, using netarsudil alone reduced eye pressure by 16%-21%. When combined with latanoprost, 64.5% of patients experienced a 30% or greater reduction in eye pressure, compared to 28.8% with netarsudil alone and 37.2% with latanoprost alone. This combination was more effective than using either drug by itself.567810
Eligibility Criteria
This trial is for individuals with open-angle glaucoma or ocular hypertension. Participants should have a specific level of eye pressure and vision capability, and be able to administer eye drops themselves or with help. Those who've had certain eye treatments or conditions that could affect the study's outcome can't join.Inclusion Criteria
I have been diagnosed with open-angle glaucoma or high eye pressure in both eyes.
My eye pressure is high without medication, as defined in the study.
My vision in the study eye is at least 20/200.
I have been diagnosed with open-angle glaucoma or high eye pressure in both eyes.
My untreated eye pressure is high as per the study's criteria.
My vision in the study eye is at least 20/100.
Exclusion Criteria
I am using more than 2 eye pressure-lowering medications.
I don't have any conditions that would prevent accurate medical measurements.
I struggle to put in eyedrops correctly.
My eye pressure is over 36 mmHg.
My glaucoma is not open-angle type and is in early stages.
I have had surgery for glaucoma.
Participant Groups
The trial is testing the safety and effectiveness of two ophthalmic solutions: AR-17043 and PG043, in lowering eye pressure for patients with open-angle glaucoma or ocular hypertension. It compares these new treatments against other known medications like Netarsudil and Latanoprost.
10Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: PG043 low concentration (Stage 2)Experimental Treatment1 Intervention
PG043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.
Group II: PG043 high concentration (Stage 2)Experimental Treatment1 Intervention
PG043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.
Group III: AR-17043 medium concentration (Stage 1)Experimental Treatment1 Intervention
AR-17043 Ophthalmic Solution, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7.
Group IV: AR-17043 low concentration (Stage 1)Experimental Treatment1 Intervention
AR-17043 Ophthalmic Solution, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7.
Group V: AR-17043 high concentration (Stage 1)Experimental Treatment1 Intervention
AR-17043 Ophthalmic Solution, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7.
Group VI: Rhopressa (Stage 1)Active Control1 Intervention
Netarsudil 0.02% Ophthalmic Solution, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7.
Group VII: AR-17043 high concentration (Stage 2)Active Control1 Intervention
AR-17043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.
Group VIII: Latanoprost (Stage 2)Active Control1 Intervention
Latanoprost 0.005% Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.
Group IX: Rocklatan (Stage 2)Active Control1 Intervention
Netarsudil 0.02%/Latanoprost 0.005% Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.
Group X: AR-17043 vehicle (Stage 1)Placebo Group1 Intervention
AR-17043 Vehicle, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Orange County Ophthalmology Medical GroupGarden Grove, CA
United Medical Research InstituteInglewood, CA
North Bay Eye AssociatesPetaluma, CA
Rochester Ophthalmological GroupRochester, NY
More Trial Locations
Loading ...
Who is running the clinical trial?
Alcon ResearchLead Sponsor
References
Latanoprost in the treatment of glaucoma and ocular hypertension. [2019]Latanoprost (Xalatan) is a prostaglandin F(2alpha) analog prodrug which is activated when hydrolyzed in the cornea and plasma. Latanoprost reduces the intraocular pressure (IOP) by increasing uveoscleral outflow. Other locally applied medications reduce IOP either by increasing the outflow of fluid through the trabecular drainage system or by reducing the production of fluid in the eye. Latanoprost, which is used topically in the eye at the low dose of 0.005% once daily, has been shown in phase III studies carried out in Scandinavia, the U.K. and the U.S. to be capable of lowering the IOP in patients with open-angle glaucoma and ocular hypertension by 35%. This low IOP is maintained over at least a 2-year period. Latanaprost is as effective, or possible slightly more effective than timolol in its pressure reducing effects. Additional pressure reduction can be achieved by adding latanoprost to existing glaucoma medications. Because latanoprost is rapidly metabolized outside the eye, systemic side effects do not occur. Increased iris pigmentation occurs in at least 10% of hazel (but not blue or dark-eyed patients). So far no ocular problem has occurred because of the increased production of pigment which is not released from the iris. Isolated cases of cystoid macular edema have occurred, so that anyone complaining of reduction of vision while using the drug should be fully investigated.
Effectiveness of latanoprost (Xalatan) monotherapy in newly discovered and previously medicamentously treated primary open angle glaucoma patients. [2018]We evaluated the effectiveness of latanoprost (Xalatan) monotherapy in primary open angle glaucoma (POAG). Latanoprost is a prostaglandin analogue, the pure 15(R) epimer of 13,14-dihydro-17-phenyl-18,19,20-trinor-PGF2alpha-isopropyl ester. As a prodrug it is being activated by enzymatic hydrolysis in the cornea after which it becomes active acid of latanoprost. Latanoprost is lowering the intraocular pressure (IOP) by increasing the uveoscleral outflow. In this study, latanoprost was used once daily as monotherapy what offers much better compliance for the patients than other combinations of drugs, preserving good IOP control. Based on the significant reduction of the IOP, measured on the day 60 of the trial (mean change in IOP was -5.1 mmHg, with 95% confidence interval in range from -5.6 to -4.5), it is concluded that use of latanoprost is advisable when calculating better IOP control, few side-effects and reductions in costs of potential surgical procedures.
Latanoprost 0.005% test formulation is as effective as Xalatan® in patients with ocular hypertension and primary open-angle glaucoma. [2018]To determine if a test formulation of latanoprost 0.005% (Bausch & Lomb) eyedrops reduced intraocular pressure (IOP) as well as Xalatan® (latanoprost 0.005%) in patients with ocular hypertension (OH) or primary open-angle glaucoma (POAG).
Double-masked, randomized, dose-response study of AR-13324 versus latanoprost in patients with elevated intraocular pressure. [2022]AR-13324 is a small-molecule inhibitor of Rho kinase and a norepinephrine transporter. The objective of this 28-day study was to evaluate the ocular hypotensive efficacy and safety of AR-13324 ophthalmic solution compared with a positive control, latanoprost ophthalmic solution, in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).
Netarsudil ophthalmic solution 0.02% for the treatment of patients with open-angle glaucoma or ocular hypertension. [2019]Once-daily (p.m.) netarsudil ophthalmic solution 0.02% (Rhopressa) is approved in the United States for lowering elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Netarsudil, a Rho kinase (ROCK) inhibitor that lowers IOP primarily by increasing trabecular outflow, produces statistically and clinically significant reductions in mean IOP from baseline, with comparable effects on nocturnal and diurnal IOP. In three phase III trials of patients with elevated IOP, the ocular hypotensive efficacy of once-daily netarsudil 0.02% met the criteria for noninferiority to twice-daily timolol 0.5% at all time points over 3 months in patients with baseline IOP less than 25 mmHg. The most frequent adverse event (AE) was generally mild conjunctival hyperemia, the severity of which did not increase with continued dosing. Netarsudil was associated with minimal treatment-related serious or systemic AEs, likely due to the lack of systemic exposure. This report summarizes the available preclinical and clinical data on netarsudil.
Netarsudil/latanoprost fixed-dose combination for the treatment of open-angle glaucoma or ocular hypertension. [2019]The fixed-dose combination (FDC) of netarsudil 0.02%/ latanoprost 0.005% was approved by the United States Food and Drug Administration (FDA) on March 12, 2019, for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) and ocular hypertension (OHT). Netarsudil is a Rho kinase (ROCK) inhibitor and latanoprost is a prostaglandin analogue (PGA). Once-daily administration of this FDC reduces IOP by enhancing aqueous outflow through both the trabecular pathways (ROCK inhibition) and uveoscleral pathways (PGA). Two phase III clinical trials, MERCURY-1 and MERCURY-2, confirmed significantly greater efficacy of the FDC than the individual components, with IOP reductions of 30% or greater observed in 59-65% of subjects treated with FDC compared with 29-37% of subjects treated with latanoprost alone and 21-29% of subjects treated with netarsudil alone. The FDC was well tolerated with mostly mild ocular side effects and limited systemic side effects. This paper will review the work leading to FDA approval and the clinical indications for the use of this combination.
Once-Daily Netarsudil/Latanoprost Fixed-Dose Combination for Elevated Intraocular Pressure in the Randomized Phase 3 MERCURY-2 Study. [2021]To compare the ocular hypotensive efficacy and safety of a once-daily (pm) fixed-dose combination (FDC) product containing netarsudil 0.02% and latanoprost 0.005% with monotherapy with netarsudil or latanoprost. Netarsudil is a Rho kinase inhibitor that lowers intraocular pressure (IOP) primarily by increasing trabecular (conventional) outflow. Latanoprost is the most frequently prescribed of the prostaglandin analogs, which lower IOP primarily by increasing uveoscleral outflow.
Rhopressa-induced corneal edema: a case report. [2021]Rhopressa (netarsudil) has recently been added to the arsenal of treatment for open-angle glaucoma. It is an effective norepinephrine transporter and Rho-associated protein kinase (ROCK) inhibitor used to decrease intraocular pressure (IOP), with the most common side effect being conjunctival hyperemia.
Comparison of Netarsudil/Latanoprost Therapy with Latanoprost Monotherapy for Lowering Intraocular Pressure: A Systematic Review and Meta-analysis. [2022]Netarsudil is a Rho kinase inhibitor and the first new class of clinically useful ocular hypotensive agents. In this study, we conducted a systematic literature review and meta-analysis to summarize and synthesize the available evidence on the efficacy and safety of fixed-dose combination (FDC) therapy with netarsudil/latanoprost in patients with glaucoma.
[ROCK (RHO-KINASE INHIBITORS) FOR THE TREATMENT OF OPEN-ANGLE GLAUCOMA AND OCULAR HYPERTENSION]. [2023]Netarsudil ophthalmic solution 0.02% is a new treatment for open-angle glaucoma and ocular hypertension, which was approved for treatment in the United States and in the European Commission. The drug is a rho- kinase inhibitor (ROCK) that lowers intraocular pressure by enhancing the outflow at the trabecular meshwork and decreasing both aqueous humor production and episcleral venous pressure. This literature review aims to present this new treatment, characterize its specific mechanism of action, and discuss its effect and adverse events profile. The efficacy and safety of the drug were studied in the ROCKET and MERCURY clinical trials, in which Netarsudil was compared to other common drugs, including Timolol (Beta-blocker), Latanoprost (Prostaglandin analog), and a combination drop containing Netarsudil and Latanoprost. These trials showed a reduction of 16%-21% in the intraocular pressure (IOP) when using Netarsudil. Moreover, it was found that when using a combination of Netarsudil and Latanoprost, 64.5% of these patients achieved ≥30% reduction in mean diurnal IOP versus 28.8% of patients treated only with Netarsudil and 37.2% of patients treated only with Latanoprost (P