Eye Drops for Open-Angle Glaucoma

No longer recruiting at 11 trial locations

Overseen By Alcon Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Alcon Research

Must not be taking: Ocular hypotensives

Disqualifiers: Other glaucoma, Glaucoma surgery, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new eye drops for individuals with open-angle glaucoma (OAG) or ocular hypertension (OHT). The goal is to determine if these eye drops are safe and can effectively lower eye pressure. Participants will try different treatments, including AR-17043 (experimental treatment), Latanoprost, and Netarsudil, to identify the most effective option. Those diagnosed with OAG or OHT in both eyes and currently managing high eye pressure with no more than two medications might be suitable candidates. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in eye care.

Will I have to stop taking my current medications?

The trial requires that you are not using more than 2 eye pressure-lowering medications within 30 days before joining. If you are on more than 2, you may need to stop some of them.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the treatments tested in this trial—AR-17043, Latanoprost, and Netarsudil—are generally safe for people.

For AR-17043, studies of similar treatments with Netarsudil and Latanoprost suggest they are well-tolerated. These treatments have been studied before and have a good safety record, with most people not experiencing serious side effects.

Latanoprost is already used to treat open-angle glaucoma and is usually safe for most patients. Studies have shown it causes fewer eye-related side effects compared to other similar treatments.

Netarsudil is also used for treating glaucoma and has been shown to be safe for most people. Common side effects might include mild eye redness, but serious problems are rare.

Since this is a Phase 2 trial, researchers are still closely studying the safety of these treatments, but past research provides a reassuring picture of their safety in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for open-angle glaucoma, which often involve medications like Latanoprost or Netarsudil, the investigational treatment AR-17043 offers a potentially new mechanism of action. Researchers are excited about AR-17043 because it comes in various concentrations, allowing for tailored treatments that could optimize efficacy and minimize side effects. Additionally, it offers flexibility in dosing schedules, which might improve patient adherence compared to traditional therapies. This novel approach could significantly enhance how we manage glaucoma, offering hope for better pressure control in the eyes.

What evidence suggests that this trial's treatments could be effective for open-angle glaucoma or ocular hypertension?

Research shows that AR-17043 eye drops, one of the treatments in this trial, are being evaluated for their ability to lower eye pressure in people with open-angle glaucoma or ocular hypertension. Early results suggest that AR-17043 may help reduce eye pressure, which is crucial for managing these conditions.

Studies have found that Latanoprost, another treatment option in this trial, lowers eye pressure by about 20-30% and is a well-known treatment for open-angle glaucoma. It is widely used because it works well for many patients.

Netarsudil, also tested in this trial, has significantly lowered eye pressure, especially in patients whose initial pressure is 20 mmHg or lower. This makes it a strong choice for controlling eye pressure. All treatments in the trial aim to reduce eye pressure, which is key in treating glaucoma and ocular hypertension. ^{1 3 4 6 7}

Who Is on the Research Team?

Clinical Trial Lead, Pharma

Principal Investigator

Alcon Research, LLC

Are You a Good Fit for This Trial?

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

Other protocol-specified inclusion criteria may apply

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.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Stage 1

Participants receive one of the five treatments for 7 days: 3 concentrations of AR-17043, placebo, or netarsudil 0.02%

1 week

Daily visits for IOP measurement

Treatment Stage 2

Participants receive one of the five treatments for 28 days: low/high concentrations of PG043, AR-17043 high concentration, latanoprost, or Rocklatan

4 weeks

Weekly visits for IOP measurement

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AR-17043
• Latanoprost
• Netarsudil

Trial Overview 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.

How Is the Trial Designed?

Group I: PG043 low concentration (Stage 2) Experimental Treatment 1 Intervention

PG043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.

Group II: PG043 high concentration (Stage 2) Experimental Treatment 1 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 Treatment 1 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 Treatment 1 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 Treatment 1 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 Control 1 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 Control 1 Intervention

AR-17043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.

Group VIII: Latanoprost (Stage 2) Active Control 1 Intervention

Latanoprost 0.005% Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.

Group IX: Rocklatan (Stage 2) Active Control 1 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 Group 1 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.

Who Is Running the Clinical Trial?

Alcon Research

Lead Sponsor

Trials

739

Recruited

128,000+

Raquel C. Bono

Alcon Research

Chief Medical Officer since 2022

MD from Harvard Medical School

David Endicott

Alcon Research

Chief Executive Officer since 2018

MBA from University of Southern California

Published Research Related to This Trial

Rhopressa (netarsudil) is an effective treatment for open-angle glaucoma that works by inhibiting norepinephrine transport and Rho-associated protein kinase (ROCK), but it can cause side effects like conjunctival hyperemia.

This case report highlights a unique instance of Rhopressa-induced corneal edema in a 79-year-old woman without prior corneal issues, suggesting that there may be unknown effects of the treatment that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rhopressa-induced corneal edema: a case report. Chu, MJ., Song, M., Palmares, T., et al.[2021]

Netarsudil ophthalmic solution 0.02% effectively lowers intraocular pressure (IOP) in patients with open-angle glaucoma and ocular hypertension, showing a reduction of 16%-21% in IOP in clinical trials compared to other common treatments.

In combination with Latanoprost, Netarsudil led to a significant 64.5% of patients achieving a ≥30% reduction in mean diurnal IOP, while the most common side effect, conjunctival hyperemia, did not significantly impact patient tolerance to the drug.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[ROCK (RHO-KINASE INHIBITORS) FOR THE TREATMENT OF OPEN-ANGLE GLAUCOMA AND OCULAR HYPERTENSION]. Hayat, H., Achiron, A., Masarwa, D., et al.[2023]

Netarsudil/latanoprost fixed-dose combination therapy significantly reduces intraocular pressure (IOP) more than latanoprost alone, with a mean difference of -2.41 mmHg after 2 weeks and -1.77 mmHg after 4 to 6 weeks, based on a meta-analysis of four studies.

While the combination therapy is effective, it is associated with a higher risk of conjunctival hyperemia compared to latanoprost alone, although the symptoms are generally mild and lead to few discontinuations among patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Netarsudil/Latanoprost Therapy with Latanoprost Monotherapy for Lowering Intraocular Pressure: A Systematic Review and Meta-analysis. Lee, JW., Ahn, HS., Chang, J., et al.[2022]

A study involving 266 patients with ocular hypertension or primary open-angle glaucoma showed that Bausch & Lomb's latanoprost 0.005% eyedrops effectively reduced intraocular pressure (IOP) similarly to Xalatan, with both treatments achieving comparable IOP reductions over 6 weeks.

The trial confirmed that latanoprost was noninferior to Xalatan, meaning it works just as well, and both medications had similar safety and tolerability profiles, making them equally viable options for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Latanoprost 0.005% test formulation is as effective as Xalatan® in patients with ocular hypertension and primary open-angle glaucoma. Allaire, C., Dietrich, A., Allmeier, H., et al.[2018]

In a 28-day study involving 224 patients with open-angle glaucoma or ocular hypertension, AR-13324 demonstrated a reduction in intraocular pressure (IOP) but was less effective than latanoprost, with a 5.7 mmHg decrease compared to latanoprost's 6.8 mmHg.

The most common side effect of AR-13324 was ocular hyperemia, occurring in 52% to 57% of patients, which was significantly higher than the 16% incidence seen with latanoprost.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Double-masked, randomized, dose-response study of AR-13324 versus latanoprost in patients with elevated intraocular pressure. Bacharach, J., Dubiner, HB., Levy, B., et al.[2022]

The fixed-dose combination (FDC) of netarsudil 0.02% and latanoprost 0.005% significantly lowered intraocular pressure (IOP) more effectively than either medication alone, with reductions of 2.2 to 3.3 mmHg compared to netarsudil and 1.5 to 2.4 mmHg compared to latanoprost over a 3-month period.

The FDC was well-tolerated, with no serious treatment-related adverse events reported, and the most common side effect, conjunctival hyperemia, was generally mild, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Once-Daily Netarsudil/Latanoprost Fixed-Dose Combination for Elevated Intraocular Pressure in the Randomized Phase 3 MERCURY-2 Study. Walters, TR., Ahmed, IIK., Lewis, RA., et al.[2021]

The fixed-dose combination of netarsudil 0.02% and latanoprost 0.005% is effective in significantly reducing intraocular pressure (IOP) in patients with open-angle glaucoma and ocular hypertension, with 59-65% of subjects achieving a reduction of 30% or greater in clinical trials.

This combination therapy was well tolerated, showing mostly mild ocular side effects and limited systemic effects, making it a safe option for patients compared to the individual components.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Netarsudil/latanoprost fixed-dose combination for the treatment of open-angle glaucoma or ocular hypertension. Radell, JE., Serle, JB.[2019]

Latanoprost is an effective treatment for lowering intraocular pressure (IOP) in patients with open-angle glaucoma and ocular hypertension, achieving a reduction of up to 35% over at least two years, and is comparable or slightly more effective than timolol.

The drug is applied topically at a low dose of 0.005% once daily, and due to its rapid metabolism outside the eye, it has minimal systemic side effects, although it can cause increased iris pigmentation in some patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Latanoprost in the treatment of glaucoma and ocular hypertension. Watson, PG.[2019]

Netarsudil ophthalmic solution 0.02% effectively lowers intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, showing significant reductions in IOP comparable to the standard treatment of twice-daily timolol over three months in phase III trials.

The most common side effect was mild conjunctival hyperemia, which did not worsen with continued use, and netarsudil had minimal serious or systemic adverse effects, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Netarsudil ophthalmic solution 0.02% for the treatment of patients with open-angle glaucoma or ocular hypertension. Kopczynski, CC., Heah, T.[2019]

Latanoprost (Xalatan) monotherapy significantly reduces intraocular pressure (IOP) in patients with primary open angle glaucoma (POAG), with an average decrease of 5.1 mmHg after 60 days of treatment.

As a once-daily treatment, latanoprost improves patient compliance compared to other drug combinations, while also offering effective IOP control and fewer side effects, potentially reducing the need for surgical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of latanoprost (Xalatan) monotherapy in newly discovered and previously medicamentously treated primary open angle glaucoma patients. Pavan, J., Stambuk, N., Curković, T., et al.[2018]

Citations

1. clinicaltrial.be clinicaltrial.be/en/details/438427?per_page=20&only_recruiting=0&only_eligible=0

Next Generation Rocklatan 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.

2. withpower.com withpower.com/trial/phase-2-glaucoma-8-2024-dd77e

Eye Drops for Open-Angle Glaucoma · Info for Participants 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- ...

3. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT06441643/

Trial | NCT06441643 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- ...

4. app.trialscreen.org app.trialscreen.org/trials/phase-2-next-generation-rocklatan-trial-nct06441643

Next Generation Rocklatan A Phase 2 interventional study of AR-17043 and PG043 in glaucoma/ocular hypertension. Evaluating the Safety and Effectiveness of New Eye Drops for Glaucoma and ...

5. ctv.veeva.com ctv.veeva.com/study/next-generation-rocklatan

Next Generation Rocklatan - ClinicalTrials.Veeva 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- ...

6. pharmaceutical-technology.com pharmaceutical-technology.com/data-insights/ar-17043-alcon-ocular-hypertension-likelihood-of-approval/

AR-17043 by Alcon for Ocular Hypertension: Likelihood of ... AR-17043 is under development for the treatment of open-angle glaucoma (OAG) and ocular hypertension (OHT). It is administered through ophthalmic route.

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06441643/next-generation-rocklatan

Next Generation Rocklatan | Clinical Research Trial Listing The purpose of this two-stage clinical trial is to assess the safety and hypotensive efficacy of AR-17043 and PG043 ophthalmic solutions in ...