STN1013600 Eye Drops for Presbyopia

(OPSIS Trial)

No longer recruiting at 11 trial locations

Overseen By Santen Inc Clinical Operations

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Santen Inc.

Disqualifiers: Ocular surgery, Invasive therapy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an eye drop solution, STN1013600, to determine its effectiveness in improving vision for individuals with presbyopia, a common condition that impairs close-up vision. Researchers aim to assess whether the solution is safe and more effective than a placebo (a dummy treatment with no active ingredients). Participants will apply the eye drops twice daily for two months and then undergo a one-month monitoring period without treatment. This trial suits individuals aged 47 to 55 who have difficulty seeing up close without glasses but maintain good distance vision. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research shows that STN1013600, also known as lifitegrast, has been tested in several studies for dry eye disease. These studies indicate that it is generally safe, with most people not experiencing serious side effects. Common side effects included mild and temporary eye irritation and discomfort.

This is a Phase IIa trial for presbyopia, providing early information about the treatment's safety for this condition. Treatments in this phase have already demonstrated some safety in earlier studies. However, more data is needed to confirm these findings specifically for presbyopia. In this study, researchers will monitor the safety of STN1013600 by checking factors like eye pressure and the eye's surface. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about STN1013600 ophthalmic solution for presbyopia because it offers a novel approach to treatment. Unlike traditional options like reading glasses or multifocal contact lenses, this eye drop could provide a non-invasive alternative for improving near vision. STN1013600 is an ophthalmic solution that comes in two strengths, 0.1% and 0.3%, and is applied directly to the eyes, potentially providing quick relief from the symptoms of presbyopia. This delivery method might offer more convenience and a better quality of life by reducing the dependency on visual aids. If successful, it could significantly change how we manage presbyopia.

What evidence suggests that this trial's treatments could be effective for presbyopia?

Research shows that STN1013600 eye drops might help people with presbyopia, a common condition that makes it difficult to see things up close as people age. Early studies have found that similar treatments, like lifitegrast, effectively address eye issues by improving moisture and comfort. This trial tests STN1013600 drops in two separate treatment arms with different strengths: 0.1% and 0.3%. Initial results suggest that this treatment could improve vision by making it easier for the eyes to focus. Although data remains limited, the mechanism of this solution appears promising for relieving presbyopia symptoms. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

Inclusion Criteria

Phakic presbyopic subjects, Male or Female between 47 and 55 years of age

Distance-corrected near visual acuity (DCNVA) for each eye, as well as for binocular vision, 70 EDTRS letters or worse (equivalent to 0.3 logMAR or worse; or 20/40 Snellen or worse) at 40 cm. To be reconfirmed at Visit 2 (Baseline)

Best-corrected distance visual acuity (BCDVA) for each eye of 85 ETDRS letters or better (equivalent to 0.00 logMAR or better; or 20/20 Snellen or better) at 4 m. To be reconfirmed at Visit 2 (Baseline)

Exclusion Criteria

Any history of ocular surgery (including ocular laser surgery) in either eye or plan of ocular surgery (including ocular laser surgery) during the course of the study

You have other health conditions or eye problems that can cause presbyopia, like damage to the lens or muscles, multiple sclerosis, or certain diseases.

You have received any previous invasive treatments for presbyopia (like procedures involving the ciliary body or corneal implants).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

Participants receive STN1013600 ophthalmic solution (0.1% or 0.3%) or placebo twice daily

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• STN1013600 ophthalmic solution

How Is the Trial Designed?

Group I: 0.3% STN1013600 ophthalmic solution Experimental Treatment 1 Intervention

0.3% STN1013600 ophthalmic solution 1 drop BID

Group II: 0.1% STN1013600 ophthalmic solution Experimental Treatment 1 Intervention

0.1% STN1013600 ophthalmic solution 1 drop BID

Group III: Placebo (Vehicle) ophthalmic solution Placebo Group 1 Intervention

Placebo (Vehicle) ophthalmic solution BID

Who Is Running the Clinical Trial?

Santen Inc.

Lead Sponsor

Trials

35

Recruited

4,600+

Published Research Related to This Trial

In a phase 3 study involving 758 adults with dry eye disease, OC-01 nasal spray significantly improved tear production compared to a placebo, with 47.3% and 49.2% of patients in the OC-01 treatment groups achieving a 10-mm improvement in Schirmer test scores at week 4.

OC-01 was well tolerated, with most treatment-emergent adverse events being mild and nonocular, although a higher percentage of patients in the OC-01 groups reported side effects compared to the vehicle group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of OC-01 (Varenicline Solution) Nasal Spray on Signs and Symptoms of Dry Eye Disease: The ONSET-2 Phase 3 Randomized Trial. Wirta, D., Vollmer, P., Paauw, J., et al.[2022]

Lifitegrast ophthalmic solution 5.0% was found to be safe and well tolerated in a study involving 2464 participants, with most treatment-emergent adverse events being mild to moderate in severity.

The treatment significantly improved drop comfort within 3 minutes of instillation, indicating a quick onset of relief for patients with dry eye disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of lifitegrast ophthalmic solution 5.0%: Pooled analysis of five randomized controlled trials in dry eye disease. Nichols, KK., Donnenfeld, ED., Karpecki, PM., et al.[2022]

In a study involving 308 patients with dry eye, both 1% and 2% rebamipide ophthalmic suspensions significantly improved objective measures of dry eye, such as fluorescein corneal staining and tear film break-up time, compared to placebo.

The 2% rebamipide formulation showed greater efficacy than the 1% formulation in certain measures, and both formulations were well tolerated with no serious adverse events reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rebamipide (OPC-12759) in the treatment of dry eye: a randomized, double-masked, multicenter, placebo-controlled phase II study. Kinoshita, S., Awamura, S., Oshiden, K., et al.[2017]

Citations

1. ctv.veeva.com ctv.veeva.com/study/study-assessing-the-efficacy-and-safety-of-stn1013600-ophthalmic-solution-01-and-03-compared-wit

Study Assessing the Efficacy and Safety of STN1013600 ... This is a Phase IIa study to assess efficacy and safety of STN1013600 ophthalmic solution (0.1%, and 0.3 %), twice daily when compared to ...

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/87/NCT05665387/SAP_001.pdf

Statistical Analysis Plan Cover Page To explore other efficacy outcome measures of two concentrations of STN1013600 ophthalmic solution (0.1% and 0.3%) twice daily when compared to Placebo in ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2667376224000544

An updated systematic review of pharmacological ... Another drug – STN1013600 ophthalmic solution (ursodeoxycholic acid) was evaluated for the effectiveness and safety in phase IIa clinical trial (NCT05665387) ...

4. trial.medpath.com trial.medpath.com/clinical-trial/fb5b1db5a69e2176/nct05665387-opsis-stn1013600-presbyopia

Study Assessing the Efficacy and Safety of STN1013600 ... This is a Phase IIa study to assess efficacy and safety of STN1013600 ophthalmic solution (0.1%, and 0.3 %), twice daily when compared to Placebo...

5. withpower.com withpower.com/trial/phase-2-presbyopia-11-2022-f3c99

Study Assessing the Efficacy and Safety of STN1013600 ... The research on lifitegrast ophthalmic solution, which is similar to STN1013600, shows it is effective in treating dry eye disease compared to a placebo. This ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11541684/

An updated systematic review of pharmacological treatments ... Another drug – STN1013600 ophthalmic solution (ursodeoxycholic acid) was evaluated for the effectiveness and safety in phase IIa clinical trial ...

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/87/NCT05665387/Prot_000.pdf

Study Protocol Cover Page Safety of STN1013600 will be assessed by adverse events (AEs),. Intra-ocular Pressure (IOP), slit-lamp bio-microscopy, ophthalmoscopy, and ...