Study Assessing the Efficacy and Safety of STN1013600 Ophthalmic Solution 0.1% and 0.3% Compared With Placebo in Subjects With Presbyopia
(OPSIS Trial)
Recruiting at 11 trial locations
SI
Overseen BySanten Inc Clinical Operations
Age: 18 - 65
Sex: Any
Trial Phase: Phase 2
Sponsor: Santen Inc.
Prior Safety DataThis treatment has passed at least one previous human trial
Trial Summary
What is the purpose of this trial?
This trial tests eye drops called STN1013600 in people with presbyopia to see if it helps them focus better on nearby objects. The study compares two strengths of the drops over several weeks.
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.
What data supports the effectiveness of the drug STN1013600 ophthalmic solution?
What safety data exists for STN1013600 ophthalmic solution?
How does the drug STN1013600 ophthalmic solution differ from other treatments for dry eye?
Eligibility Criteria
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
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
Treatment Details
Interventions
- Placebo
- STN1013600 ophthalmic solution
Participant Groups
3Treatment groups
Experimental Treatment
Placebo Group
Group I: 0.3% STN1013600 ophthalmic solutionExperimental Treatment1 Intervention
0.3% STN1013600 ophthalmic solution 1 drop BID
Group II: 0.1% STN1013600 ophthalmic solutionExperimental Treatment1 Intervention
0.1% STN1013600 ophthalmic solution 1 drop BID
Group III: Placebo (Vehicle) ophthalmic solutionPlacebo Group1 Intervention
Placebo (Vehicle) ophthalmic solution BID
Find a Clinic Near You
Who Is Running the Clinical Trial?
Santen Inc.
Lead Sponsor
Trials
35
Recruited
4,600+
Findings from Research
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]
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]
References
Phase II placebo-controlled study of nepafenac ophthalmic suspension 0.1% for postoperative inflammation and ocular pain associated with cataract surgery in Japanese patients. [2021]
Bilateral Effect of OC-01 (Varenicline Solution) Nasal Spray for Treatment of Signs and Symptoms in Individuals with Mild, Moderate, and Severe Dry Eye Disease. [2023]
Lifitegrast ophthalmic solution 5.0% for treatment of dry eye disease: results of the OPUS-1 phase 3 study. [2022]
Safety of Lifitegrast Ophthalmic Solution 5.0% in Patients With Dry Eye Disease: A 1-Year, Multicenter, Randomized, Placebo-Controlled Study. [2022]
Rebamipide (OPC-12759) in the treatment of dry eye: a randomized, double-masked, multicenter, placebo-controlled phase II study. [2017]
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. [2022]
Ocular comfort assessment of lifitegrast ophthalmic solution 5.0% in OPUS-3, a Phase III randomized controlled trial. [2022]
Safety and tolerability of lifitegrast ophthalmic solution 5.0%: Pooled analysis of five randomized controlled trials in dry eye disease. [2022]
[Effect on ocular blood flow of Combigan® versus placebo in patients with ocular hypertension]. [2015]
Comparison of Topical Application of TSG-6, Cyclosporine, and Prednisolone for Treating Dry Eye. [2016]
Topical TSG-6 Administration Protects the Ocular Surface in Two Mouse Models of Inflammation-Related Dry Eye. [2015]
Subconjunctival Sirolimus-Loaded Liposomes for the Treatment of Moderate-to-Severe Dry Eye Disease. [2023]
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