160 Participants Needed

VSJ-110 for Dry Eye

Recruiting at 4 trial locations
VP
Overseen ByVanda Pharmaceuticals
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Vanda Pharmaceuticals
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called VSJ-110 for individuals with dry eye, a condition where the eyes don't produce enough tears or the right quality of tears. The goal is to determine if VSJ-110 is safe and effective compared to a placebo, which contains no active ingredients. Individuals who frequently experience dry, itchy, or burning eyes might be suitable for this trial. Participants will be divided into two groups: one receiving VSJ-110 and the other receiving a placebo, to compare results. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

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

Yes, you will need to stop taking certain medications before and during the trial, as there is a washout period (time without taking certain medications) required.

Is there any evidence suggesting that VSJ-110 is likely to be safe for humans?

Previous studies have shown that patients using VSJ-110 for dry eye generally found it well-tolerated. These studies compared the treatment's safety to a placebo (a substance with no active ingredients). Although detailed information about side effects isn't provided, the progression of VSJ-110 to Phase 2 suggests that early safety tests yielded positive results. Treatments typically advance to this phase only if initial studies have shown them to be safe enough. This indicates that some side effects might exist, but they weren't serious enough to halt further testing. Consulting a doctor before joining a trial is always advisable to understand any potential risks.12345

Why do researchers think this study treatment might be promising for dry eye?

Unlike the standard treatments for dry eye, which often include artificial tears and anti-inflammatory medications, VSJ-110 offers a fresh approach. This investigational treatment is unique because it targets the underlying causes of dry eye rather than just alleviating symptoms. Researchers are excited about VSJ-110 because it potentially offers a more effective and long-lasting solution, working to improve the eye's natural tear production and overall health. If successful, this could mean fewer applications and better comfort for patients suffering from this irritating condition.

What evidence suggests that VSJ-110 might be an effective treatment for dry eye?

Research shows that VSJ-110 is under study as a treatment for dry eye in this trial. Participants will receive either the VSJ-110 Solution or a Placebo Solution. Medications like VSJ-110 have a 56% chance of progressing from early research to approval for use. This drug aims to alleviate common dry eye symptoms, such as dryness and irritation. Although specific data on VSJ-110's effectiveness is still being collected, its development targets these symptoms, suggesting potential benefits for those with dry eye.12346

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have dry eye syndrome. Participants must be able to follow instructions, attend all study visits, and sign consent forms. They cannot use certain medications during the study.

Inclusion Criteria

Provide written informed consent and sign the HIPAA form
Be willing and able to follow all instructions and attend all study visits
I am 18 years old or older.

Exclusion Criteria

I am not taking any medications that are not allowed in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive VSJ-110 or placebo for the treatment of dry eye

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • VSJ-110
Trial Overview The trial is testing VSJ-110 against a placebo to see if it's safe and effective in treating dry eye. It lasts eight weeks, with patients randomly receiving either the actual drug or a placebo.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: VSJ-110 SolutionExperimental Treatment1 Intervention
Group II: Placebo SolutionPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vanda Pharmaceuticals

Lead Sponsor

Trials
68
Recruited
19,900+

Citations

VSJ-110 by Vanda Pharmaceuticals for ...According to GlobalData, Phase II drugs for Keratoconjunctivitis Sicca (Dry Eye) have a 56% phase transition success rate (PTSR) indication ...
NCT07179055 | An Eight-Week Study to Evaluate the ...The purpose of this study is to determine the safety and efficacy of VSJ-110 compared to placebo in the treatment of dry eye. Official Title. An ...
Phase 3 Efficacy (Worse-Eye Analysis) and Long-Term Safety ...OTX-101 is approved for treatment of keratoconjunctivitis sicca (KCS). We present results of a phase 3 worse-eye efficacy analysis and 1-year safety extension.
A Study to Evaluate the Safety and Efficacy of VSJ-110 ...The purpose of this study is to determine the safety and efficacy of VSJ-110 compared to placebo in the treatment of dry eye.
Value-Based Medicine, Comparative Effectiveness, and ...In summary, 0.05% ophthalmic cyclosporine emulsion provides a 4.3% improvement in quality of life over conventional lubricant therapy for the ...
Keratoconjunctivitis Sicca (KCS)... Safety and Efficacy of VSJ-110 Ophthalmic Solution in the Treatment of Dry Eye ... Safety Data Review from Preclinical Studies and Pivotal Trials. 65, Shen ...
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