A Study to Assess the Safety and Effectiveness of SJP-0035 for the Treatment of Patients With Dry… (NCT03527212) | Clinical Trial Compass
CompletedPhase 3
A Study to Assess the Safety and Effectiveness of SJP-0035 for the Treatment of Patients With Dry Eye Disease
United States329 participantsStarted 2018-08-20
Plain-language summary
A double-masked, randomized, multi-center, placebo-controlled, parallel-group study in adult patients with Dry Eye Disease (DED). Patients will be randomly assigned to receive either SJP-0035 0.001% or placebo
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Signed informed consent form (ICF).
* Has Dry Eye Disease (DED) with moderate to severe corneal fluorescein staining in both eyes.
* Has blurred vision caused by DED in both eyes.
* Women of childbearing potential must have negative serum pregnancy test results at Screening and Randomization and agree to use effective contraception throughout the study; post-menopausal women must have negative serum pregnancy test results at Screening and Randomization.
* Male participants must agree to use an acceptable form of contraception (i.e. a condom plus spermicide) and to refrain from sperm donation throughout the study.
Exclusion Criteria:
* Has any corneal stromal or endothelial abnormalities in either eye.
* Has any active or chronic allergic, bacterial or viral infection of ocular adnexa and eye structures in either eye.
* Has had eye surgery (including cataract, vitreous or eyelid surgery) in either eye within the last 28 days prior to first dose of study drug.
* Has had refractive surgery (including eye surface laser surgery) in either eye within the last 180 days prior to first dose of study drug.
* Has used any eye medication in either eye within 14 days prior to first dose of study drug, or is anticipated to require such medications during the study. Preservative-free artificial tears may be used up to 72 hours prior to the first dose in either eye.
* Is a contact lens wearer and cannot discontinue use in both eyes from Screening through the duration…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.