A Phase 2 interventional study of SUN-131 1.5% TDS and Placebo TDS in Chalazion, sponsored by Senju USA, Inc.. Completed at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-11.
Sponsored by Senju USA, Inc. · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy and safety of SUN-131 1.5% TDS as compared with placebo TDS in the treatment of chalazion based on the proportion of subjects that have complete response. Complete response is defined as the absence of any significant clinical signs of a chalazion with possible scaring or skin defects resulting from healing of the chalazion allowed.
Subjects will be randomly assigned to receive one of the following treatments in the affected eyelid:
At baseline prior to application of the TDS an assessment will be performed on both the subject's eyes including the chalazion site itself.
All subjects will return to the site on Days 8±1, 15±2 and 23±2 for evaluations. During the the 23±2 visit, a clinical evaluation will be performed to determine if the chalazion is still present.
There will also be follow up on Day 29±3, and on Day 50 visit (study days 47 to 60) to evaluate the safety and durability of the effect of the SUN-131 1.5% TDS.
Data review and safety assessments will be conducted by the medical monitor periodically throughout the trial and at the conclusion of the study.
Senju USA, Inc. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will be randomly assigned to receive SUN-131 1.5% TDS for the affected eye. All patches will be worn for 16±4 hours each day for 21 days.
Drug: SUN-131 1.5% TDS
Placebo Patch for Blinding Purposes
Drug: Placebo TDS
Active transdermal patch
Placebo transdermal patch for blinding
Complete Response
Complete response is defined as the absence of any significant clinical signs of a chalazion with possible scaring or skin defects resulting from healing of the chalazion allowed.
Time frame: Day 23±2
Change in Chalazion Size
Size of the chalazion will be assessed using a caliper and measured as height and width in mm.
Time frame: Study days 47 to 60
Change in Chalazion Erythema
Erythema of the chalazion site itself will be assessed using a 5-point scale (i.e. 0 = no signs of erythema; to 4 = severe erythema)
Time frame: Study days 47 to 60
Pain Associated with the Chalazion
Pain assessments will be done at the clinical site using a 100 mm visual analog scale.
Time frame: Study days 47 to 60
Time to Complete Response of the Target Chalazion
Time frame: Study days 47 to 60
Durability of Response
Clinical assessment of the presence of a chalazion if there was a complete response by Day 23±2.
Time frame: Study days 47 to 60
Comparison of Adverse Event Rates and Skin Irritation between Treatment Arms
Time frame: Day 23±2
The record gives a start of Oct 2014, a primary completion of Jan 2016 and a completion of Jan 2016. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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Chalazion
Senju USA, Inc.