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New treatment option for Non-infectious Anterior Uveitis
Official title Tacrolimus Ophthalmic Solution for the Treatment of Non-infectious Anterior Uveitis
ClinicalTrials.gov ID: NCT07285070
What this study is testing
What is Tacrolimus ophthalmic solution?
Tacrolimus ophthalmic solution is an investigational medicine, being studied as a potential treatment for non-infectious anterior uveitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The primary objective of the study is to investigate the safety and tolerability of NOV05 eye drops at two concentrations QID in patients with active non-infectious anterior uveitis.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 6 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Be ≥18 years of age;
- Provide written informed consent;
- Be diagnosed with active non-infectious anterior uveitis requiring initiation or increase of topical steroids administration for the management of...
- Have an onset of symptoms within 4 weeks;
You likely can't join if
- Have severe/serious ocular pathology in the study eye which may preclude study completion or interferes with trial assessment, in the judgement of...
- Have a history of or a current ocular or periocular malignancy;
- Have active intermediate or posterior uveitis in the study eye or another documented posterior segment inflammation;
- A confirmed or highly suspicious infectious uveitis eg, CMV, Herpes simplex, Herpes zoster, syphilis, tuberculosis, lyme disease;
- Have a known allergy or sensitivity to the IMP tacrolimus or semifluorinated alkanes (SFA);
- Be a woman who is pregnant, nursing, or planning a pregnancy;
See the full eligibility criteria
- Be ≥18 years of age;
- Provide written informed consent;
- Be diagnosed with active non-infectious anterior uveitis requiring initiation or increase of topical steroids administration for the management of ocular inflammation;
- Have an onset of symptoms within 4 weeks;
- Have severe/serious ocular pathology in the study eye which may preclude study completion or interferes with trial assessment, in the judgement of the clinical Investigator;
- Have a history of or a current ocular or periocular malignancy;
- Have active intermediate or posterior uveitis in the study eye or another documented posterior segment inflammation;
- A confirmed or highly suspicious infectious uveitis eg, CMV, Herpes simplex, Herpes zoster, syphilis, tuberculosis, lyme disease;
- Have a known allergy or sensitivity to the IMP tacrolimus or semifluorinated alkanes (SFA);
- Be a woman who is pregnant, nursing, or planning a pregnancy;
- Have a condition or be in a situation (e.g. language barrier, non-cooperative, history of substance abuse) which the Investigator considers that it may put the patient at significant risk, may confound the trial...
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
- Waltham, Massachusetts, United States
- Palisades Park, New Jersey, United States
- McAllen, Texas, United States
- Norfolk, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States; Waltham, Massachusetts, United States; Palisades Park, New Jersey, United States; McAllen, Texas, United States; Norfolk, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.