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NCT04246801 · ClinicalTrials.gov registry record · Phase 3
Clobetasol Propionate Ophthalmic Nanoemulsion 0.05% for the Treatment of Inflammation and Pain Associated With Cataract Surgery (CLOSE-1)
A Phase 3 study, sponsored by Salvat.
- Completed
- Registry status
- Phase 3
- Development phase
- 250
- Enrollment target
NCT04246801 is a Phase 3 study that has completed, run by Salvat. The registered enrollment target is 250 participants.
The verdict
NCT04246801, a Phase 3 study, has completed, sponsored by Salvat.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 250 participants
- Enrollment target
Study Summary
Cataract surgery is one of the most common surgical procedures performed worldwide. In fact, in 2017, 3.8 million cataracts procedures were performed in the US. Despite of surgical advances, pain and inflammation after ophthalmic surgery continues to be a burden on both patients and physicians. The treatment of postoperative pain is essential for hospitalized patients, but it is even more important for patients who are treated on an outpatient basis. This study will compare the efficacy and safety of clobetasol propionate ophthalmic nanoemulsion 0.05% to placebo, when administering one drop four times a day during 14 days after routine unilateral cataract surgery. Participants will undergo routine cataract surgery according to the ophthalmologist's normal procedures. Overall, 210 participants are planned to take part in the study. They will be screened across 20 centers in the US. Participants who experience postoperative inflammation on the first day following routine cataract surgery and who meet all other eligibility criteria will be randomly assigned by chance to one of two study groups in a 2:1 ratio to receive either clobetasol propionate ophthalmic nanoemulsion 0.05 % (N=140) or placebo (N=70) for the treatment of inflammation and pain associated with cataract surgery. Six (6) study visits are planned: Visit -1 (Screening), Visit 1 (Baseline; 24h after the surgery), Visit 2 (Day 3), Visit 3 (Day 8), Visit 4 (Day 15), and Visit 5 (Day 29). The ophthalmologist will administer the first dose of the study medication 24 hours after the surgery, at the end of the Baseline visit, at the study center. Study medication will be then dispensed to participants for self-administration during the study at a dosage of one drop four times a day, during 14 days. Direct instillation is the most efficient method for delivery to the ocular surface and is an accepted and widely used method for topical application to the eye. This study will examine effect and tolerability f
Interventions
- DRUG Vehicle
- DRUG Clobetasol propionate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2020-06-10 |
| Est. Completion | 2021-05-19 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04246801
The ClinicalTrials.gov registry entry for NCT04246801 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Salvat, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Vehicle is the first listed.
NCT04246801 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04246801 about?
NCT04246801 is a clinical study titled "Clobetasol Propionate Ophthalmic Nanoemulsion 0.05% for the Treatment of Inflammation and Pain Associated With Cataract Surgery (CLOSE-1)". Cataract surgery is one of the most common surgical procedures performed worldwide. In fact, in 2017, 3.8 million cataracts procedures were performed in the US. Despite of surgical advances, pain and inflammation after ophthalmic surgery continues to be a burden on both patients and physicians. The...
What is the current status of trial NCT04246801?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 250 participants. The study started on 2020-06-10. Estimated completion is 2021-05-19.
What interventions are being tested in trial NCT04246801?
The interventions under investigation include: Vehicle (DRUG), Clobetasol propionate (DRUG).
Who is sponsoring clinical trial NCT04246801?
This trial is sponsored by Salvat, which has 3 total clinical trials registered on ClinicalTrials.gov.
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