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NCT04249076 · ClinicalTrials.gov registry record · Phase 3
Clobetasol Propionate Ophthalmic Nanoemulsion 0.05% for the Treatment of Inflammation and Pain Associated With Cataract Surgery (CLOSE-2)
A Phase 3 study of Cataract, sponsored by Salvat.
- Completed
- Registry status
- Phase 3
- Development phase
- 215
- Enrollment target
- 18
- Study locations
NCT04249076 is a Phase 3 study of Cataract that has completed, run by Salvat. The registered enrollment target is 215 participants, roughly in line with the 226-participant average among 83 other Cataract trials with a reported enrollment target. The trial reports 18 study locations across 10 states.
The verdict
NCT04249076, a Phase 3 study of Cataract, has completed, sponsored by Salvat.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 215 participants
- Enrollment target
- 18
- Study locations
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 patients 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 for 1
Conditions Studied
Interventions
- DRUG Vehicle
- DRUG Clobetasol Propionate
Study Locations (18)
California
- Inland Eye Specialists - Hemet
- United Medical Research Institute - Inglewood
- Visionary Eye Institute - Newport Beach
- North Bay Eye - Petaluma
Florida
- Levenson Eye Associates - Jacksonville
- International Eye Associates, PA - Ormond Beach
- Andrew Gardner Logan dba Ophthalmic Research LLC - Tamarac
Texas
- Houston Eye Associates - Houston
- Shah Eye Center - Mission
- Braverman-Terry-Oei Eye Associates - San Antonio
Missouri
- Ophalmology Associates - St Louis
- Comprehensive Eye Care Ltd - Washington
Arizona
- Walman Eye Center - Sun City
Georgia
- Eye Consultants of Atlanta - Atlanta
Kansas
- Kannarr Eye Care - Pittsburg
Nevada
- NV Eyey Surgery - Henderson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 215 participants |
| Start Date | 2020-06-04 |
| Est. Completion | 2021-04-14 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04249076
The ClinicalTrials.gov registry entry for NCT04249076 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 215 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 226-participant average among 83 other Cataract trials with a reported enrollment target. The listed sponsor is Salvat, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Cataract appearing as the primary indexed condition, and to 2 interventions - of which Vehicle is the first listed.
NCT04249076 reports 18 study locations spanning 10 distinct geographic areas - top geographies include California, Florida, Texas.
Frequently Asked Questions
What is clinical trial NCT04249076 about?
NCT04249076 is a clinical study titled "Clobetasol Propionate Ophthalmic Nanoemulsion 0.05% for the Treatment of Inflammation and Pain Associated With Cataract Surgery (CLOSE-2)". 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 NCT04249076?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 215 participants. The study started on 2020-06-04. Estimated completion is 2021-04-14.
What conditions does trial NCT04249076 study?
This clinical trial studies the following conditions: Cataract.
What interventions are being tested in trial NCT04249076?
The interventions under investigation include: Vehicle (DRUG), Clobetasol Propionate (DRUG).
Who is sponsoring clinical trial NCT04249076?
This trial is sponsored by Salvat, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04249076 being conducted?
This trial has 18 study locations across Arizona, California, Florida, Georgia, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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