Conditions: Cataract
Keywords: Cataract surgery Inflammation Pain Clobetasol propionate Ophthalmology
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 250
Healthy volunteers: no

Brief 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 for 14 days of clobetasol propionate ophthalmic nanoemulsion 0.05% dosed four times a day.

This study is being conducted to support an application for approval to market clobetasol propionate ophthalmic nanoemulsion 0.05% in the US for the indication of inflammation and pain after ocular surgery. The reference (comparator) product in this study, the vehicle, is expected to provide a lower efficacy rate when compared to clobetasol 0.05%.

Detailed description:

Arms:
arm 1: Clobetasol propionate (Clobetasol propionate ophthalmic nanoemulsion 0.05%)

First dose of the drug will be dispensed at the end of the Baseline visit at the study center. Then, study medication will be dispensed to the participant for self-administration at a dosage of one drop four (4) times a day during 14 days. arm 2: First dose of the drug will be dispensed at the end of the Baseline visit at the study center. Then, study medication will be dispensed to the participant for self-administration at a dosage of one drop four (4) times a day during 14 days.

Interventions: intervention 1: Clobetasol propionate intervention 2: Vehicle
Intervention descriptions: intervention 1: Clobetasol propionate ophthalmic nanoemulsion 0.05%, is an oil-in-water (o/w), clear or slightly yellowish nanoemulsion containing the active ingredient clobetasol propionate at a concentration of 0.05% weight per weight (w/w) intervention 2: Vehicle is identical in appearance and composition to clobetasol propionate ophthalmic nanoemulsion 0.05% but, without the active substance

Protocol document:
Prot_000.pdf: 
 
 
 










 
 
 
 
 
 
 
 








 
































 
 
 
 
 
 


 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
 
 
 
 
 
 
 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
 
 
 
 
 
 
 


- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
 
 
 
 
 
 
 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 


- 
- 
 
 
 
 
 
 
 
- 
- 
- 
- 
- 
- 
- 
- 
 
 
 
 
 
 
 
- 
- 
- 
- 
- 
- 
- 
- 


- 
- 
 
 
 
 
 
 
 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
 
 
 
 
 
 
 
- 
- 
- 
- 


- 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
 
 
 
 
 
 
 
 






























 
 
 
 
 


- 
- 
- 
- 
- 








 
 
 
 
 


- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
 
 
 
 
 
 
 
- 
- 
- 
- 


- 
- 
- 
- 
- 
- 
- 
- 
 
 
 
 
 
 
 
- 
- 
- 
- 
- 
- 
- 
 
- 
- 


- 
- 
- 
- 
- 
 
 
 
 
 
 
 
- 
- 
- 
- 
- 
- 
- 
- 
- 
 
 
 
 
 
 
 
- 
- 


- 
- 
- 
- 
- 
- 
- 
- 
 
 
 
 
 
 
 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 


- 
- 
 
 
 
 
 
 
 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
 
 


 
 
 
 
 
- 
- 
- 
- 
- 
- 
- 


 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
 
 
 
 
 
 


 
 
 
 
 




 
 




 
 


 
 
 




 
 
 
 
 
 
 
 
 
 
 
 


 
 
 
 
 
 
 
 
 
 


 
 
 
 
 
 
 
 
 
 
 
 
 




 
 
 
 
- 
- 
- 


 


 
 
 
 
 


 
 
 
 
 
 
 
 
 
 
 




 
 
 
 
 
 
 


 
 
 
 
 
 
 
 


 
 




- 
- 
- 


- 
- 
 
 




 
 




 
 


 
 
 
 
 
 
 
 
 
 


 
 
 
 
 
























- 
- 
 


- 
- 
- 
- 
- 


- 


 
1. 
2. 
3. 
4. 
5. 
6. 
 
 
 
 
7. 
8. 




 
Please assess the severity of the eye discomfort by using the following scale. 
 



SAP_001.pdf: