Trial Outcomes & Findings for Clobetasol Propionate Ophthalmic Nanoemulsion 0.05% for the Treatment of Inflammation and Pain Associated With Cataract Surgery (CLOSE-2) (NCT NCT04249076)

NCT ID: NCT04249076

Last Updated: 2022-12-22

Results Overview

Percentage of participants with anterior chamber cell grade of "0" (absence of cells)

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 215 participants
• Primary outcome timeframe: Day 8
• Results posted on: 2022-12-22

Participant Flow

Patients with routine unilateral cataract surgery on the day prior to study randomization.

Patients with at least 5 cells in anterior chamber on the first day after surgery (at Visit 1)

Participant milestones

Measure	Clobetasol Propionate Investigational treatment 1 drop four times a day	Placebo Vehicle 1 drop four times a day
Overall Study STARTED	141	74
Overall Study COMPLETED	139	69
Overall Study NOT COMPLETED	2	5

Reasons for withdrawal

Measure	Clobetasol Propionate Investigational treatment 1 drop four times a day	Placebo Vehicle 1 drop four times a day
Overall Study Adverse Event	1	1
Overall Study Protocol Violation	1	2
Overall Study Lack of Efficacy	0	1
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Clobetasol Propionate Ophthalmic Nanoemulsion 0.05% for the Treatment of Inflammation and Pain Associated With Cataract Surgery (CLOSE-2)

Baseline characteristics by cohort

Measure	Clobetasol Propionate n=141 Participants Investigational treatment 1 drop four times a day	Placebo n=74 Participants Vehicle 1 drop four times a day	Total n=215 Participants Total of all reporting groups
Age, Continuous	68.1 years STANDARD_DEVIATION 8.2 • n=5 Participants	67.5 years STANDARD_DEVIATION 9.2 • n=7 Participants	67.9 years STANDARD_DEVIATION 8.5 • n=5 Participants
Sex: Female, Male Female	76 Participants n=5 Participants	45 Participants n=7 Participants	121 Participants n=5 Participants
Sex: Female, Male Male	65 Participants n=5 Participants	29 Participants n=7 Participants	94 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	21 Participants n=5 Participants	14 Participants n=7 Participants	35 Participants n=5 Participants
Race (NIH/OMB) White	104 Participants n=5 Participants	52 Participants n=7 Participants	156 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	13 Participants n=5 Participants	6 Participants n=7 Participants	19 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 8

Population: FAS Population at Day 8

Percentage of participants with anterior chamber cell grade of "0" (absence of cells)

Outcome measures

Measure	Clobetasol Propionate n=139 Participants Investigational treatment 1 drop four times a day	Placebo n=71 Participants Vehicle 1 drop four times a day
Anterior Chamber Cell Grade	38 Participants	7 Participants

SECONDARY outcome

Timeframe: Day 8

Population: FAS Population at Day 8

Percentage of participants with VAS pain score of "0" (no eye pain)

Outcome measures

Measure	Clobetasol Propionate n=139 Participants Investigational treatment 1 drop four times a day	Placebo n=71 Participants Vehicle 1 drop four times a day
Pain Visual Analogue Scale (VAS) Score	68 Participants	31 Participants

Adverse Events

Clobetasol Propionate

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Clobetasol Propionate n=141 participants at risk Interventional treatment 1 drop four times a day	Placebo n=74 participants at risk Vehicle 1 drop four times a day
Ear and labyrinth disorders Vertigo positional	0.00% 0/141 • Overall study period (4 weeks)	1.4% 1/74 • Number of events 1 • Overall study period (4 weeks)
Eye disorders Cystoid Macular oedema	0.71% 1/141 • Number of events 1 • Overall study period (4 weeks)	0.00% 0/74 • Overall study period (4 weeks)
Gastrointestinal disorders Vomiting	0.00% 0/141 • Overall study period (4 weeks)	1.4% 1/74 • Number of events 1 • Overall study period (4 weeks)
Nervous system disorders Dizziness	0.00% 0/141 • Overall study period (4 weeks)	1.4% 1/74 • Number of events 1 • Overall study period (4 weeks)

Other adverse events

Measure	Clobetasol Propionate n=141 participants at risk Interventional treatment 1 drop four times a day	Placebo n=74 participants at risk Vehicle 1 drop four times a day
Eye disorders Corneal oedema	1.4% 2/141 • Number of events 2 • Overall study period (4 weeks)	2.7% 2/74 • Number of events 2 • Overall study period (4 weeks)
Eye disorders Eye inflammation	0.00% 0/141 • Overall study period (4 weeks)	6.8% 5/74 • Number of events 5 • Overall study period (4 weeks)

Additional Information

Medical Director

Laboratorios Salvat, S.A

Phone: +34933946400

Email: ejimenez@svt.com

Results disclosure agreements

• Principal investigator is a sponsor employee Any publication shall be expressly authorized in written by the Sponsor
• Publication restrictions are in place

Restriction type: OTHER