Trial Outcomes & Findings for Clobetasol Propionate Ophthalmic Nanoemulsion 0.05% for the Treatment of Inflammation and Pain Associated With Cataract Surgery (CLOSE-1) (NCT NCT04246801)

NCT ID: NCT04246801

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: 250 participants
• Primary outcome timeframe: Day 8
• Results posted on: 2022-12-22

Participant Flow

Patient 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	140	71
Overall Study COMPLETED	135	65
Overall Study NOT COMPLETED	5	6

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	1
Overall Study Lack of Efficacy	0	2
Overall Study Lost to Follow-up	1	1
Overall Study Withdrawal by Subject	2	1

Baseline Characteristics

Clobetasol Propionate Ophthalmic Nanoemulsion 0.05% for the Treatment of Inflammation and Pain Associated With Cataract Surgery (CLOSE-1)

Baseline characteristics by cohort

Measure	Clobetasol Propionate n=140 Participants Investigational treatment 1 drop four times a day	Placebo n=71 Participants Vehicle 1 drop four times a day	Total n=211 Participants Total of all reporting groups
Age, Continuous	67.7 years STANDARD_DEVIATION 8.6 • n=93 Participants	65.5 years STANDARD_DEVIATION 7.7 • n=4 Participants	67.0 years STANDARD_DEVIATION 8.3 • n=27 Participants
Sex: Female, Male Female	77 Participants n=93 Participants	38 Participants n=4 Participants	115 Participants n=27 Participants
Sex: Female, Male Male	63 Participants n=93 Participants	33 Participants n=4 Participants	96 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Asian	5 Participants n=93 Participants	6 Participants n=4 Participants	11 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	25 Participants n=93 Participants	7 Participants n=4 Participants	32 Participants n=27 Participants
Race (NIH/OMB) White	109 Participants n=93 Participants	58 Participants n=4 Participants	167 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	140 participants n=93 Participants	71 participants n=4 Participants	211 participants n=27 Participants

PRIMARY outcome

Timeframe: Day 8

Population: FAS Population with anterior chamber cell grade assessment 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=67 Participants Vehicle 1 drop four times a day
Anterior Chamber Cell Grade	67 Participants	18 Participants

SECONDARY outcome

Timeframe: Day 8

Population: FAS Population with pain VAS assessment at Day 8

Percentage of participants with VAS pain score of "0" (no eye pain). Pain was scored by ticking on a continuous scale comprised of a 10 cm horizontal line anchored by two verbal descriptions: "no eye pain" (score of 0) and "worst imaginable eye pain" (score of 10).

Outcome measures

Measure	Clobetasol Propionate n=137 Participants Investigational treatment 1 drop four times a day	Placebo n=66 Participants Vehicle 1 drop four times a day
Pain Visual Analogue Scale (VAS) Score	83 Participants	19 Participants

Adverse Events

Clobetasol Propionate

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Clobetasol Propionate n=140 participants at risk Investigational treatment 1 drop four times a day	Placebo n=71 participants at risk Vehicle 1 drop four times a day
Eye disorders Cystoid Macular oedema	0.71% 1/140 • Number of events 1 • Overall study period (4 weeks)	0.00% 0/71 • Overall study period (4 weeks)

Other adverse events

Measure	Clobetasol Propionate n=140 participants at risk Investigational treatment 1 drop four times a day	Placebo n=71 participants at risk Vehicle 1 drop four times a day
Eye disorders Eye Pain	0.00% 0/140 • Overall study period (4 weeks)	4.2% 3/71 • Number of events 3 • Overall study period (4 weeks)
Eye disorders Lacrimation increased	0.71% 1/140 • Number of events 1 • Overall study period (4 weeks)	2.8% 2/71 • Number of events 2 • Overall study period (4 weeks)
Endocrine disorders Photophobia	0.00% 0/140 • Overall study period (4 weeks)	4.2% 3/71 • Number of events 3 • 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