Trial Outcomes & Findings for OCS-01 in Treating Inflammation and Pain in Post-cataract Patients (NCT NCT04130802)

Last Updated: 2025-09-10

Results Overview

Absence of anterior chamber cells as measured by slit beam with fluorescein. The anterior chamber cell count was recorded as the actual number of cells observed if ≤10 cells were seen, otherwise a range was reported. The observed anterior chamber cell count at Visit 6 was used and categorized for analysis as follows: * Absence of anterior chamber cells: anterior chamber cell count of 0 / Grade 0 * Presence of anterior chamber cells: anterior chamber cell count of 1 or more / Grade 1, 2, 3, or 4

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

153 participants

Primary outcome timeframe

at Day 15 (visit 6)

Results posted on

2025-09-10

Participant Flow

Participant milestones

Participant milestones
Measure	OCS-01 1.5% mg/mL QD eye drops OCS-01 - Dexamethasone Cyclodextrin Nanoparticle Ophthalmic Suspension 1.5% mg/mL: OCS-01 eye drops Placebo: Vehicle eye drops	OCS-01 1.5% mg/mL BID eye drops OCS-01 - Dexamethasone Cyclodextrin Nanoparticle Ophthalmic Suspension 1.5% mg/mL: OCS-01 eye drops	Placebo (Vehicle) BID eye drops Placebo: Vehicle eye drops
Overall Study STARTED	51	51	51
Overall Study COMPLETED	50	50	48
Overall Study NOT COMPLETED	1	1	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

OCS-01 in Treating Inflammation and Pain in Post-cataract Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OCS-01 1.5% mg/mL QD n=51 Participants eye drops OCS-01 - Dexamethasone Cyclodextrin Nanoparticle Ophthalmic Suspension 1.5% mg/mL: OCS-01 eye drops Placebo: Vehicle eye drops	OCS-01 1.5% mg/mL BID n=51 Participants eye drops OCS-01 - Dexamethasone Cyclodextrin Nanoparticle Ophthalmic Suspension 1.5% mg/mL: OCS-01 eye drops	Placebo (Vehicle) BID n=51 Participants eye drops Placebo: Vehicle eye drops	Total n=153 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	22 Participants n=7 Participants	15 Participants n=5 Participants	50 Participants n=4 Participants
Age, Categorical >=65 years	38 Participants n=5 Participants	29 Participants n=7 Participants	36 Participants n=5 Participants	103 Participants n=4 Participants
Age, Continuous	68.0 years STANDARD_DEVIATION 6.86 • n=5 Participants	65.8 years STANDARD_DEVIATION 6.59 • n=7 Participants	67.5 years STANDARD_DEVIATION 8.41 • n=5 Participants	67.1 years STANDARD_DEVIATION 7.34 • n=4 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	36 Participants n=7 Participants	32 Participants n=5 Participants	101 Participants n=4 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	15 Participants n=7 Participants	19 Participants n=5 Participants	52 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	8 Participants n=7 Participants	4 Participants n=5 Participants	15 Participants n=4 Participants
Race (NIH/OMB) White	47 Participants n=5 Participants	42 Participants n=7 Participants	47 Participants n=5 Participants	136 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	51 participants n=5 Participants	51 participants n=7 Participants	51 participants n=5 Participants	153 participants n=4 Participants

PRIMARY outcome

Timeframe: at Day 15 (visit 6)

Outcome measures

Outcome measures
Measure	OCS-01 1.5% mg/mL QD n=51 Participants eye drops OCS-01 - Dexamethasone Cyclodextrin Nanoparticle Ophthalmic Suspension 1.5% mg/mL: OCS-01 eye drops	OCS-01 1.5% mg/mL BID n=51 Participants eye drops OCS-01 - Dexamethasone Cyclodextrin Nanoparticle Ophthalmic Suspension 1.5% mg/mL: OCS-01 eye drops	Placebo (Vehicle) BID n=51 Participants eye drops Placebo: Vehicle eye drops
Number of Subjects With Absence of Anterior Chamber Cells (i.e. Score of '0')	26 participants	34 participants	10 participants

PRIMARY outcome

Timeframe: at Day 4 (visit 4)

Absence of pain as assessed by Ocular Pain Grading Scale (Min 0, Max 10) in which 0 is no pain and 10 is the worst possible. Ocular pain was assessed by the patient at screening and at each follow-up visit, utilizing a numerical pain rating scale. Scores ranged from 0 to 10, where 0 = No Pain and 10 = Severe Pain, such that larger scores corresponded to higher levels of pain.

Outcome measures

Outcome measures
Measure	OCS-01 1.5% mg/mL QD n=51 Participants eye drops OCS-01 - Dexamethasone Cyclodextrin Nanoparticle Ophthalmic Suspension 1.5% mg/mL: OCS-01 eye drops	OCS-01 1.5% mg/mL BID n=51 Participants eye drops OCS-01 - Dexamethasone Cyclodextrin Nanoparticle Ophthalmic Suspension 1.5% mg/mL: OCS-01 eye drops	Placebo (Vehicle) BID n=51 Participants eye drops Placebo: Vehicle eye drops
Number of Subjects With Absence of Ocular Pain (i.e. Score of '0')	37 participants	32 participants	23 participants

Adverse Events

OCS-01 1.5% mg/mL QD

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

OCS-01 1.5% mg/mL BID

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Placebo (Vehicle) BID

Serious events: 1 serious events

Other events: 20 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	OCS-01 1.5% mg/mL QD n=51 participants at risk eye drops OCS-01 - Dexamethasone Cyclodextrin Nanoparticle Ophthalmic Suspension 1.5% mg/mL: OCS-01 eye drops	OCS-01 1.5% mg/mL BID n=51 participants at risk eye drops OCS-01 - Dexamethasone Cyclodextrin Nanoparticle Ophthalmic Suspension 1.5% mg/mL: OCS-01 eye drops	Placebo (Vehicle) BID n=51 participants at risk eye drops Placebo: Vehicle eye drops
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/51 • The AEs were queried at visit 2 (Day 1, 18 - 30h post surgery), visit 4 (Day 4) , visit 5 (Day 8), visit 6 (Day 15) & visit 7 (Day 22)	0.00% 0/51 • The AEs were queried at visit 2 (Day 1, 18 - 30h post surgery), visit 4 (Day 4) , visit 5 (Day 8), visit 6 (Day 15) & visit 7 (Day 22)	2.0% 1/51 • Number of events 1 • The AEs were queried at visit 2 (Day 1, 18 - 30h post surgery), visit 4 (Day 4) , visit 5 (Day 8), visit 6 (Day 15) & visit 7 (Day 22)
Eye disorders noninfectious endophthamitis	0.00% 0/51 • The AEs were queried at visit 2 (Day 1, 18 - 30h post surgery), visit 4 (Day 4) , visit 5 (Day 8), visit 6 (Day 15) & visit 7 (Day 22)	2.0% 1/51 • Number of events 1 • The AEs were queried at visit 2 (Day 1, 18 - 30h post surgery), visit 4 (Day 4) , visit 5 (Day 8), visit 6 (Day 15) & visit 7 (Day 22)	0.00% 0/51 • The AEs were queried at visit 2 (Day 1, 18 - 30h post surgery), visit 4 (Day 4) , visit 5 (Day 8), visit 6 (Day 15) & visit 7 (Day 22)
Blood and lymphatic system disorders Anemia	0.00% 0/51 • The AEs were queried at visit 2 (Day 1, 18 - 30h post surgery), visit 4 (Day 4) , visit 5 (Day 8), visit 6 (Day 15) & visit 7 (Day 22)	0.00% 0/51 • The AEs were queried at visit 2 (Day 1, 18 - 30h post surgery), visit 4 (Day 4) , visit 5 (Day 8), visit 6 (Day 15) & visit 7 (Day 22)	2.0% 1/51 • Number of events 1 • The AEs were queried at visit 2 (Day 1, 18 - 30h post surgery), visit 4 (Day 4) , visit 5 (Day 8), visit 6 (Day 15) & visit 7 (Day 22)

Other adverse events

Additional Information

Chief Development Officer

Oculis SA

Phone: 0041 21 711 39 70

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Investigator agrees not to publish/present the results until such time as the aggregate study results are published. After such time, Investigator may publish the results in accordance with the following: Investigator shall submit to Sponsor any such proposed publication/presentation resulting from or relating to the Study at least 60 days prior to the submission for publication. Sponsor may require the delay of publication/presentation for an additional period of time not to exceed 120 days.
Publication restrictions are in place

Restriction type: OTHER