NCT04130802Phase 2Completed

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

Study sponsor: Oculis

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2020-01-31Actual

Enrollment · participants153Actual

Source updated2025-09-10Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Inflammation Corneal; Pain, Postoperative

Treatments or interventions studied

OCS-01 - Dexamethasone Cyclodextrin Nanoparticle Ophthalmic Suspension 1.5% mg/mLDrugAlso known as DexNP
PlaceboDrugAlso known as Vehicle

Primary outcomes · main study measures

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measure: Number of Subjects With Absence of Anterior Chamber Cells (i.e. Score of '0'); description: 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; timeFrame: at Day 15 (visit 6); measure: Number of Subjects With Absence of Ocular Pain (i.e. Score of '0'); description: 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.; timeFrame: at Day 4 (visit 4)

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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