A Phase 2 interventional study of OCS-01 - Dexamethasone Cyclodextrin Nanoparticle Ophthalmic Suspension 1.5% mg/mL and Placebo in Inflammation Corneal and Pain, Postoperative, sponsored by Oculis. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-10.
Sponsored by Oculis · Phase 2, Interventional, and Treatment
The DX-216 trial is a randomized, double-masked, placebo (vehicle)-controlled study evaluating the efficacy and safety of two doses of OCS-01 compared to vehicle in the treatment of inflammation and pain following cataract surgery. The primary objective is to evaluate the efficacy and safety of OCS-01 compared to placebo and the secondary objective is to evaluate the optimal dosing frequency (once a day [QD] or twice a day [BID]).
This is a multi-center, randomized, double-masked, placebo (vehicle)-controlled study, designed to evaluate the efficacy and safety of OCS-01 ophthalmic suspension (QD versus BID) compared to placebo in treating inflammation and pain following cataract surgery. Subjects will be randomized 1:1:1 to receive OCS-01 QD, OCS-01 BID, or placebo BID. Subjects will dose 1 drop in the study eye BID for 14 days, beginning 1 day post-surgery in the operated eye. The study will last up to 24 days, including a follow-up visit at Visit 7 (Day 22 ± 2).
108 studies on the registry are indexed under Keratitis; 19 are open to participants now.
This study's enrollment of 153 is above the median of 40 across 70 interventional studies indexed under Keratitis.
Browse Keratitis studies →Oculis is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 4 (57%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
eye drops
Drug: OCS-01 - Dexamethasone Cyclodextrin Nanoparticle Ophthalmic Suspension 1.5% mg/mL · Drug: Placebo
eye drops
Drug: OCS-01 - Dexamethasone Cyclodextrin Nanoparticle Ophthalmic Suspension 1.5% mg/mL
eye drops
Drug: Placebo
OCS-01 eye drops
Also known as: DexNP
Vehicle eye drops
Also known as: Vehicle
Number of Subjects With Absence of Anterior Chamber Cells (i.e. Score of '0')
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
Time frame: at Day 15 (visit 6)
Number of Subjects With Absence of Ocular Pain (i.e. Score of '0')
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.
Time frame: at Day 4 (visit 4)
| Milestone | OCS-01 1.5% mg/mL QD | OCS-01 1.5% mg/mL BID | Placebo (Vehicle) BID |
|---|---|---|---|
| Started | 51 | 51 | 51 |
| Completed | 50 | 50 | 48 |
| Not completed | 1 | 1 | 3 |
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
| participants | OCS-01 1.5% mg/mL QD | OCS-01 1.5% mg/mL BID | Placebo (Vehicle) BID |
|---|---|---|---|
| Number of Subjects With Absence of Anterior Chamber Cells (i.e. Score of '0') | 26 | 34 | 10 |
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.
| participants | OCS-01 1.5% mg/mL QD | OCS-01 1.5% mg/mL BID | Placebo (Vehicle) BID |
|---|---|---|---|
| Number of Subjects With Absence of Ocular Pain (i.e. Score of '0') | 37 | 32 | 23 |
Collected over 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). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| OCS-01 1.5% mg/mL QD | 0/51 (0%) | 0/51 (0%) | 17/51 (33.3%) |
| OCS-01 1.5% mg/mL BID | 0/51 (0%) | 1/51 (2%) | 10/51 (19.6%) |
| Placebo (Vehicle) BID | 1/51 (2%) | 1/51 (2%) | 20/51 (39.2%) |
| Event | OCS-01 1.5% mg/mL QD | OCS-01 1.5% mg/mL BID | Placebo (Vehicle) BID |
|---|---|---|---|
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 0/51 | 0/51 | 1/51 |
| noninfectious endophthamitisEye disorders | 0/51 | 1/51 | 0/51 |
| AnemiaBlood and lymphatic system disorders | 0/51 | 0/51 | 1/51 |
| Event | OCS-01 1.5% mg/mL QD | OCS-01 1.5% mg/mL BID | Placebo (Vehicle) BID |
|---|---|---|---|
| conjunctival hyperaemiaEye disorders | 3/51 | 2/51 | 8/51 |
| corneal edemaEye disorders | 5/51 | 1/51 | 8/51 |
| eye painEye disorders | 0/51 | 0/51 | 4/51 |
| anteror chamber inflammationEye disorders | 1/51 | 3/51 | 0/51 |
| iritisEye disorders | 3/51 | 0/51 | 2/51 |
| vitreous detachmentEye disorders | 2/51 | 1/51 | 0/51 |
| posterior capsule opacificationEye disorders | 2/51 | 0/51 | 0/51 |
| eye inflammationEye disorders | 1/51 | 0/51 | 2/51 |
| visual acuity reducedEye disorders | 0/51 | 0/51 | 2/51 |
| foreign body sensation in eyesEye disorders | 1/51 | 1/51 | 1/51 |
| Age, Categorical(Participants) | OCS-01 1.5% mg/mL QD | OCS-01 1.5% mg/mL BID | Placebo (Vehicle) BID | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 13 | 22 | 15 | 50 |
| >=65 years | 38 | 29 | 36 | 103 |
| Age, Continuous(years) | OCS-01 1.5% mg/mL QD | OCS-01 1.5% mg/mL BID | Placebo (Vehicle) BID | Total |
|---|---|---|---|---|
| Mean | 68.0 ± 6.86 | 65.8 ± 6.59 | 67.5 ± 8.41 | 67.1 ± 7.34 |
| Sex: Female, Male(Participants) | OCS-01 1.5% mg/mL QD | OCS-01 1.5% mg/mL BID | Placebo (Vehicle) BID | Total |
|---|---|---|---|---|
| Female | 33 | 36 | 32 | 101 |
| Male | 18 | 15 | 19 | 52 |
| Race (NIH/OMB)(Participants) | OCS-01 1.5% mg/mL QD | OCS-01 1.5% mg/mL BID | Placebo (Vehicle) BID | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 1 | 0 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 0 | 1 |
| Black or African American | 3 | 8 | 4 | 15 |
| White | 47 | 42 | 47 | 136 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | OCS-01 1.5% mg/mL QD | OCS-01 1.5% mg/mL BID | Placebo (Vehicle) BID | Total |
|---|---|---|---|---|
| United States | 51 | 51 | 51 | 153 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2019 to primary completion in Jan 2020, 4 months.
Results were first posted in Mar 2022, 2 years 1 month after primary completion. A results delay was requested in Jan 2021.
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This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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