Phase 2
N=153
OCS-01 in Treating Inflammation and Pain in Post-cataract Patients
Inflammation Corneal · Pain, Postoperative
Bottom Line
View on ClinicalTrials.gov: NCT04130802 ↗Enrolled (actual)
153
Serious AEs
1.3%
Results posted
Mar 2022
Primary outcome: Primary: Number of Subjects With Absence of Anterior Chamber Cells (i.e. Score of '0') — 26; 34; 10 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- OCS-01 - Dexamethasone Cyclodextrin Nanoparticle Ophthalmic Suspension 1.5% mg/mL (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Oculis
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Absence of Anterior Chamber Cells (i.e. Score of '0') |
26; 34; 10 | — |
| PRIMARY Number of Subjects With Absence of Ocular Pain (i.e. Score of '0') |
37; 32; 23 | — |
Summary
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]).
Eligibility Criteria
Inclusion Criteria
- Provide written informed consent, approved by the appropriate ethics committee;
- Be able to comply with the study requirements and visit schedule;
- Be at least 18 years of age of either sex or any race;
- Be planning to undergo unilateral cataract extraction via phacoemulsification and PCIOL implantation in the study eye;
- Have an anterior chamber cell score ≥ 2 at Visit 2 (Day 1 [18 to 30 hours post-uncomplicated cataract surgery without vitreous loss]);
- Have a pin-hole visual acuity (VA) without any other correction > 20 letters (approximately 20/400) in the operative eye and > 35 letters (approximately 20/200) in the fellow eye as measured using an Early Treatment for Diabetic Retinopathy Study (ETDRS) chart at Visit 1 (Day -1 to Day -28 [prior to surgery]);
- Have a negative urine pregnancy test at Visit 1 (Day -1 to Day -28 [prior to surgery]),
Exclusion Criteria
- Have a known sensitivity or allergy to dexamethasone, corticosteroids, or any of the study medication's components;
- Be monocular;
- Have any intraocular inflammation (e.g. white blood cells or flare) present in either eye at the Visit 1 (Day -1 to Day -28 [prior to surgery]) slit lamp examination;
- Have a score > 0 on the Ocular Pain Assessment at Visit 1 (Day -1 to Day -28 [prior to surgery]) in the study eye;
- Use anti-inflammatory agents, analgesics/pain relievers (including opioids, narcotics, and other pain medications), or immunomodulating agents, systemically or in either eye, and/or use medications for benign prostatic hyperplasia (BPH), from the washout period through the duration of the study.
Data sourced from ClinicalTrials.gov (NCT04130802). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.