Status:
COMPLETED
OCS-01 in Treating Inflammation and Pain in Post-cataract Patients
Lead Sponsor:
Oculis
Conditions:
Inflammation Corneal
Pain, Postoperative
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 p...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2020
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT04130802
Start Date
September 27 2019
End Date
January 31 2020
Last Update
September 10 2025
Active Locations (4)
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1
Medical cennre
Petaluma, California, United States, 94954
2
Medical center
Roseburg, Oregon, United States, 97471
3
Medical center
Houston, Texas, United States, 77008
4
Medical center
San Antonio, Texas, United States, 78229