OCS-01 in Treating Inflammation and Pain in Post-cataract Patients (NCT04130802) | Clinical Trial Compass
CompletedPhase 2
OCS-01 in Treating Inflammation and Pain in Post-cataract Patients
United States153 participantsStarted 2019-09-27
Plain-language 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 \[BID\]).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
ā. Provide written informed consent, approved by the appropriate ethics committee;
ā. Be able to comply with the study requirements and visit schedule;
ā. Be at least 18 years of age of either sex or any race;
ā. Be planning to undergo unilateral cataract extraction via phacoemulsification and PCIOL implantation in the study eye;
ā. Have an anterior chamber cell score ā„ 2 at Visit 2 (Day 1 \[18 to 30 hours post-uncomplicated cataract surgery without vitreous loss\]);
ā. 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 \[prior to surgery\]);
ā. Have a negative urine pregnancy test at Visit 1 (Day -1 to Day -28 \[prior to surgery\]),
Exclusion criteria
ā. Have a known sensitivity or allergy to dexamethasone, corticosteroids, or any of the study medication's components;
ā. Be monocular;
ā. 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;
ā. Have a score \> 0 on the Ocular Pain Assessment at Visit 1 (Day -1 to Day -28 \[prior to surgery\]) in the study eye;
What they're measuring
1
Number of Subjects With Absence of Anterior Chamber Cells (i.e. Score of '0')
Timeframe: at Day 15 (visit 6)
2
Number of Subjects With Absence of Ocular Pain (i.e. Score of '0')
ā. 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.