OCS-01 in Treating Inflammation and Pain in Post-cataract Patients
Condition: Inflammation Corneal; Pain, Postoperative
MeSH terms: Cataract; Keratitis; Inflammation; Pain, Postoperative
Intervention: OCS-01 - Dexamethasone Cyclodextrin Nanoparticle Ophthalmic Suspension 1.5% mg/mL; Placebo
Intervention description: OCS-01 eye drops; Vehicle eye drops
Intervention MeSH terms: Dexamethasone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-masked, placebo (vehicle)-controlled study evaluating the efficacy and safety of two doses of OCS-01 compared to vehicle
Masking: Double (Participant, Outcomes Assessor)
Masking description: For masking purposes, each dosing box and the pouches within it will be labeled either "AM" or "PM." Dosing boxes and pouches will be labeled this way regardless of whether the product within the 2 boxes is the same (i.e. OCS-01 BID and placebo treatment arms) or different (i.e. OCS-01 QD).
Enrollment: 153.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: post-cataract,; inflammation; Pain; post-surgery; corticosteroid; anterior chamber cells; flares

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:

          1. Provide written informed consent, approved by the appropriate ethics committee;

          2. Be able to comply with the study requirements and visit schedule;

          3. Be at least 18 years of age of either sex or any race;

          4. Be planning to undergo unilateral cataract extraction via phacoemulsification and
             PCIOL implantation in the study eye;

          5. Have an anterior chamber cell score ≥ 2 at Visit 2 (Day 1 [18 to 30 hours
             post-uncomplicated cataract surgery without vitreous loss]);

          6. 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]);

          7. Have a negative urine pregnancy test at Visit 1 (Day -1 to Day -28 [prior to
             surgery]),

        Exclusion Criteria:

          1. Have a known sensitivity or allergy to dexamethasone, corticosteroids, or any of the
             study medication's components;

          2. Be monocular;

          3. 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;

          4. Have a score > 0 on the Ocular Pain Assessment at Visit 1 (Day -1 to Day -28 [prior to
             surgery]) in the study eye;

          5. 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.