A Phase 3,Prospective, Randomized, Double-masked, Placebo-controlled, Parallel Study to Evaluate the Efficacy, PK and Safety of 9% Dexamethasone Intraocular Injection for the Treatment of Inflammation Associatedwith Cataract Surgery

OT-502-001

This is a phase III, prospective, randomised, double-masked, placebo-controlled, parallel-design, multicenter study of the efficacy, safety and pharmacokinetics of 9% dexamethasone intraocular injection for the treatment of inflammation associated with cataract surgery.

2022-08-22

2023-11-24

2024-04-09

Completed

Early phase I

285

Inclusion Criteria: 1. The patient must provide written informed consent by signing the Informed Consent approved by the Institutional Review Board (IRB). 2. Male or female patients at least 40 years of age scheduled for unilateral cataract surgery by phacoemulsification with posterior chamber intraocular lens implantation. 3. The patient must demonstrate best corrected visual acuity (BCVA) of 20/30-20/200 in the study eye and better than 20/200 in the fellow eye. 4. The patient must be considered by the Investigator to have visual acuity potential. greater than 20/30 in the study eye. 5. The patient must have a corneal endothelial cell count by specular microscopy in the study eye of at least 2000 cells/mm2 with normal cell morphology. 6. A female patient of childbearing potential must have a negative pregnancy test on Day 0 and be using an effective method of birth control from Screening for the duration of the study. 7. The patient must be willing and able to understand and comply with the study procedures and to communicate meaningfully with study personnel. Exclusion Criteria: 1. Patients who have used any ocular, topical or oral corticosteroids within 7 days prior to Day 0. 2. Patients who have received a periocular corticosteroid injection in the study eye in the 3 months prior to screening. 3. Patients who have received any intravitreal corticosteroid delivery vehicle (e.g.,Retisert, Ozurdex, Iluvien) in the study eye at any time. 4. Patients who anticipate requiring treatment with any corticosteroids( by any route,except inhalation), during the study. 5. Patients with an allergy or hypersensitivity to dexamethasone. 6. Patients who are known steroid responders (corticosteroid-related intraocular pressure elevation in either eye). 7. Patients who have used topical ocular NSAIDs in the study eye within 15 days prior to Day 0. 8. Patients who have undergone prior intraocular (non-laser) surgery in the study eye within 6 months prior to screening. 9. Patients who have undergone prior intraocular laser surgery in the study eye within 3 months prior to screening. 10. Patients with planned intraocular or laser surgery in the study eye for the duration of the study. 11. Patients with any signs of intraocular inflammation in either eye at screening. 12. Patients with evidence of corneal abnormality or dystrophy (e.g. opacities, guttae,clouding, etc.) or an inability to obtain an acceptable specular micrograph at Screening. 13. Patients with a history of chronic uveitis from any cause in either eye. 14. Patients who have received any prior intravitreal injections in the study eye. 15. Patients with glaucomatous optic neuropathy or glaucomatous visual field loss in either eye. 16. Patients with ocular hypertension with an IOP in the study eye \> 21 mm Hg at Screening with or without treatment with anti-glaucoma monotherapy. 17. Patients with ocular hypertension receiving treatment with two or more anti-glaucoma Medications. 18. Patients treated with any investigational product within 30 days prior to screening or patients enrolled previouslyc study.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 285, 'type': 'ACTUAL'}}

2024-05-24