Intracameral Antibiotic Safety Study

• Status: Not yet recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this study is to determine the safety (but not efficacy in preventing infection) of sterile-packaged and pre-loaded injectable solutions of both vancomycin and moxifloxacin at certain dosages and concentrations as prepared by a compounding pharmacy when used intracamerally at the time of cataract surgery.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Panhandle Eye Group, LLP
• Treatments: Anti-Bacterial Agents; Fluoroquinolones; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Vancomycin

Criteria

Inclusion Criteria:

• Diagnosis of visually significant cataract

• Appropriate candidate for cataract surgery

Exclusion Criteria:

• Not willing to undergo an investigational treatment or are unable to cooperate well enough to safely perform the procedure under the protocol guidelines

• Has known allergies to the pre-/intra-/post-operative medications or preservatives in the medications will also be excluded

• Has significant ocular co-morbidities in one or both eyes which may include (but is not limited to): advanced glaucoma, advanced or active macular degeneration, Fuchs corneal dystrophy, prior corneal transplantation, advanced diabetic eye disease, history of retinal detachment or any patient that would require billing a complex cataract procedure for any reason

• Has a known history of a condition which causes an immuno-compromised host state