A Prospective Clinical Study Evaluating Dexycu vs Prednisolone Acetate 1%

• Status: Completed
• Trial end date: 2020-11-24
• Target enrollment: 0
• Participant gender: All

Summary

This is a post-approval, open-label, randomized, self-controlled prospective clinical study to evaluate the safety and ocular efficacy of Dexycu in controlling postoperative ocular pain and inflammation associated with cataract surgery.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: MDbackline, LLC; Research Insight LLC
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Moxifloxacin; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• A male or female in good general health, greater than 18 years of age at time of screening.

• Must be able to comprehend and willing to give informed consent.

• Woman of child-bearing potential must not be pregnant or lactating.

• Subject has availability, willingness, and sufficient cognitive awareness to comply with exam procedures and able to return for all scheduled study visits.

• Subject with cataract for which routine phacoemulsification extraction and implantation of an intraocular lens has been planned.

• Subject with an OCT of the macula in both eyes that demonstrates no significant pathology.

Exclusion Criteria:

• Subject with any signs of intraocular inflammation in either eye at screening.

• Subject with a known sensitivity to any of the study medications.

• Subject with only one eye with potentially good vision.

• Subject that has undergone prior intraocular surgery in the scheduled surgical eye within the last 6 months or laser surgery within three months prior to screening.

• Subject with pupil abnormalities.

• Subject with corneal abnormalities.

• Subject with a history of chronic/recurrent inflammatory eye disease in either eye.

• Subject with uncontrolled glaucoma.

• Subject expected to undergo surgical intervention and/or ocular laser treatment prior to or during the study period.

• Subject who requires use of systemic or ocular medications that may affect vision, ocular inflammation, or pain.

• Subject with an acute or chronic disease or illness that would increase risk or confound study results, e.g. autoimmune disease, etc.

• Subject with an uncontrolled systemic disease.

• Subject with poorly-controlled diabetes.

• Subject currently participating or has participated in another clinical trial within 30 days prior to enrollment.