Overview

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.