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Dextenza Within Upper Lid Canaliculus Compared With Lower Lid Canaliculus Following Bilateral Cataract Extraction Surgery With PCIOL.
Phase 4
Waitlist Available
Research Sponsored by Kerry Assil, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed on days 1, 7, 30, 90 for change
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Approved for 100 Other Conditions
Drug Has Already Been Approved
Pivotal Trial
Summary
Assessing DEXTENZA efficacy when placed within the upper eyelid canaliculus as opposed to the lower eyelid canaliculus.
Eligible Conditions
- Eye Pain
- Ocular Inflammation
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed on days 1, 7, 30, 90 for change
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed on days 1, 7, 30, 90 for change
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Post-op pain scores
Post-operative inflammation scores
Secondary study objectives
Absence of CME
Absence of rebound iritis
Ease of Insertion (successful implantation)
+4 moreAwards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Approved for 100 Other Conditions
This treatment demonstrated efficacy for 100 other conditions.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: DEXTENZA placed within the upper canaliculusExperimental Treatment1 Intervention
Dextenza placed within the upper canaliculus following bilateral cataract extraction surgery with posterior chamber intraocular lenses implantation.
Group II: DEXTENZA placed within the lower canaliculusActive Control1 Intervention
Dextenza placed within the lower canaliculus following bilateral cataract extraction surgery with posterior chamber intraocular lenses implantation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
FDA approved
Find a Location
Who is running the clinical trial?
Kerry Assil, MDLead Sponsor