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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04975971
Other study ID # AVC-004
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 9, 2021
Est. completion date May 19, 2021

Study information

Verified date July 2021
Source Advanced Vision Care
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A Retrospective Review of Pain and Inflammation Resolution Outcomes in Patients Who Received DEXTENZA Intracanalicular Dexamethasone (0.4 mg) Insert Prior to or Following Corneal transplant or Cataract surgery


Description:

A Retrospective Review of Pain and Inflammation Resolution Outcomes in Patients Who Received DEXTENZA Intracanalicular Dexamethasone (0.4 mg) Insert, placed within the lower or upper eye lid canaliculus in conjunction with topical steroid Prior to or Following Corneal transplant or Cataract surgery


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date May 19, 2021
Est. primary completion date May 19, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age 18 years and older - Patients who received DEXTENZA insertion perioperatively. Exclusion Criteria: - Any patient who did not receive DEXTENZA insertion

Study Design


Intervention

Drug:
Dextenza 0.4Mg Ophthalmic Insert
DEXTENZA is a corticosteroid intracanalicular insert placed in the punctum, a natural opening in the eye lid, and into the canaliculus and is designed to deliver dexamethasone to the ocular surface for up to 30 days without preservatives.

Locations

Country Name City State
United States Advanced Vision Care Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
Nicole Fram M.D.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Tyson SL, Bafna S, Gira JP, Goldberg DF, Jones JJ, Jones MP, Kim JK, Martel JM, Nordlund ML, Piovanetti-Perez IK, Singh IP, Metzinger JL, Mulani D, Sane S, Talamo JH, Goldstein MH; Dextenza Study Group. Multicenter randomized phase 3 study of a sustained- — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Mean change in pain score As measured with the visual analog scale (VAS); between 0 and 100; 0 meaning no pain and 100 meaning worse pain possible Assessed for 3 months after drug insertion
Primary Mean change in inflammation (Cell and Flare) scores As measured by SUN (Standardization on Uveitis Nomenclature) grading scale: absence of cell to be defined as a grade of 0-0.5 and absence of flare to be defined as a grade of: 0-1 Assessed for 3 months after drug insertion
Secondary Resolution of pain Resolution of pain as assessed by aquestionnaire in post-op visits Assessed for 1 months after drug insertion
Secondary Resolution of anterior chamber inflammation Resolution of anterior chamber inflammation as measured by SUN grading at the slitlamp in post-op visits Assessed for 3 months after drug insertion
Secondary Proportion of eyes requiring additional post-operative therapy Proportion of eyes requiring additional post-operative therapy for pain and inflammation Assessed for 3 months after drug insertion
Secondary Number of patient call-backs regarding post-operative pain Number of patient call-backs regarding post-operative pain and medication management Assessed for 3 months after drug insertion
Secondary Number of pharmacy call-backs regarding post-operative medication Number of pharmacy call-backs regarding post-operative medication management Assessed for 3 months after drug insertion
Secondary Adverse events Incidence and severity of adverse events Assessed for 3 months after drug insertion
Secondary Mean change in IOP Mean change in IOP over post-op visits Assessed for 3 months after drug insertion
Secondary Change in BCVA Change in BCVA over post op visits Assessed for 3 months after drug insertion
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