search
Back to results

The PRIME Study: A Randomized, Controlled, Prospective Study

Primary Purpose

Patient Preference, Patient Outcomes, Post-Operative Inflammation

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dextenza
Topical Prednisolone
Sponsored by
Vance Thompson Vision - MT
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patient Preference

Eligibility Criteria

22 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Any adult patient who is planned to undergo bilateral RLE surgery with BCVA 20/30 or better
  • Willing and able to comply with clinic visits and study related procedures
  • Willing and able to sign the informed consent form

Exclusion Criteria:

  • Patients under the age of 22 or above the age of 75
  • Patients who are pregnant (must be ruled out in a women of child-bearing age with pregnancy test).
  • Patients with active infectious ocular or extraocular disease.
  • Patients actively treated with local or systemic immunosuppression including systemic corticosteriods
  • Paitents with know hypersensitivity to Dexamethasone
  • Patients with severe disease that warrants critical attentino, deemed unsafe for the study by the investigator
  • Patients with a history of ocular inflammation or macular edema
  • Patients with allergy or inability to receive intracameral antibiotic
  • Patients on systemic non-steroidal anti-inflammatory drugs (NSAID) grater than 1,200 mg/day
  • Patient with a corticosteriod implant (i.e. Ozurdex).
  • Patient with corneal pathology which pre-disposes them to unsatisfactory outcomes

Sites / Locations

  • Briana ParkerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group A Dextenza

Group B Topical Prednisolone

Arm Description

Drug: Dextenza 0.4mg Opthalmic Insert The insert, containing 0.4 mg of active pharmaceutical product, is placed within the canaliculus to provide a sustained and tapered delivery of drug to the ocular surface over 30 days after a one-time insertion, The attributes of the insert reduce risks for improper corticosteriod tapering and unwanted peaks and troughs in drug concentration.

Drug: Topical Prednisolone Standard of care topical drop treatment

Outcomes

Primary Outcome Measures

Patient Preference
As measured by adapted COMTOL (Comparison of Ophthalmic Medications for Tolerability) survey (This is measured on a scale of 1-10 with 10 being a worse outcome)

Secondary Outcome Measures

Percentage of eyes that have CME (Cystoid macular edema) post-operatively
Measured by OCT (Optical Coherence Tomography )
Mean pain score per eye (Group A vs Group B)
Measured by Visual Analog Scale (0-10, 10 being the worst outcome)
Incidence of post-operative corneal haze
measured by OCT (Optical Coherence Tomography)
Grade of post-operative corneal haze
measured by OCT (Optical Coherence Tomography)
Anterior chamber cell count
measured by SUN Working Group Grading Scheme
Uncorrected Visual Acuity
measured by ETDRS chart a 4m
Best Corrected Visual Acuity
measured by ETDRS chart a 4m

Full Information

First Posted
August 31, 2020
Last Updated
September 14, 2020
Sponsor
Vance Thompson Vision - MT
search

1. Study Identification

Unique Protocol Identification Number
NCT04549935
Brief Title
The PRIME Study: A Randomized, Controlled, Prospective Study
Official Title
A Randomized, Controlled, PRospective Study of the Effectiveness and Safety of the Ocular Therapeutix Dextenza (Dexamethasone Ophthalmic Insert) 0.4 mg for the treatMEnt of Post-operative Inflammation in Patients Who Plan to Undergo Refractive Lens Exchange (RLE)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Recruiting
Study Start Date
September 14, 2020 (Anticipated)
Primary Completion Date
August 27, 2021 (Anticipated)
Study Completion Date
August 27, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vance Thompson Vision - MT

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

Brief Summary
To investigate the outcomes of patients undergoing bilateral RLE surgery with treatment of dexamethasone intracanilicular insert compared to topical standard care steroid. Desiged to look at patient preference comparing the insert to drops and will also look at patient outcomes including inflammatin and risk of cystoid macular edema post-operatively.
Detailed Description
A Randomized, Controlled, Prospective Study design in which one eye (Group A) receives Dextenza and the second eye (Group B) receives prednisolone acetate 1% QID 1 week, TID 1 week, BID 1 week, and QD 1week, following bilateral RLE surgery. All eyes will receive topical moxifloxacin QID for one week and topical Ilevro QD for 4 weeks. Moxifloxacin and Ilevero are used in post-op regardless of the research. Post-operative evaluations to be performed on Day 1, Day 7, and 1 Month.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patient Preference, Patient Outcomes, Post-Operative Inflammation, Grade of Post-Operative Cystoid Macular Edema, Rate of Post-Operative Cystoid Macular Edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A Dextenza
Arm Type
Active Comparator
Arm Description
Drug: Dextenza 0.4mg Opthalmic Insert The insert, containing 0.4 mg of active pharmaceutical product, is placed within the canaliculus to provide a sustained and tapered delivery of drug to the ocular surface over 30 days after a one-time insertion, The attributes of the insert reduce risks for improper corticosteriod tapering and unwanted peaks and troughs in drug concentration.
Arm Title
Group B Topical Prednisolone
Arm Type
Active Comparator
Arm Description
Drug: Topical Prednisolone Standard of care topical drop treatment
Intervention Type
Drug
Intervention Name(s)
Dextenza
Intervention Description
Dextenza 0.4mg
Intervention Type
Drug
Intervention Name(s)
Topical Prednisolone
Intervention Description
Standard of care topical drop treatment
Primary Outcome Measure Information:
Title
Patient Preference
Description
As measured by adapted COMTOL (Comparison of Ophthalmic Medications for Tolerability) survey (This is measured on a scale of 1-10 with 10 being a worse outcome)
Time Frame
Through Month 1
Secondary Outcome Measure Information:
Title
Percentage of eyes that have CME (Cystoid macular edema) post-operatively
Description
Measured by OCT (Optical Coherence Tomography )
Time Frame
Through Month 1
Title
Mean pain score per eye (Group A vs Group B)
Description
Measured by Visual Analog Scale (0-10, 10 being the worst outcome)
Time Frame
Through Month 1
Title
Incidence of post-operative corneal haze
Description
measured by OCT (Optical Coherence Tomography)
Time Frame
Through Month 1
Title
Grade of post-operative corneal haze
Description
measured by OCT (Optical Coherence Tomography)
Time Frame
Through Month 1
Title
Anterior chamber cell count
Description
measured by SUN Working Group Grading Scheme
Time Frame
Through Month 1
Title
Uncorrected Visual Acuity
Description
measured by ETDRS chart a 4m
Time Frame
Through Month 1
Title
Best Corrected Visual Acuity
Description
measured by ETDRS chart a 4m
Time Frame
Through Month 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Any adult patient who is planned to undergo bilateral RLE surgery with BCVA 20/30 or better Willing and able to comply with clinic visits and study related procedures Willing and able to sign the informed consent form Exclusion Criteria: Patients under the age of 22 or above the age of 75 Patients who are pregnant (must be ruled out in a women of child-bearing age with pregnancy test). Patients with active infectious ocular or extraocular disease. Patients actively treated with local or systemic immunosuppression including systemic corticosteriods Paitents with know hypersensitivity to Dexamethasone Patients with severe disease that warrants critical attentino, deemed unsafe for the study by the investigator Patients with a history of ocular inflammation or macular edema Patients with allergy or inability to receive intracameral antibiotic Patients on systemic non-steroidal anti-inflammatory drugs (NSAID) grater than 1,200 mg/day Patient with a corticosteriod implant (i.e. Ozurdex). Patient with corneal pathology which pre-disposes them to unsatisfactory outcomes
Facility Information:
Facility Name
Briana Parker
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59718
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Briana Parker
Phone
406-599-5961
Email
briana.parker@vancethompsonvision.com
First Name & Middle Initial & Last Name & Degree
Keeley Puls
Phone
605 371-7075
Email
kpuls@vancethompsonvision.com
First Name & Middle Initial & Last Name & Degree
Russell Swan, MD
First Name & Middle Initial & Last Name & Degree
Travis Whitt, OD
First Name & Middle Initial & Last Name & Degree
Seirra Steiner, OD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The PRIME Study: A Randomized, Controlled, Prospective Study

We'll reach out to this number within 24 hrs