The PRIME Study: A Randomized, Controlled, Prospective Study

• Sponsor: Vance Thompson Vision - MT (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04549935
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 11.4
• Patients Per Site Per Month: 1.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Patient Preference; Patient Outcomes; Post-Operative Inflammation; Grade of Post-Operative Cystoid Macular Edema; Rate of Post-Operative Cystoid Macular Edema	Drug: Dextenza; Drug: Topical Prednisolone	Phase 4

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• 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)
• Anticipated Study Start Date: Sep 14, 2020
• Anticipated Primary Completion Date: Aug 27, 2021
• Anticipated Study Completion Date: Aug 27, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group A Dextenza 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: Dextenza; Dextenza 0.4mg
Active Comparator: Group B Topical Prednisolone Drug: Topical Prednisolone Standard of care topical drop treatment	Drug: Topical Prednisolone; Standard of care topical drop treatment

Outcome Measures

Primary Outcome Measures

1. Patient Preference [Through Month 1]

   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

1. Percentage of eyes that have CME (Cystoid macular edema) post-operatively [Through Month 1]

   Measured by OCT (Optical Coherence Tomography )

2. Mean pain score per eye (Group A vs Group B) [Through Month 1]

   Measured by Visual Analog Scale (0-10, 10 being the worst outcome)

3. Incidence of post-operative corneal haze [Through Month 1]

   measured by OCT (Optical Coherence Tomography)

4. Grade of post-operative corneal haze [Through Month 1]

   measured by OCT (Optical Coherence Tomography)

5. Anterior chamber cell count [Through Month 1]

   measured by SUN Working Group Grading Scheme

6. Uncorrected Visual Acuity [Through Month 1]

   measured by ETDRS chart a 4m

7. Best Corrected Visual Acuity [Through Month 1]

   measured by ETDRS chart a 4m

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Briana Parker	Bozeman	Montana	United States	59718

Sponsors and Collaborators

• Vance Thompson Vision - MT

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vance Thompson Vision - MT
• ClinicalTrials.gov Identifier: NCT04549935
• Other Study ID Numbers: The PRIME Study
• First Posted: Sep 16, 2020
• Last Update Posted: Sep 16, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Macular Edema; Inflammation; Edema; Prednisolone

Study Results

No Results Posted as of Sep 16, 2020