The PRIME Study: A Randomized, Controlled, Prospective Study

NCT04549935 | Recruiting Phase 4 FDA Drug

• 1 other identifier: The PRIME Study
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient Preference; Patient Outcomes; Post-Operative Inflammation; Grade of Post-Operative Cystoid Macular Edema; Rate of Post-Operative Cystoid Macular Edema

Outcome Measures

Primary Outcomes (1)

• 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)

  Through Month 1

Secondary Outcomes (7)

• Percentage of eyes that have CME (Cystoid macular edema) post-operatively

  Through Month 1

• Mean pain score per eye (Group A vs Group B)

  Through Month 1

• Incidence of post-operative corneal haze

  Through Month 1

• Grade of post-operative corneal haze

  Through Month 1

• Anterior chamber cell count

  Through Month 1

Study Arms (2)

Group A Dextenza

ACTIVE COMPARATOR

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

Group B Topical Prednisolone

ACTIVE COMPARATOR

Drug: Topical Prednisolone Standard of care topical drop treatment

Drug: Topical Prednisolone

Interventions

Dextenza DRUG

Dextenza 0.4mg

Group A Dextenza

Topical Prednisolone DRUG

Standard of care topical drop treatment

Group B Topical Prednisolone

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vance Thompson Vision - MT: lead

Study Sites (1)

Briana Parker

Bozeman, Montana, 59718, United States

RECRUITING

MeSH Terms

Conditions

Patient Preference

Interventions

Calcium Dobesilate; Prednisolone

Condition Hierarchy (Ancestors)

Patient Satisfaction; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 16, 2020
• Study Start: September 14, 2020
• Primary Completion: August 27, 2021
• Study Completion: August 27, 2021
• Last Updated: September 16, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)