The PRIME Study: A Randomized, Controlled, Prospective Study

Patient Preference Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04549935
• Other study ID #: The PRIME Study
• Status: Recruiting
• Phase: Phase 4
• Start date: September 14, 2020
• Est. completion date: August 27, 2021

Study information

• Verified date: August 2020
• Source: Vance Thompson Vision - MT
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 27, 2021
• Est. primary completion date: August 27, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Dextenza
Dextenza 0.4mg
• Topical Prednisolone
Standard of care topical drop treatment

Locations

Country	Name	City	State
United States	Briana Parker	Bozeman	Montana

Sponsors (1)

Lead Sponsor	Collaborator
Vance Thompson Vision - MT

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of eyes that have CME (Cystoid macular edema) post-operatively	Measured by OCT (Optical Coherence Tomography )	Through Month 1
Secondary	Mean pain score per eye (Group A vs Group B)	Measured by Visual Analog Scale (0-10, 10 being the worst outcome)	Through Month 1
Secondary	Incidence of post-operative corneal haze	measured by OCT (Optical Coherence Tomography)	Through Month 1
Secondary	Grade of post-operative corneal haze	measured by OCT (Optical Coherence Tomography)	Through Month 1
Secondary	Anterior chamber cell count	measured by SUN Working Group Grading Scheme	Through Month 1
Secondary	Uncorrected Visual Acuity	measured by ETDRS chart a 4m	Through Month 1
Secondary	Best Corrected Visual Acuity	measured by ETDRS chart a 4m	Through Month 1