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Economic Impact of Dropless Therapy Versus Usual Care for Cataract Surgery: A Real-World Study.

NCT03640650 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-09-21

No results posted yet for this study

Summary

This real-life Health Economics and Outcome Research (HEOR) study will enable to evaluate the economic impact of Dropless therapy for the prophylactic treatment of inflammation and infection after routine cataract surgery. This prospective randomized controlled crossover open-label study will estimate resource utilization and cost attributable to patients' management following a cataract surgery and until last follow-up visit and adherence, satisfaction and preference between usual care and Dropless in a real-life setting.

Data collected will include patients' characteristics and demographics, medical information, cataract surgery information, healthcare resource utilization, patients' adherence to topical ophthalmic medications as well as patients' satisfaction to both treatment and preference between usual care and Dropless. Patients will fill a set of questionnaires at their recruitment in the study and at their last follow-up visit for their two cataracts surgery.

Conditions

  • Cataract Surgery

Interventions

COMBINATION_PRODUCT

Dropless Therapy

The Dropless will be injected, as a single administration, into the vitreous cavity during the cataract surgery.

DRUG

Usual Care

In order to reflect real-world clinical practice, the choice of topical ophthalmic medications as well as dosage, posology, and duration of treatment will be left to the discretion of the treating ophthalmologist.

Sponsors & Collaborators

  • Advance Dosage Forms, Inc.

    collaborator INDUSTRY

  • Imprimis Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • PeriPharm

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-15
Primary Completion
2021-03-16
Completion
2021-03-16

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03640650 on ClinicalTrials.gov