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

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.

Study Overview

• Status: Terminated
• Conditions: Cataract Surgery
• Intervention / Treatment: Combination product: Dropless Therapy; Drug: Usual Care

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • CIUSSS de l'Est-de-l'Île-de-Montréal (Hôpital Maisonneuve-Rosemont)
    • Montreal, Quebec, Canada, H4A 3J1
      • McGill Academic Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 18 years of age or older;
2. Undergoing delayed sequential bilateral cataract extraction with intraocular lens implantation;
3. Delayed sequential bilateral cataract surgery performed in a day surgery setting;
4. Second cataract surgery planned within 3 months following the date of the first cataract surgery;
5. Ability to read and understand English or French;
6. Signature of ICF.

Exclusion Criteria:

1. Patients with other ophthalmic conditions such as glaucoma, corneal disease, agerelated macular degeneration, and active uveitis* (*In line with current clinical practice in Canada, uveitis should be inactive for 3 months to be included in the study);
2. Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation;
3. Participation in any investigational ophthalmic-related drug or device trial within the 30 days prior to the start date of this trial or participation in any current investigational ophthalmic-related drug or device trial;
4. Patients with any history of allergy to the usual care post-operative eye drops or the components of Dropless.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dropless Therapy; Single used, pre-mixed, centrally compounded injectable that contains 15 mg/ml of triamcinolone acetonide and 1 mg/ml of moxifloxacin. This preservative-free suspension is injected at a dose of 0.2 mg into the posterior chamber, for a total drug delivery of 3 mg of triamcinolone acetonide and 0.2 mg of moxifloxacin. At the time of cataract surgery, Dropless is intended to be injected as a single administration into the anterior vitreous after the insertion of the IOL implant, with a 27 or 30-gauge cannula via a transzonular or transsceral pars plana injection, just before rinsing the viscoelastic fluid.	Combination product: Dropless Therapy; The Dropless will be injected, as a single administration, into the vitreous cavity during the cataract surgery.; Other Names: Triamcinolone acetonide (15mg/ml); Moxifloxacine (1mg/ml)
Active Comparator: Usual Care; This therapy usually comprises an antibiotic, a steroid and in some cases a nonsteroidal anti-inflammatory drug (NSAID). Antibacterial drops are usually given at the end of surgery and are continued for one week after the surgery. Steroid drops are usually started the day of surgery and then tapered down over 3 to 4 weeks. When prescribed, NSAIDs are usually started 2 or 3 days before surgery, or started the day of surgery, and continued for 3 or 4 times a day for 3 to 4 weeks.	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.; Other Names: Antibacterial eye drops; Nonsteroidal anti-inflammatory eye drops; Steroid eye drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cataract surgery - related healthcare resource use assessed by number of relevant medications	Chart abstracted and self-reported by participant	30 to 45 days following each cataract surgeries
Cataract surgery - related healthcare resource use assessed by number of medical visits (outpatient and inpatient visits)	Chart abstracted and self-reported by participant	30 to 45 days following each cataract surgeries
Cataract surgery - related healthcare resource use assessed by number of hospitalizations (ICU and non-ICU)	Chart abstracted and self-reported by participant	30 to 45 days following each cataract surgeries
Cataract surgery - related health care resource use assessed by lengths of hospital stay (ICU and non-ICU)	Chart abstracted and self-reported by participant	30 to 45 days following each cataract surgeries
Cataract surgery - related health care resource use assessed by number of emergency department visit	Chart abstracted and self-reported by participant	30 to 45 days following each cataract surgeries
Cataract surgeries - related health care resource use assessed by number of home visit from nurse	Chart abstracted and self-reported by participant	30 to 45 days following each cataract surgeries

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication adherence	The investigator will question the participant on his adherence to drop regimen. Descriptive results of the adherence, based on self-reported adherence, will be reported in accordance to patients' responses for each question.	30 to 45 days following each cataract surgeries
Medication satisfaction	The investigator will question the patient in order to describe the satisfaction to drop regimen or Dropless. Descriptive results of the satisfaction, based on self-reported satisfaction, will be reported in accordance to patients' responses for each question.	30 to 45 days following each cataract surgeries
Medication preference	The investigator will question the patient about his preference between the usual care (eye drops) and Dropless. Descriptive results of the preference will be reported in accordance to patients' responses.	Through study completion, an average of 20 weeks for each patient

Collaborators and Investigators

• Sponsor: PeriPharm
• Collaborators: Imprimis Pharmaceuticals, Inc.; Advance Dosage Forms, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2018
• Primary Completion (Actual): March 16, 2021
• Study Completion (Actual): March 16, 2021

Study Registration Dates

• First Submitted: May 10, 2018
• First Submitted That Met QC Criteria: August 20, 2018
• First Posted (Actual): August 21, 2018

Study Record Updates

• Last Update Posted (Actual): September 21, 2021
• Last Update Submitted That Met QC Criteria: September 14, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Sequential bilateral cataract surgery
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pharmaceutical Solutions; Anti-Inflammatory Agents; Ophthalmic Solutions; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
• Other Study ID Numbers: PRE1701

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No