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

NCT03640650 | Terminated Phase 4

• 1 other identifier: PRE1701
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Sequential bilateral cataract surgery

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

• Medication adherence

  30 to 45 days following each cataract surgeries

• Medication satisfaction

  30 to 45 days following each cataract surgeries

• Medication preference

  Through study completion, an average of 20 weeks for each patient

Study Arms (2)

Dropless Therapy

EXPERIMENTAL

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

Usual Care

ACTIVE COMPARATOR

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

Interventions

Dropless Therapy COMBINATION_PRODUCT

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

Also known as: Triamcinolone acetonide (15mg/ml), Moxifloxacine (1mg/ml)

Dropless Therapy

Usual Care DRUG

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.

Also known as: Antibacterial eye drops, Nonsteroidal anti-inflammatory eye drops, Steroid eye drops

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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);
• Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation;
• 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;
• Patients with any history of allergy to the usual care post-operative eye drops or the components of Dropless.

Sponsors & Collaborators

• PeriPharm: lead
• Advance Dosage Forms, Inc.: collaborator
• Imprimis Pharmaceuticals, Inc.: collaborator

Study Sites (2)

CIUSSS de l'Est-de-l'Île-de-Montréal (Hôpital Maisonneuve-Rosemont)

Montreal, Quebec, H1T 2M4, Canada

Location

McGill Academic Eye Center

Montreal, Quebec, H4A 3J1, Canada

Location

MeSH Terms

Interventions

Triamcinolone Acetonide

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2018
• First Posted: August 21, 2018
• Study Start: August 15, 2018
• Primary Completion: March 16, 2021
• Study Completion: March 16, 2021
• Last Updated: September 21, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)