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

PeriPharm

Status and phase: Terminated; Phase 4

Conditions: Cataract Surgery

Treatments: Combination Product: Dropless Therapy; Drug: Usual Care

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03640650

PRE1701

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Dropless Therapy

Experimental group

Description:

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.

Treatment:

Combination Product: Dropless Therapy

Usual Care

Active Comparator group

Description:

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.

Treatment:

Drug: Usual Care