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

NCT ID: NCT03640650

Last Updated: 2021-09-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-15
• Study Completion Date: 2021-03-16

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Dropless Therapy

Intervention Type: COMBINATION_PRODUCT

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

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.

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: 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.

Interventions

Dropless Therapy

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

Intervention Type: COMBINATION_PRODUCT

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.

Intervention Type: DRUG

Other Intervention Names

Triamcinolone acetonide (15mg/ml); Moxifloxacine (1mg/ml); Antibacterial eye drops; Nonsteroidal anti-inflammatory eye drops; Steroid eye drops

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Advance Dosage Forms, Inc.

INDUSTRY

Sponsor Role: collaborator

Imprimis Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

PeriPharm

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Montreal, Quebec, Canada

McGill Academic Eye Center

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

PRE1701

Identifier Type: -

Identifier Source: org_study_id