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COVID-19 pandemic leading to uncertainty in the recruitement
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| Name | Class |
|---|---|
| Advance Dosage Forms, Inc. | INDUSTRY |
| Imprimis Pharmaceuticals, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dropless Therapy | Combination Product | The Dropless will be injected, as a single administration, into the vitreous cavity during the cataract surgery. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CIUSSS de l'Est-de-l'Île-de-Montréal (Hôpital Maisonneuve-Rosemont) | Montreal | Quebec | H1T 2M4 | Canada | ||
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| ID | Term |
|---|---|
| D014222 | Triamcinolone Acetonide |
| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| 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. |
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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 |
| McGill Academic Eye Center |
| Montreal |
| Quebec |
| H4A 3J1 |
| Canada |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |