Back to resultsEconomic Impact of Dropless Therapy Versus Usual Care for Cataract Surgery: A Real-World Study.
Primary Purpose
Cataract Surgery
Status
Terminated
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Dropless Therapy
Usual Care
Sponsored by
About this trial
This is an interventional prevention trial for Cataract Surgery focused on measuring Sequential bilateral cataract surgery
Eligibility Criteria
Inclusion Criteria:
- 18 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.
Exclusion Criteria:
- 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.
Sites / Locations
- CIUSSS de l'Est-de-l'Île-de-Montréal (Hôpital Maisonneuve-Rosemont)
- McGill Academic Eye Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dropless Therapy
Usual Care
Arm 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.
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.
Outcomes
Primary Outcome Measures
Cataract surgery - related healthcare resource use assessed by number of relevant medications
Chart abstracted and self-reported by participant
Cataract surgery - related healthcare resource use assessed by number of medical visits (outpatient and inpatient visits)
Chart abstracted and self-reported by participant
Cataract surgery - related healthcare resource use assessed by number of hospitalizations (ICU and non-ICU)
Chart abstracted and self-reported by participant
Cataract surgery - related health care resource use assessed by lengths of hospital stay (ICU and non-ICU)
Chart abstracted and self-reported by participant
Cataract surgery - related health care resource use assessed by number of emergency department visit
Chart abstracted and self-reported by participant
Cataract surgeries - related health care resource use assessed by number of home visit from nurse
Chart abstracted and self-reported by participant
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT03640650
First Posted
May 10, 2018
Last Updated
September 14, 2021
Sponsor
PeriPharm
Collaborators
Advance Dosage Forms, Inc., Imprimis Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03640650
Brief Title
Economic Impact of Dropless Therapy Versus Usual Care for Cataract Surgery: A Real-World Study.
Official Title
Economic Impact of Dropless Therapy Versus Usual Care for Cataract Surgery: A Real-World Study.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
COVID-19 pandemic leading to uncertainty in the recruitement
Study Start Date
August 15, 2018 (Actual)
Primary Completion Date
March 16, 2021 (Actual)
Study Completion Date
March 16, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PeriPharm
Collaborators
Advance Dosage Forms, Inc., Imprimis Pharmaceuticals, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract Surgery
Keywords
Sequential bilateral cataract surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dropless Therapy
Arm Type
Experimental
Arm 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.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm 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.
Intervention Type
Combination Product
Intervention Name(s)
Dropless Therapy
Other Intervention Name(s)
Triamcinolone acetonide (15mg/ml), Moxifloxacine (1mg/ml)
Intervention Description
The Dropless will be injected, as a single administration, into the vitreous cavity during the cataract surgery.
Intervention Type
Drug
Intervention Name(s)
Usual Care
Other Intervention Name(s)
Antibacterial eye drops, Nonsteroidal anti-inflammatory eye drops, Steroid eye drops
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cataract surgery - related healthcare resource use assessed by number of relevant medications
Description
Chart abstracted and self-reported by participant
Time Frame
30 to 45 days following each cataract surgeries
Title
Cataract surgery - related healthcare resource use assessed by number of medical visits (outpatient and inpatient visits)
Description
Chart abstracted and self-reported by participant
Time Frame
30 to 45 days following each cataract surgeries
Title
Cataract surgery - related healthcare resource use assessed by number of hospitalizations (ICU and non-ICU)
Description
Chart abstracted and self-reported by participant
Time Frame
30 to 45 days following each cataract surgeries
Title
Cataract surgery - related health care resource use assessed by lengths of hospital stay (ICU and non-ICU)
Description
Chart abstracted and self-reported by participant
Time Frame
30 to 45 days following each cataract surgeries
Title
Cataract surgery - related health care resource use assessed by number of emergency department visit
Description
Chart abstracted and self-reported by participant
Time Frame
30 to 45 days following each cataract surgeries
Title
Cataract surgeries - related health care resource use assessed by number of home visit from nurse
Description
Chart abstracted and self-reported by participant
Time Frame
30 to 45 days following each cataract surgeries
Secondary Outcome Measure Information:
Title
Medication adherence
Description
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.
Time Frame
30 to 45 days following each cataract surgeries
Title
Medication satisfaction
Description
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.
Time Frame
30 to 45 days following each cataract surgeries
Title
Medication preference
Description
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.
Time Frame
Through study completion, an average of 20 weeks for each patient
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
CIUSSS de l'Est-de-l'Île-de-Montréal (Hôpital Maisonneuve-Rosemont)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
McGill Academic Eye Center
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Economic Impact of Dropless Therapy Versus Usual Care for Cataract Surgery: A Real-World Study.
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