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

Cataract Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03640650
• Other study ID #: PRE1701
• Status: Terminated
• Phase: Phase 4
• Start date: August 15, 2018
• Est. completion date: March 16, 2021

Study information

• Verified date: September 2021
• Source: PeriPharm
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: March 16, 2021
• Est. primary completion date: March 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Cataract Surgery

Intervention

Combination Product:
• Dropless Therapy
The Dropless will be injected, as a single administration, into the vitreous cavity during the cataract surgery.

Drug:
• 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.

Locations

Country	Name	City	State
Canada	CIUSSS de l'Est-de-l'Île-de-Montréal (Hôpital Maisonneuve-Rosemont)	Montreal	Quebec
Canada	McGill Academic Eye Center	Montreal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
PeriPharm	Advance Dosage Forms, Inc., Imprimis Pharmaceuticals, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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.	30 to 45 days following each cataract surgeries
Secondary	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