Cataract SurgeryPhase 4NCT03640650
Economic Impact of Dropless Therapy Versus Usual Care for Cataract Surgery: A Real-World Study.
A Phase 4 study testing Dropless Therapy in people with Cataract Surgery, run by PeriPharm at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract Surgery
- What is being tested?
- Dropless Therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesCanada
- Study dates
- 15 Aug 2018to 16 Mar 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
CIUSSS de l'Est-de-l'Île-de-Montréal (Hôpital Maisonneuve-Rosemont)
Montreal, Quebec, H1T 2M4
McGill Academic Eye Center
Montreal, Quebec, H4A 3J1
About this study
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
- Being tested
- Dropless Therapy, Usual Care
- Keywords
- Sequential bilateral cataract surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dropless TherapyCombination product
Also called Triamcinolone acetonide (15mg/ml), Moxifloxacine (1mg/ml)
The Dropless will be injected, as a single administration, into the vitreous cavity during the cataract surgery.
Usual CareDrug
Also called Antibacterial eye drops, Nonsteroidal anti-inflammatory eye drops, Steroid eye drops
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: Dropless Therapy |
| 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. Receives: Drug: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cataract surgery - related healthcare resource use assessed by number of relevant medications
Chart abstracted and self-reported by participant
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 30 to 45 days following each cataract surgeries
Secondary outcomes (3)
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.
Measured: 30 to 45 days following each cataract surgeries
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.
Measured: 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.
Measured: Through study completion, an average of 20 weeks for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start15 Aug 2018
- Primary completion16 Mar 2021
- Study completion16 Mar 2021
Why it stopped: COVID-19 pandemic leading to uncertainty in the recruitement
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- PeriPharm
- Sponsor type
- University, hospital or other
- Collaborators
- Advance Dosage Forms, Inc., Imprimis Pharmaceuticals, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03640650
- Sponsor's protocol ID
- PRE1701
- Status last verified
- Sep 2021
- First submitted
- 10 May 2018
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Economic Impact of Dropless Therapy Versus Usual Care for Cataract Surgery: A Real-World Study.
- ClinicalTrials.gov ID
- NCT03640650
- Acronym / sponsor ID
- PRE1701
- Conditions
- Cataract Surgery
- Keywords
- Sequential bilateral cataract surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 pandemic leading to uncertainty in the recruitement
- Enrolment
- 80 participants (actual)
- Lead sponsor
- PeriPharmUniversity, hospital or other
- Collaborators
- Advance Dosage Forms, Inc., Imprimis Pharmaceuticals, Inc.
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 16 Mar 2021 (actual)
- Study completion
- 16 Mar 2021 (actual)
- First posted
- 21 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dropless Therapy | Experimental | Combination Product: Dropless TherapySingle 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. |
| Usual Care | Active comparator | Drug: Usual CareThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dropless TherapyAlso: Triamcinolone acetonide (15mg/ml), Moxifloxacine (1mg/ml)The Dropless will be injected, as a single administration, into the vitreous cavity during the cataract surgery. | Combination product | Dropless Therapy |
| Usual CareAlso: Antibacterial eye drops, Nonsteroidal anti-inflammatory eye drops, Steroid eye dropsIn 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. | Drug | Usual Care |
Primary outcome
Cataract surgery - related healthcare resource use assessed by number of relevant medications
Time frame: 30 to 45 days following each cataract surgeries
Chart abstracted and self-reported by participant
Cataract surgery - related healthcare resource use assessed by number of medical visits (outpatient and inpatient visits)
Time frame: 30 to 45 days following each cataract surgeries
Chart abstracted and self-reported by participant
Cataract surgery - related healthcare resource use assessed by number of hospitalizations (ICU and non-ICU)
Time frame: 30 to 45 days following each cataract surgeries
Chart abstracted and self-reported by participant
Cataract surgery - related health care resource use assessed by lengths of hospital stay (ICU and non-ICU)
Time frame: 30 to 45 days following each cataract surgeries
Chart abstracted and self-reported by participant
Cataract surgery - related health care resource use assessed by number of emergency department visit
Time frame: 30 to 45 days following each cataract surgeries
Chart abstracted and self-reported by participant
Cataract surgeries - related health care resource use assessed by number of home visit from nurse
Time frame: 30 to 45 days following each cataract surgeries
Chart abstracted and self-reported by participant
3 secondary outcomes
Medication adherence
Time frame: 30 to 45 days following each cataract surgeries
Medication satisfaction
Time frame: 30 to 45 days following each cataract surgeries
Medication preference
Time frame: Through study completion, an average of 20 weeks for each patient
Results and safety
The study was stopped early (reason given: COVID-19 pandemic leading to uncertainty in the recruitement). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
- Individual participant dataSharing planned: No
Related trials for Cataract Surgery
Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
Cataract
RecruitingObservational study
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Light Adjustable Lens, Objective Depth of Focus
RecruitingObservational study
Anterior Segment Anatomy Assessed by Swept-Source OCT in Ocular Surgery Patients
Cataract, Primary Angle-Closure Glaucoma
RecruitingObservational study
Surgical Procedure Efficiency Evaluation stuDy
Cataract, Vitreous Hemorrhage
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dropless Therapy in people with Cataract Surgery, run by PeriPharm at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: COVID-19 pandemic leading to uncertainty in the recruitement). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cataract surgery - related healthcare resource use assessed by number of relevant medications (time frame: 30 to 45 days following each cataract surgeries). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2021.