Patient PreferencePhase 4CIMPLIFYNCT04205916
A Trial Evaluating Patient Preference of Dropless vs Drops Post Cataract Surgery
A Phase 4 study testing Dexamethasone in people with Patient Preference, run by Ophthalmic Consultants of Long Island at 1 site in United States.
Trial summary
To evaluate the safety and ocular efficacy of Dextenza in combination with an intracameral antibiotic and NSAID in controlling post-operative ocular pain and inflammation compared to standard of care topical therapy in patients undergoing bilateral cataract surgery. Read more about this study
- Who is it for?
- Ages 22 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Patient Preference
- What is being tested?
- Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2019to 1 Dec 2020
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 22 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A male or female subject in good general health (as determined by the Investigator), > 22 years of age at the time of the screening visit
- A subject must be willing and able to sign informed consent
- A woman of child-bearing potential must not be pregnant or lactating, must have a negative pregnancy test at screening and must be practicing an adequate method of birth control. Acceptable methods of birth control include intrauterine device (IUD), oral, dermal ("patch"), implant or injected contraceptives; tubal ligation; and barrier methods with spermicide.
- A subject has the availability, willingness and sufficient cognitive awareness to comply with exam procedures and able to return for all scheduled study visits
- A subject with a cataract for which routine phacoemulsification extraction and implantation of an intraocular lens has been planned
Who cannot join
- A subject with a history of complications, adverse events, trauma or disease in the nasolacrimal area, whether or not it was due to punctal plug wear, including but not limited to dacryocystitis, inflammation or canaliculitis in either eye
- A subject with structural lid abnormalities (e.g., ectropion, entropion) in their schedule surgical eye
- A subject with a puncta >0.9 mm prior to dilation in their scheduled surgical eye
- A subject experiencing significant ocular pain or discomfort in either eye at the screening visit or on the day the plug is to be inserted
- A subject with any moderate to severe lid, conjunctival or corneal findings in either eye at the screening visit
- A subject with any signs of intraocular inflammation (cells/flare) in either eye at the screening visit
Show all 38Show fewer
- A subject with a known sensitivity to any of the study medications; A subject with a known or suspected allergy or hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs), or to any component of the test article
- A subject with a history as a steroid responder
- A subject with capsule or zonular abnormalities with preoperative lens tilt and/or decentration (e.g., Marfan's syndrome), or may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)
- A subject has a history of ocular trauma in their scheduled surgical eye
- A subject that has undergone prior intraocular surgery in the scheduled surgical eye within the last 6 months or laser surgery within three months prior to screening
- A subject with pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 3.5 mm under mesopic/scotopic conditions) in their scheduled surgical eye.
- A subject with a corneal abnormality (e.g., stromal, epithelial or endothelial dystrophies) in their scheduled surgical eye
- A subject with evidence of keratoconus or significant irregular astigmatism on pre-operative topography in their scheduled surgical eye
- A subject with evidence of Epithelial Basement Membrane Dystrophy on slit-lamp exam
- A subject that has been wearing Poly Methyl Metharcylate (PMMA) lenses within 6 months, gas permeable lenses within one month, or extended-wear or daily soft contact lens within 7 days of their scheduled surgery
- A subject with an inability to achieve keratometric stability for contact lens wearers
- A subject with a history of chronic/recurrent inflammatory eye disease (e.g., scleritis, uveitis, herpes keratitis) in either eye
- A subject with uncontrolled glaucoma
- A subject that requires an Limbal Relaxing Incision (LRI) or AI procedure before, during or after cataract surgery
- A subject that may or is expected to undergo surgical intervention and/or ocular laser treatment prior to or during the study period
- A subject that requires the use of systemic or ophthalmic Nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroid medications during the study period.
- A subject that requires the use of system or ocular medications that may affect vision, ocular inflammation or pain
- A subject with an acute or chronic disease, or illness, that would increase risk or confound study results (e.g., autoimmune disease, connective tissue disease, immunocompromised, suspected glaucoma, glaucomatous changes in the fundus or visual field, ocular inflammation, etc.)
- A subject with an uncontrolled systemic disease: A potential subject in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study
- A subject with diabetes that is poorly controlled
- A subject currently participating or has participated in another clinical trial within 30 days prior to enrollment.
- Intra-Operative Exclusion Criteria (Surgical Complications):
- Sulcus-sulcus or bag-sulcus fixation
- Posterior capsular rupture or zonular dialysis
- Disruption of anterior hyaloids face
- Vitreous loss
- Capsulorhexis tear
- Floppy iris syndrome
- Requirement for the use of trypan blue, capsular tension ring or other intraocular device other than the Intra ocular lens (IOL)
- Inability to place IOL in capsular bag
- Significant anterior chamber hyphema
- Zonular rupture.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Ophthalmic Consultants of Long Island
Garden City, New York, 11530
Erin Loweree, 516-593-4026, eloweree@ocli.net
Isabel Lezcano, 516-593-4026, ilezcano@ocli.net
About this study
Official title: A Prospective Trial Evaluating a Intracanalicular Insert Delivery System Compared to Traditional Topical Drops in Controlling Post-operative Pain and inFlammation in Subjects Undergoing Sequential Bilateral Cataract Surgery
To evaluate the safety and ocular efficacy of Dextenza in combination with an intracameral antibiotic and NSAID in controlling post-operative ocular pain and inflammation compared to standard of care topical therapy in patients undergoing bilateral cataract surgery.
Read the detailed description
This is a randomized, self-controlled prospective clinical study. On initial consultation within one month of scheduled cataract surgery, each study subject will be randomized by a random number generator to receive one of two treatment groups, either experimental or control in the first eye. The second eye will undergo cataract surgery 2 weeks later and will be treated with the other treatment group:
Experimental Group: A total of 50 study subjects (50 eyes) will receive Dextenza dexamethasone intracanalicular insert placed in the lower punctum of their scheduled surgical eye at the time of surgery and will receive intracameral ketorolac during the procedure and 50 micrograms of intracameral moxifloxacin at the conclusion of the procedure.
Control Group: A total of 50 study subjects (50 eyes) will receive topical moxifloxacin 0.5% qid 1 day prior to surgery and for ten days postoperatively, ketorolac 0.5% qid 1 day prior to surgery and for 1 month postoperatively, and prednisolone acetate 1.0% qid starting at the conclusion of cataract surgery for 2 weeks and bid for 2 weeks in their scheduled surgical eye.
- Conditions
- Patient Preference
- Being tested
- Dexamethasone, Standard of care surgery
- Medical subject headings
- Patient Preference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Ketorolac, moxifloxacin
Drugs to be administer during cataract surgery to experimental group
Standard of care surgeryOther
Standard method used for surgery and the use of post operative drops
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | A total of 50 study subjects (50 eyes) will receive Dextenza dexamethasone intracanalicular insert placed in the lower punctum of their scheduled surgical eye at the time of surgery and will receive intracameral ketorolac during the procedure and 50 micrograms of intracameral moxifloxacin at the conclusion of the procedure. Receives: Drug: Dexamethasone |
| Control Group | Active comparator | A total of 50 study subjects (50 eyes) will receive topical moxifloxacin 0.5% qid 1 day prior to surgery and for ten days postoperatively, ketorolac 0.5% qid 1 day prior to surgery and for 1 month postoperatively, and prednisolone acetate 1.0% qid starting at the conclusion of cataract surgery for 2 weeks and bid for 2 weeks in their scheduled surgical eye. Receives: Other: Standard of care surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Preference
Patient preference for medication protocol between the two eyes as assessed by using a standard set of questions
Measured: Day 28 of second eye surgery
Secondary outcomes (7)
Summed Ocular Inflamation Score
Sum of the mean anterior chamber cells and anterior flare score as measured by Slit Lamp Biomicroscopy
Measured: Day 14 each eye
Surgical care
Patient assessment of surgical care quality as measured by the CAHPS survey
Measured: Day 28 of second eye surgery
Post-operative pain
Absence of post-operative ocular pain as measured by ocular pain assessment numerical grading scale 0-10
Measured: Day 7 each eye
Best Corrected Visual Acuity (BCVA)
Mean change in BCVA from baseline
Measured: 2 month / 60 days Visit for second eye
Distance Visual Acuity (VA)
Mean change in Distance VA
Measured: 2 month / 60 days Visit for second eye
Physician evaluation of insertion
Physician ease of intracanalicular insertion evaluation as measured by physician questionnaire
Measured: Post-op Day 1 for experimental group
Adverse Events
Incidence and severity of ocular and systemic Adverse Events
Measured: 2 month / 60 days Visit for second eye
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start4 Nov 2019
- Primary completion30 Jun 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient PreferenceStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Patients undergoing bilateral cataract Surgery
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ophthalmic Consultants of Long Island
- Sponsor type
- University, hospital or other
- Collaborators
- Ocular Therapeutix, Inc.
- Responsible party
- Sponsor
- Investigators
- Eric Donnenfeld, MD, Principal investigator, Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04205916
- Sponsor's protocol ID
- CIMPLIFY
- Acronym
- CIMPLIFY
- Status last verified
- Dec 2019
- First submitted
- 17 Dec 2019
- Last updated
- 20 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Trial Evaluating a Intracanalicular Insert Delivery System Compared to Traditional Topical Drops in Controlling Post-operative Pain and inFlammation in Subjects Undergoing Sequential Bilateral Cataract Surgery
- ClinicalTrials.gov ID
- NCT04205916
- Acronym / sponsor ID
- CIMPLIFY / CIMPLIFY
- Conditions
- Patient Preference
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ophthalmic Consultants of Long IslandUniversity, hospital or other
- Collaborators
- Ocular Therapeutix, Inc.
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 20 Dec 2019 (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.
To evaluate the safety and ocular efficacy of Dextenza in combination with an intracameral antibiotic and NSAID in controlling post-operative ocular pain and inflammation compared to standard of care topical therapy in patients undergoing bilateral cataract surgery.
Detailed description
This is a randomized, self-controlled prospective clinical study. On initial consultation within one month of scheduled cataract surgery, each study subject will be randomized by a random number generator to receive one of two treatment groups, either experimental or control in the first eye. The second eye will undergo cataract surgery 2 weeks later and will be treated with the other treatment group:
Experimental Group: A total of 50 study subjects (50 eyes) will receive Dextenza dexamethasone intracanalicular insert placed in the lower punctum of their scheduled surgical eye at the time of surgery and will receive intracameral ketorolac during the procedure and 50 micrograms of intracameral moxifloxacin at the conclusion of the procedure.
Control Group: A total of 50 study subjects (50 eyes) will receive topical moxifloxacin 0.5% qid 1 day prior to surgery and for ten days postoperatively, ketorolac 0.5% qid 1 day prior to surgery and for 1 month postoperatively, and prednisolone acetate 1.0% qid starting at the conclusion of cataract surgery for 2 weeks and bid for 2 weeks in their scheduled surgical eye.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients undergoing bilateral cataract Surgery
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: DexamethasoneA total of 50 study subjects (50 eyes) will receive Dextenza dexamethasone intracanalicular insert placed in the lower punctum of their scheduled surgical eye at the time of surgery and will receive intracameral ketorolac during the procedure and 50 micrograms of intracameral moxifloxacin at the conclusion of the procedure. |
| Control Group | Active comparator | Other: Standard of care surgeryA total of 50 study subjects (50 eyes) will receive topical moxifloxacin 0.5% qid 1 day prior to surgery and for ten days postoperatively, ketorolac 0.5% qid 1 day prior to surgery and for 1 month postoperatively, and prednisolone acetate 1.0% qid starting at the conclusion of cataract surgery for 2 weeks and bid for 2 weeks in their scheduled surgical eye. |
Who may qualify
- Ages
- 22 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A male or female subject in good general health (as determined by the Investigator), > 22 years of age at the time of the screening visit
- A subject must be willing and able to sign informed consent
- A woman of child-bearing potential must not be pregnant or lactating, must have a negative pregnancy test at screening and must be practicing an adequate method of birth control. Acceptable methods of birth control include intrauterine device (IUD), oral, dermal ("patch"), implant or injected contraceptives; tubal ligation; and barrier methods with spermicide.
- A subject has the availability, willingness and sufficient cognitive awareness to comply with exam procedures and able to return for all scheduled study visits
- A subject with a cataract for which routine phacoemulsification extraction and implantation of an intraocular lens has been planned
Key exclusion criteria (38 listed)
- A subject with a history of complications, adverse events, trauma or disease in the nasolacrimal area, whether or not it was due to punctal plug wear, including but not limited to dacryocystitis, inflammation or canaliculitis in either eye
- A subject with structural lid abnormalities (e.g., ectropion, entropion) in their schedule surgical eye
- A subject with a puncta >0.9 mm prior to dilation in their scheduled surgical eye
- A subject experiencing significant ocular pain or discomfort in either eye at the screening visit or on the day the plug is to be inserted
- A subject with any moderate to severe lid, conjunctival or corneal findings in either eye at the screening visit
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 |
|---|---|---|
| DexamethasoneAlso: Ketorolac, moxifloxacinDrugs to be administer during cataract surgery to experimental group | Drug | Experimental Group |
| Standard of care surgeryStandard method used for surgery and the use of post operative drops | Other | Control Group |
Primary outcome
Patient Preference
Time frame: Day 28 of second eye surgery
Patient preference for medication protocol between the two eyes as assessed by using a standard set of questions
7 secondary outcomes
Summed Ocular Inflamation Score
Time frame: Day 14 each eye
Surgical care
Time frame: Day 28 of second eye surgery
Post-operative pain
Time frame: Day 7 each eye
Best Corrected Visual Acuity (BCVA)
Time frame: 2 month / 60 days Visit for second eye
Distance Visual Acuity (VA)
Time frame: 2 month / 60 days Visit for second eye
Physician evaluation of insertion
Time frame: Post-op Day 1 for experimental group
Adverse Events
Time frame: 2 month / 60 days Visit for second eye
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2019.
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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.
Eric Donnenfeld, MD principal investigator
Physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone in people with Patient Preference, run by Ophthalmic Consultants of Long Island at 1 site in United States.
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 5 inclusion and 38 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: looking for participants now, as of the sponsor's last update on 20 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin Loweree (516-593-4026, eloweree@ocli.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Preference (time frame: Day 28 of second eye surgery). 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 20 Dec 2019.