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A Trial Evaluating Patient Preference of Dropless vs Drops Post Cataract Surgery (CIMPLIFY)

Primary Purpose

Patient Preference

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone
Standard of care surgery
Sponsored by
Ophthalmic Consultants of Long Island
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Patient Preference

Eligibility Criteria

22 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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.

Sites / Locations

  • Ophthalmic Consultants of Long IslandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Patient Preference
Patient preference for medication protocol between the two eyes as assessed by using a standard set of questions

Secondary Outcome Measures

Summed Ocular Inflamation Score
Sum of the mean anterior chamber cells and anterior flare score as measured by Slit Lamp Biomicroscopy
Surgical care
Patient assessment of surgical care quality as measured by the CAHPS survey
Post-operative pain
Absence of post-operative ocular pain as measured by ocular pain assessment numerical grading scale 0-10
Best Corrected Visual Acuity (BCVA)
Mean change in BCVA from baseline
Distance Visual Acuity (VA)
Mean change in Distance VA
Physician evaluation of insertion
Physician ease of intracanalicular insertion evaluation as measured by physician questionnaire
Adverse Events
Incidence and severity of ocular and systemic Adverse Events

Full Information

First Posted
December 17, 2019
Last Updated
December 17, 2019
Sponsor
Ophthalmic Consultants of Long Island
Collaborators
Ocular Therapeutix, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04205916
Brief Title
A Trial Evaluating Patient Preference of Dropless vs Drops Post Cataract Surgery
Acronym
CIMPLIFY
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Recruiting
Study Start Date
November 4, 2019 (Actual)
Primary Completion Date
June 30, 2020 (Anticipated)
Study Completion Date
December 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ophthalmic Consultants of Long Island
Collaborators
Ocular Therapeutix, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patient Preference

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Patients undergoing bilateral cataract Surgery
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Ketorolac, moxifloxacin
Intervention Description
Drugs to be administer during cataract surgery to experimental group
Intervention Type
Other
Intervention Name(s)
Standard of care surgery
Intervention Description
Standard method used for surgery and the use of post operative drops
Primary Outcome Measure Information:
Title
Patient Preference
Description
Patient preference for medication protocol between the two eyes as assessed by using a standard set of questions
Time Frame
Day 28 of second eye surgery
Secondary Outcome Measure Information:
Title
Summed Ocular Inflamation Score
Description
Sum of the mean anterior chamber cells and anterior flare score as measured by Slit Lamp Biomicroscopy
Time Frame
Day 14 each eye
Title
Surgical care
Description
Patient assessment of surgical care quality as measured by the CAHPS survey
Time Frame
Day 28 of second eye surgery
Title
Post-operative pain
Description
Absence of post-operative ocular pain as measured by ocular pain assessment numerical grading scale 0-10
Time Frame
Day 7 each eye
Title
Best Corrected Visual Acuity (BCVA)
Description
Mean change in BCVA from baseline
Time Frame
2 month / 60 days Visit for second eye
Title
Distance Visual Acuity (VA)
Description
Mean change in Distance VA
Time Frame
2 month / 60 days Visit for second eye
Title
Physician evaluation of insertion
Description
Physician ease of intracanalicular insertion evaluation as measured by physician questionnaire
Time Frame
Post-op Day 1 for experimental group
Title
Adverse Events
Description
Incidence and severity of ocular and systemic Adverse Events
Time Frame
2 month / 60 days Visit for second eye

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erin Loweree
Phone
516-593-4026
Email
eloweree@ocli.net
First Name & Middle Initial & Last Name or Official Title & Degree
Isabel Lezcano
Phone
516-593-4026
Email
ilezcano@ocli.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Donnenfeld, MD
Organizational Affiliation
Physician
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ophthalmic Consultants of Long Island
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erin Loweree
Phone
516-593-4026
Email
eloweree@ocli.net
First Name & Middle Initial & Last Name & Degree
Isabel Lezcano
Phone
516-593-4026
Email
ilezcano@ocli.net
First Name & Middle Initial & Last Name & Degree
Eric Donnenfeld

12. IPD Sharing Statement

Learn more about this trial

A Trial Evaluating Patient Preference of Dropless vs Drops Post Cataract Surgery

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