A Trial Evaluating Patient Preference of Dropless vs Drops Post Cataract Surgery
NCT ID: NCT04205916
Last Updated: 2019-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
50 participants
INTERVENTIONAL
2019-11-04
2020-12-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
SINGLE_GROUP
OTHER
NONE
Study Groups
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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.
Dexamethasone
Drugs to be administer during cataract surgery to experimental group
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.
Standard of care surgery
Standard method used for surgery and the use of post operative drops
Interventions
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Dexamethasone
Drugs to be administer during cataract surgery to experimental group
Standard of care surgery
Standard method used for surgery and the use of post operative drops
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
* 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.
22 Years
100 Years
ALL
Yes
Sponsors
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Ocular Therapeutix, Inc.
INDUSTRY
Ophthalmic Consultants of Long Island
OTHER
Responsible Party
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Principal Investigators
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Eric Donnenfeld, MD
Role: PRINCIPAL_INVESTIGATOR
Physician
Locations
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Ophthalmic Consultants of Long Island
Garden City, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Erin Loweree
Role: primary
Isabel Lezcano
Role: backup
Other Identifiers
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CIMPLIFY
Identifier Type: -
Identifier Source: org_study_id