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

NCT04205916 | Recruiting Phase 4 FDA Drug

• 1 other identifier: CIMPLIFY
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient Preference

Outcome Measures

Primary Outcomes (1)

• Patient Preference

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

  Day 28 of second eye surgery

Secondary Outcomes (7)

• Summed Ocular Inflamation Score

  Day 14 each eye

• Surgical care

  Day 28 of second eye surgery

• Post-operative pain

  Day 7 each eye

• Best Corrected Visual Acuity (BCVA)

  2 month / 60 days Visit for second eye

• Distance Visual Acuity (VA)

  2 month / 60 days Visit for second eye

Study Arms (2)

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.

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.

Other: Standard of care surgery

Interventions

Dexamethasone DRUG

Drugs to be administer during cataract surgery to experimental group

Also known as: Ketorolac, moxifloxacin

Experimental Group

Standard of care surgery OTHER

Standard method used for surgery and the use of post operative drops

Control Group

Eligibility Criteria

• Age: 22 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ophthalmic Consultants of Long Island: lead
• Ocular Therapeutix, Inc.: collaborator

Study Sites (1)

Ophthalmic Consultants of Long Island

Garden City, New York, 11530, United States

RECRUITING

MeSH Terms

Conditions

Patient Preference

Interventions

Dexamethasone; Ketorolac; Moxifloxacin

Condition Hierarchy (Ancestors)

Patient Satisfaction; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines

Study Officials

• Eric Donnenfeld, MD

  Physician

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin Loweree

CONTACT

516-593-4026; eloweree@ocli.net

Isabel Lezcano

CONTACT

516-593-4026; ilezcano@ocli.net

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients undergoing bilateral cataract Surgery

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: December 20, 2019
• Study Start: November 4, 2019
• Primary Completion: June 30, 2020
• Study Completion: December 1, 2020
• Last Updated: December 20, 2019

Record last verified: 2019-12

Locations

US (1)