Dropless™ vs. Less Drops™ Pharmaceutical Regimens After Cataract Surgery

NCT02819908 | Completed Phase 4 Results

• 1 other identifier: BF-2015-011
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the relative effectiveness of the Imprimis Dropless™ (TriMoxiVanc) intraocular solution with the Less Drops™ topical formulation of PredMoxiKeterolac (given for the first week post op) followed by PredKeterolac (given for weeks 2 to 4 after surgery). The hypothesis is that the "dropless" regimen will be non-inferior to the "less drops" regimen in terms of post-operative IOP changes, post-operative healing, and visual quality.

Conditions

Intraocular Lens Associated Postoperative Inflammation

Outcome Measures

Primary Outcomes (1)

• The Change in Intraocular Pressure (IOP) From Baseline

  Based on Goldmann tonometry

  To end of study (1 month postop)

Secondary Outcomes (2)

• Change in Corneal Thickness

  To end of study (1 month postop)

• Slit Lamp (Cornea Exam)

  To end of study (1 month postop)

Other Outcomes (6)

• Subject Reporting no Eye Pain

  To end of study (1 month postop)

• Change From Baseline Eye Pain/Discomfort

  To end of study (1 month postop)

• The Proportion of Subjects Reporting no Visual Symptoms ("0" )

  To end of study (1 month postop)

Study Arms (2)

Imprimis Dropless

ACTIVE COMPARATOR

TriMoxiVanc 0.2cc intravitreal one time

Drug: Imprimis Dropless

Imprimis Less Drops

ACTIVE COMPARATOR

Pred Moxi, 1 drop tid for 1 week then, PredKeterolac bid for 2-4 weeks.

Drug: Imprimis Less Drops

Interventions

Imprimis Dropless DRUG

Tri-Moxi-Vanc transzonular intravitreal injection

Imprimis Dropless

Imprimis Less Drops DRUG

Pred-Moxi-Ketorolac and Pred-Ketorolac topical instillation qd postoperatively

Imprimis Less Drops

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ocular criteria must be met in both eyes.
• Subject is undergoing bilateral cataract extraction or refractive lens exchange with intraocular lens implantation.
• Gender: Males and Females.
• Age: 21 or older.
• Willing and able to provide written informed consent for participation in the study.
• Willing and able to comply with scheduled visits and other study procedures.
• Willing and able to administer eye drops and record the times the drops were instilled.
• Scheduled to undergo standard cataract surgery or refractive lens exchange with topical anesthesia in both eyes within 6-15 days of each other.
• Potential postoperative best-corrected visual acuity of 20/30 or better.

You may not qualify if:

• Severe preoperative ocular pathology: amblyopia, rubella cataract, proliferative diabetic retinopathy, shallow anterior chamber, macular edema, aniridia or iris atrophy, uveitis, history of iritis, iris neovascularization, medically uncontrolled glaucoma, microphthalmos or macrophthalmos, optic nerve atrophy, macular degeneration (with anticipated best postoperative visual acuity less than 20/30), advanced glaucomatous damage, etc.
• Presence of epiretinal membrane.
• Uncontrolled diabetes.
• Use of any systemic or topical drug known to interfere with visual performance.
• Contact lens use during the active treatment portion of the trial.
• Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis.
• History of chronic intraocular inflammation.
• History of retinal detachment.
• Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules.
• Previous refractive surgery.
• Anesthesia other than topical, oral or intravenous anesthesia (i.e. retrobulbar, general, etc).
• Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or may interfere with the interpretation of study results.
• Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial.
• Intraocular conventional surgery within the past three months or intraocular laser surgery within one month.
• The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.

Sponsors & Collaborators

• Eye Center of North Florida: lead

Study Sites (1)

Eye Center of North Florida

Panama City, Florida, 32409, United States

Location

Limitations and Caveats

Study data has been lost to natural disaster (Hurricane Micheal), therefore there is no study data that is available to report

Results Point of Contact

• Title: Christina Menck
• Organization: Eye Center of N Florida

eyenerdgyrl1@gmail.com

8507843937

Study Officials

• Bret L Fisher, MD

  Eye Center of North Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 2, 2015
• First Posted: June 30, 2016
• Study Start: September 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: March 9, 2020
• Results First Posted: March 9, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)