Prophylactic Treatment: Lessdrops™ vs Standard Drops Regimen

• Status: Completed
• Trial end date: 2019-12-04
• Target enrollment: 0
• Participant gender: All

Summary

To compare the use of a compounded eye drop containing an antibiotic, a non-steroidal and steroidal anti-inflammatory to standard of care that is the use of 3 different topical medications to prevent inflammation and infection after routine cataract surgery.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Carolina Eyecare Physicians, LLC
• Collaborators: Imprimis Pharmaceuticals, Inc.; Science in Vision
• Treatments: Anti-Inflammatory Agents; Bromfenac; Fluoroquinolones; Gatifloxacin; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• Subject is undergoing bilateral cataract extraction or refractive lens exchange with intraocular lens implantation.

• 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 with topical anesthesia in both eyes within 6-15 days between surgeries.

• Potential postoperative best-corrected visual acuity of 20/30 or better.

Exclusion Criteria:

• 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, advanced macular degeneration, advanced glaucomatous damage, etc.

• 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/noninfectious 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.

• Any additional ocular surgical procedures at time of cataract extraction (i.e. iStent) except corneal incisions for the correction of astigmatism.

• Anesthesia other than topical 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 ophthalmic 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.