Prophylactic Treatment: Lessdrops™ vs Standard Drops Regimen
Condition: Cataract
MeSH terms: Cataract
Intervention: Pred-Gati-Brom; Prednisolone acetate 1% ophthalmic suspension; Gatifloxacin Ophthalmic; Bromfenac 0.075% Oph Solution
Intervention description: The combination drop therapy containing prednisolone acetate 1%, gatifloxacin 0.5%, and bromfenac 0.075%; Steroidal anti-inflammatory; Antibiotic; Non-steroidal anti-inflammatory
Intervention MeSH terms: Gatifloxacin; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Bromfenac; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants' eyes are assigned to one of two groups.
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 50 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: cataract surgery; Prophylaxis

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.
    

Eligibility 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.