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Prophylactic Treatment: Lessdrops™ vs Standard Drops Regimen

NCT03578276 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2022-06-10

Study results available
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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.

Conditions

  • Cataract

Interventions

DRUG

Pred-Gati-Brom

The combination drop therapy containing prednisolone acetate 1%, gatifloxacin 0.5%, and bromfenac 0.075%

DRUG

Prednisolone acetate 1% ophthalmic suspension

Steroidal anti-inflammatory

DRUG

Gatifloxacin Ophthalmic

Antibiotic

DRUG

Bromfenac 0.075% Oph Solution

Non-steroidal anti-inflammatory

Sponsors & Collaborators

  • Science in Vision

    collaborator OTHER

  • Imprimis Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Carolina Eyecare Physicians, LLC

    lead OTHER

Principal Investigators

  • Kerry Solomon, MD · Carolina Eyecare Physicians, LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-22
Primary Completion
2019-12-04
Completion
2019-12-04
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03578276 on ClinicalTrials.gov