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Hydrocortisone Ophthalmic Ointment 0.5% for Treatment of Allergic Conjunctivitis

NCT01860664 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2017-08-18

No results posted yet for this study

Summary

The purpose of this study is to determine the safety and effectiveness of hydrocortisone ophthalmic ointment compared to placebo in the treatment of Allergic Conjunctivitis.

Conditions

  • Allergic Conjunctivitis

Interventions

DRUG

hydrocortisone ophthalmic ointment 0.5%

* Patients will be instructed to apply Hydrocortisone Ophthalmic Ointment 0.5% or placebo in the lower cul de sac or lid margin BID * Patients will be instructed to not use the study medications at least 2 hours prior to their appointment. * Study medication dosing details: * 0.05 grams hydrocortisone per gram of combination product * each application equal to 1/20th of a gram * total amount of active ingredient applied to each eye per application = 0.0025 grams hydrocortisone * total amount hydrocortisone applied per eye per day = 0.005 grams hydrocortisone * Total amount of active ingredient applied per eye throughout duration of the two week study = 0.07 grams hydrocortisone

DRUG

placebo

Mineral oil and white petrolatum

Sponsors & Collaborators

  • Fera Pharmaceuticals, LLC

    collaborator UNKNOWN

  • Koffler Vision Group

    lead OTHER

Principal Investigators

  • Paul Karpecki, OD · Clinical Research Director

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2016-05-31
Completion
2017-01-01

Countries

  • United States

Study Locations

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Entities

Drugs

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 NCT01860664 on ClinicalTrials.gov