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Evaluation of Prednisolone in a Modified Conjunctival Allergen Challenge Model

NCT01730872 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2019-06-19

Study results available
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Summary

The purpose of this study is to evaluate the effectiveness of the modified Conjunctival Allergen Challenge (CAC) and observe how the produced allergic inflammation reacts to treatment with a proven ocular anti-inflammatory medication,

Prednisolone, assessed by the following measures:

Chronic Allergic Inflammation assessed using confocal microscopy Ocular itching Conjunctival redness

Conditions

  • Chronic Allergic Conjunctivitis

Interventions

DRUG

Prednisolone Sodium Phosphate Ophthalmic Solution 1%

One drop in each eye, four times/day for 4 days.

DRUG

Tears Naturale II Ophthalmic Solution

one drop in each eye, four times/ day (QID) for 4 days

Sponsors & Collaborators

  • ORA, Inc.

    lead INDUSTRY

Principal Investigators

  • Gail Torkildsen, MD · Massachusetts Medical Society, Alpha Omega Alpha Honor Society, American Academy of Ophthalmology

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2012-12-31
Completion
2012-12-31

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 NCT01730872 on ClinicalTrials.gov