A Study to Compare Ocular Safety and Tolerability of Prednisolone Acetate 0.5% Eye Drops Versus Vehicle in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Brief Summary

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The objective of this trial was to confirm the tolerability of prednisolone acetate 0.5% eye drops by testing the hypothesis that the ocular safety and tolerability of prednisolone acetate 0.5% eye drops are equivalent to vehicle. Thus healthy volunteers have been selected and have been treated by using a crossover design.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Prednisolone acetate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy subjects of either gender, 18 years or older, who were able to give an informed consent
* A score for ocular discomfort of 0-20 mm on the visual analogue scale (VAS) prior to treatment

Exclusion Criteria

* Known hypersensitivity to any of the constituents of the medications
* Known corticosteroid responder (elevation of intraocular pressure \[IOP\])
* Known allergic disposition (e.g. hay fever)
* Need of ocular antiallergic treatment
* Wearing of contact lenses
* Any kind of current eye disease (e.g. dry eye)
* Any kind of concomitant ocular treatment
* Any injury or infection in either eye during the last 3 months prior to the first application
* Any medication taken within the last 28 days prior to the first application, except hormonal contraceptives
* Concomitant or previous treatment with antihistamines within a week prior to enrolment
* Pregnant or breast feeding women
* Participation in another clinical study within 4 weeks prior to enrolment
* Hematological diseases such as aplastic anemia, panmyelopathy, or hemolytic icterus; with severe dysfunction of the liver.
* Any medical or laboratory condition which, in the Investigator's opinion, would preclude the participant from adhering to the protocol or completing the trial per protocol
* Subjects with history of malignancy of any organ system, treated or untreated, within the past five years, whether or not evidence of local recurrence or metastases exist, are excluded, with the exception of localized basal cell carcinoma of the skin

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Novartis Customer Information

Role: STUDY_CHAIR

Novartis

Locations

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Kopfklinik der Ruprechts-Karls- Universität

Heidelberg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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CULT 491 DE 02

Identifier Type: -

Identifier Source: org_study_id