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

Condition(s) targeted: Healthy

Intervention: Prednisolone acetate (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Customer Information, Study Chair, Affiliation: Novartis

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.

Official title: Single-Center, Randomized, Double Masked, Two-Period Cross-Over, Three Days Per Period, Phase IV Study to Compare Ocular Safety and Tolerability of Prednisolone Acetate 0.5% Eye Drops Versus Vehicle in Healthy Volunteers

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety Study

Primary outcome: Tolerability of the trial drug by evaluating the overall sum-score of the slit lamp examination built by adding up the scores for conjunctival hyperemia, conjunctival edema, palpebral hyperemia, lid edema and corneal edema

Secondary outcome:

Tolerability of the trial drug

and the frequency, severity and relationship to study medication of all adverse events occurring during the course of the study.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Kopfklinik der Ruprechts-Karls- Universität, Heidelberg, Germany

Starting date: August 2004
Last updated: June 7, 2006