Clinical trial NCT00134992: A Study to Compare Ocular Safety and Tolerability of Prednisolone Acetate 0.5% Eye Drops Versus Vehicle in Healthy Volunteers
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: Prednisolone acetate
eye drops
tolerability
Healthy volunteers
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-08-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: 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 outcomes:
measure: Tolerability of the trial drug
measure: and the frequency, severity and relationship to study medication of all adverse events occurring during the course of the study.
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Kopfklinik der Ruprechts-Karls- Universität
Study officials:
affiliation: Novartis
name: Novartis Customer Information
role: STUDY_CHAIR
References: