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

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: August 24, 2005
Last updated: June 7, 2006
Last verified: June 2006
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.

Condition Intervention Phase
Drug: Prednisolone acetate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 Measures:
  • 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.

Estimated Enrollment: 30
Study Start Date: August 2004

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00134992

Kopfklinik der Ruprechts-Karls- Universität
Heidelberg, Germany
Sponsors and Collaborators
Study Chair: Novartis Customer Information Novartis
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00134992     History of Changes
Other Study ID Numbers: CULT 491 DE 02 
Study First Received: August 24, 2005
Last Updated: June 7, 2006
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Prednisolone acetate
eye drops
Healthy volunteers

Additional relevant MeSH terms:
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Ophthalmic Solutions
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Peripheral Nervous System Agents
Pharmaceutical Solutions
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 10, 2016