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

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ClinicalTrials.gov Identifier: NCT00134992
Recruitment Status : Completed
First Posted : August 25, 2005
Last Update Posted : June 9, 2006
Sponsor:
Information provided by:
Novartis

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Prednisolone acetate Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
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
Study Start Date : August 2004





Primary Outcome Measures :
  1. 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 :
  1. Tolerability of the trial drug
  2. and the frequency, severity and relationship to study medication of all adverse events occurring during the course of the study.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00134992


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

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ClinicalTrials.gov Identifier: NCT00134992     History of Changes
Other Study ID Numbers: CULT 491 DE 02
First Posted: August 25, 2005    Key Record Dates
Last Update Posted: June 9, 2006
Last Verified: June 2006

Keywords provided by Novartis:
Prednisolone acetate
eye drops
tolerability
Healthy volunteers

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