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

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

Tracking Information

• First Submitted Date: August 24, 2005
• First Posted Date: August 25, 2005
• Last Update Posted Date: June 9, 2006
• Study Start Date: August 2004
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: June 7, 2006): 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
• Original Primary Outcome Measures: Not Provided

Current Secondary Outcome Measures (submitted: June 7, 2006)

• 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.

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double; Primary Purpose: Treatment
• Condition: Healthy
• Intervention: Drug: Prednisolone acetate
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: June 7, 2006): 30
• Original Enrollment: Not Provided
• Study Completion Date: Not Provided
• Primary Completion Date: Not Provided

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT00134992
• Other Study ID Numbers: CULT 491 DE 02
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Not Provided
• Original Responsible Party: Same as current
• Current Study Sponsor: Novartis
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Novartis Customer Information; Novartis

• PRS Account: Novartis
• Verification Date: June 2006