A Study to Compare Ocular Safety and Tolerability of Eye Drops Containing Prednisolone Acetate in Patients With Intraocular Inflammation After Cataract Surgery

• ClinicalTrials.gov Identifier: NCT00170729
• Recruitment Status: Completed
• First Posted: September 15, 2005
• Last Update Posted: March 1, 2017
• Sponsor: Novartis
• Information provided by (Responsible Party): Novartis

Tracking Information

• First Submitted Date: September 9, 2005
• First Posted Date: September 15, 2005
• Last Update Posted Date: March 1, 2017
• Actual Study Start Date: August 17, 2004
• Actual Primary Completion Date: February 28, 2005 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 7, 2006): Primary efficacy parameter was the anterior chamber flare of the operated eye, measured by a KOWA laser cell flare meter.
• Original Primary Outcome Measures: Not Provided

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

• The secondary objectives were to demonstrate that two days treatment with 0.5 % prednisolone acetate eye drops:
• are superior to vehicle regarding corneal edema and bulbar conjunctival hyperemia,
• are safe regarding intraocular pressure (IOP), visual acuity and frequency of AEs and SAEs,
• are well tolerated regarding ocular discomfort.

• 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 Eye Drops Containing Prednisolone Acetate in Patients With Intraocular Inflammation After Cataract Surgery
• Official Title: Multi-center, Randomized, Double Masked, Vehicle Controlled Phase IV Study to Compare the Efficacy, Ocular Safety and Tolerability of a Two Day Treatment With Eye Drops (0.5% Prednisolone Acetate, One Drop Four Times Per Day) in Patients With Intraocular Inflammation After Cataract Surgery, Followed by an Open Label Observational Period of 12 Days
• Brief Summary: The primary objective was to demonstrate that two days of treatment with 0.5% prednisolone acetate eye-drops after cataract surgery are superior to vehicle in reducing the flare in the anterior chamber of the operated eye.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
• Condition: Cataract Surgery
• Intervention: Drug: Prednisolone acetate
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 28, 2017): 62
• Original Enrollment: Not Provided
• Actual Study Completion Date: February 28, 2005
• Actual Primary Completion Date: February 28, 2005 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patient gave written informed consent.
• Patient was > 40 years of age.
• Patient had undergone cataract surgery according to standard surgical procedures (see Appendix 2 to the Protocol).
• Patient showed flare in anterior chamber of ≥ 20 photons/msec on Day 1 as compared to the preoperative value measured at screening
• Patient gave written informed consent.

Exclusion Criteria:

• Ophthalmologic conditions
• Operation not performed according to the standard procedures.
• Any eye condition which urgently requires treatment with NSAIDs or corticosteroids.
• History of intraocular surgery in the operated eye.
• Any laser therapy or cryotherapy in the operated eye in the 90 days preceding surgery.
• Any previous episode of uveitis in the operated eye.
• Clinically significant trichiasis or other clinically relevant concurrent inflammatory/ infective eye disorders (e.g. conjunctivitis, episcleritis) except mild forms of seborrheic blepharitis.
• Severe dry eye syndrome.
• Glaucoma.
• Any other clinically significant disorder of the operated eye.
• Contact lens wearer during the treatment period. Systemic conditions
• Hypersensitivity to any of the ingredients of the trial medication.
• Diabetes mellitus (even if currently controlled).
• Severe systemic dysfunction (cardiac, pulmonary, hepatic, renal or endocrine).
• Rheumatoid arthritis.
• 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 exists, are excluded, with the exception of localized basal cell carcinoma of the skin.

Prohibited concomitant medication

• Treatment of the eye (to be operated on) with local anti-inflammatory drugs during 14 days preceding surgery and during the trial.
• Systemic use of corticosteroids 4 weeks preceding the surgery and during the trial. Inhaled corticosteroids are allowed if stable 4 weeks preceding the trial and during the trial. Topical corticosteroids to treat dermatological diseases are allowed, too.
• Chronic systemic use of NSAIDs 4 weeks prior to the trial and during the trial, but occasional use (≤ 2 times per week) of NSAIDs or OTC painkillers to treat minor conditions was acceptable. Low dose aspirin for cardiovascular prophylaxis was allowed.

Other prohibited conditions

• Pregnant or lactating women or of childbearing potential unless adequate birth control methods were used throughout the study.
• Mentally handicapped subjects.
• Alcohol/drug abuse.
• Concomitant or recent use of any other investigational agents within 3 months prior to study start.
• Patient's repeated participation in this trial.
• 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.
• participation in another clinical study within 4 weeks prior enrolment;
• have 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 exists, are excluded, with the exception of localized basal cell carcinoma of the skin.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT00170729
• Other Study ID Numbers: ULT 491 A DE 01
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Novartis
• Original Responsible Party: Not Provided
• 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: February 2017