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

Primary Purpose

Cataract Surgery

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Prednisolone acetate
Sponsored by
Novartis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract Surgery focused on measuring Prednisolone acetate,, efficacy,, cataract,, eye drops,, tolerability,, inflammation

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Primary efficacy parameter was the anterior chamber flare of the operated eye, measured by a KOWA laser cell flare meter.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    September 9, 2005
    Last Updated
    February 28, 2017
    Sponsor
    Novartis
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00170729
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    August 17, 2004 (Actual)
    Primary Completion Date
    February 28, 2005 (Actual)
    Study Completion Date
    February 28, 2005 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Novartis

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cataract Surgery
    Keywords
    Prednisolone acetate,, efficacy,, cataract,, eye drops,, tolerability,, inflammation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    62 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Prednisolone acetate
    Primary Outcome Measure Information:
    Title
    Primary efficacy parameter was the anterior chamber flare of the operated eye, measured by a KOWA laser cell flare meter.
    Secondary Outcome Measure Information:
    Title
    The secondary objectives were to demonstrate that two days treatment with 0.5 % prednisolone acetate eye drops:
    Title
    are superior to vehicle regarding corneal edema and bulbar conjunctival hyperemia,
    Title
    are safe regarding intraocular pressure (IOP), visual acuity and frequency of AEs and SAEs,
    Title
    are well tolerated regarding ocular discomfort.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Novartis Customer Information
    Organizational Affiliation
    Novartis
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

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

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