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

Sponsor

Novartis (Industry)

Overall Status

Completed

CT.gov ID

NCT00170729

Collaborator

(none)

Enrollment

6.4

Actual Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract Surgery	Drug: Prednisolone acetate	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

62 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

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

Actual Study Start Date :

Aug 17, 2004

Actual Primary Completion Date :

Feb 28, 2005

Actual Study Completion Date :

Feb 28, 2005

Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts 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.