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

NCT00170729 | Completed Phase 4

• 1 other identifier: ULT 491 A DE 01
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cataract Surgery

Keywords

Prednisolone acetate,; efficacy,; cataract,; eye drops,; tolerability,; inflammation

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

• 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.

Interventions

Prednisolone acetate DRUG

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis: lead

MeSH Terms

Conditions

Cataract; Inflammation

Interventions

prednisolone acetate

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Novartis Customer Information

  Novartis

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 15, 2005
• Study Start: August 17, 2004
• Primary Completion: February 28, 2005
• Study Completion: February 28, 2005
• Last Updated: March 1, 2017

Record last verified: 2017-02