Cataract SurgeryPhase 4NCT00170729
A Study to Compare Ocular Safety and Tolerability of Eye Drops Containing Prednisolone Acetate in Patients With Intraocular Inflammation After Cataract Surgery
A Phase 4 study testing Prednisolone acetate in people with Cataract Surgery, run by Novartis.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cataract Surgery
- What is being tested?
- Prednisolone acetate
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 17 Aug 2004to 28 Feb 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 31Show fewer
- 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.
About this study
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
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
- Being tested
- Prednisolone acetate
- Keywords
- Prednisolone acetate,, efficacy,, cataract,, eye drops,, tolerability,, inflammation
- Medical subject headings
- Cataract, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prednisolone acetateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study start17 Aug 2004
- Primary completion28 Feb 2005
- Study completion28 Feb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Customer Information, Study chair, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00170729
- Sponsor's protocol ID
- ULT 491 A DE 01
- Status last verified
- Feb 2017
- First submitted
- 9 Sep 2005
- Last updated
- 1 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00170729
- Acronym / sponsor ID
- ULT 491 A DE 01
- Conditions
- Cataract Surgery
- Keywords
- Prednisolone acetate,, efficacy,, cataract,, eye drops,, tolerability,, inflammation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- 17 Aug 2004 (actual)
- Primary completion
- 28 Feb 2005 (actual)
- Study completion
- 28 Feb 2005 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (31 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prednisolone acetate | Drug | – |
Primary outcome
Primary efficacy parameter was the anterior chamber flare of the operated eye, measured by a KOWA laser cell flare meter.
4 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Customer Information study chair
Novartis
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prednisolone acetate in people with Cataract Surgery, run by Novartis.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary efficacy parameter was the anterior chamber flare of the operated eye, measured by a KOWA laser cell flare meter.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2017.