- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01655758
24-hour Control of Intraocular Pressure (IOP) in Ocular Hypertension
August 1, 2012 updated by: Stefano Gandolfi, University of Parma
The 24 Control of IOP in Ocular Hypertension: a Cross-over Study on Inflow Versus Outflow Drugs.
This study was designed to compare the 24-hour efficacy on intra ocular pressure (IOP) of drugs acting either on aqueous humor production ("inflow drugs") or on aqueous humor outflow ("outflow drugs") in human eyes affected by ocular hypertension and virgin to treatment.
The enrolled patients will be exposed, in a cross-over design, to n = 2 aqueous suppressants and n= 3 uveoscleral outflow enhancers, and 24 hr IOP will be measured.
It is hypothesised that outflow drugs may offer a better and more stable control of IOP through the 24 hours.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
(a) study design: Prospective, open label, investigator-masked clinical trial, with cross-over design, both eyes treated, OD chosen for analysis; (b) study population: patients, showing ocular hypertension, who were never exposed to hypotensive treatment (see inclusion and exclusion criteria for details).
(c) study drugs: Timolol and dorzolamide will be chosen as inflow drugs.
The three prostaglandin analogues (PGA) Latanoprost, travoprost and bimatoprost will be chosen as outflow drugs.
(d) study flow-chart: upon enrollment, patients will be initiated to the following schedule: 60 days timolol 0.5% bid, 60 days washout, 60 days timolol 0.5%-dorzolamide 2% fixed combination bid, 60 days washout, 60 days PGA1, 60 days washout, 60 days PGA2, 60 days washout, 60 days PGA3.
Patients were assigned to the PGAs according to a sequence (L-T-B) randomly generated.
Data will be collected at baseline and at the and of each study phase (i.e.
active treatment and washout)(e) main efficacy outcome: change in the mean IOP (with respect to baseline) at the end of each study phase and change of IOP (with respect to baseline) at the different time points of the 24-hour phasing.
IOP will be measured at 8 a.m., 11 a.m., 3 p.m., 6 p.m. and 9 p.m. by means of Goldmann applanation tonometry at the slit lamp.
At midnight, 2 a.m. and 6 a.m. the Tonopen in supine position will be used.
(f) statistics: the analysis of co-variance (ANCOVA) for paired samples with Bonferroni correction will be adopted.
A minimum sample size of 51 patients is needed for a minimal expected difference in mean IOP between inflow and outflow drugs = 2.5 mmHg, with an estimated pooled variance = 4 , a power = 90% and an alpha probability = 5%.
Study Type
Interventional
Enrollment (Actual)
61
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Parma, Italy, 43100
- University Eye Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- IOP > 22 mmHg and < 30 mmHg on at least three readings on separate days ,
- Open angle on gonioscopy,
- CCT > 550 m,
- optic disk classified as "within normal limits" by Moorfields Regression analysis, HRTII,
- normal visual field (standard achromatic perimetry, Humphrey Field Analyzer, 24/2 SITA standard),
- Age > 40 and < 70 years,
- refraction between - 5 and + 2 dyopters,
- best corrected visual acuity better than 0.2 LogMAR,
Exclusion Criteria:
- PEX
- PDS
- ocular comorbidiities other than refractive problems and/or mild dry eye
- history of diabetes
- treatment with systemic beta blockers and steroids
- previous treatment with ocular hypotensive drugs
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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ACTIVE_COMPARATOR: timolol
60-day treatment phase with 0.5% timolol eyedrops, b.i.d.
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Other Names:
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ACTIVE_COMPARATOR: 'timolol-dorzolamide fixed combination'
60-day treatment phase with the fixed combination of 0.5% timolol-2% dorzolamide, eyedrops, b.i.d.
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Other Names:
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ACTIVE_COMPARATOR: xalatan
60-day treatment phase with 0.005% latanoprost, eyedrops, QD
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Other Names:
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ACTIVE_COMPARATOR: travatan
60-day treatment phase with 0.004% travoprost, eyedrops, QD
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Other Names:
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ACTIVE_COMPARATOR: lumigan
60-day treatment phase with 0.03% bimatoprost, eyedrops, QD
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in the mean IOP at the end of each phase vs baseline, and change of IOP at the different time points of the 24-hour phasing with respect to baseline
Time Frame: IOP will be measured, at baseline, on day 60, 120, 180, 240, 300, 360,420,480 and 540, at 8 a.m., 11 a.m., 3 p.m., 6 p.m., 9 p.m., midnight, 2 a.m. and 6 a.m.
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Goldmann Applanation tonometry (GAT): 2 readings averaged. If >2 mmHg difference between the two, a further reading will be performed. GAT will be adopted during the day, and performed at the slit lamp in sitting position. Tonopen: 4 readings averaged. Tonopen will be used during the night, and the measurements will be perfomred on patients laying in bed in supine position. |
IOP will be measured, at baseline, on day 60, 120, 180, 240, 300, 360,420,480 and 540, at 8 a.m., 11 a.m., 3 p.m., 6 p.m., 9 p.m., midnight, 2 a.m. and 6 a.m.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
visual field
Time Frame: visual field (24/2 SITA) will be performed at screening and at the end of the study (i.e. upon completion of the last cross-over arm, 540 days after baseline)
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Humphrey Field Analyzer, 24/2 SITA standard
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visual field (24/2 SITA) will be performed at screening and at the end of the study (i.e. upon completion of the last cross-over arm, 540 days after baseline)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2002
Primary Completion (ACTUAL)
December 1, 2003
Study Completion (ACTUAL)
February 1, 2004
Study Registration Dates
First Submitted
July 21, 2012
First Submitted That Met QC Criteria
August 1, 2012
First Posted (ESTIMATE)
August 2, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
August 2, 2012
Last Update Submitted That Met QC Criteria
August 1, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Eye Diseases
- Glaucoma
- Ocular Hypertension
- Hypertension
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Enzyme Inhibitors
- Carbonic Anhydrase Inhibitors
- Pharmaceutical Solutions
- Ophthalmic Solutions
- Timolol
- Dorzolamide
- Travoprost
- Bimatoprost
- Latanoprost
Other Study ID Numbers
- UParma2004crossover
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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