Ignite Creation Date:
2024-05-06 @ 12:47 AM
Last Modification Date:
2024-10-26 @ 10:54 AM
Study NCT ID:
NCT01655758
Status:
COMPLETED
Last Update Posted:
2012-08-02
First Post:
2012-07-21
Brief Title:
24-hour Control of Intraocular Pressure IOP in Ocular Hypertension
Sponsor:
University of Parma
Organization:
University of Parma
Study Overview
Official Title:
The 24 Control of IOP in Ocular Hypertension a Cross-over Study on Inflow Versus Outflow Drugs
Status:
COMPLETED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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 05 bid 60 days washout 60 days timolol 05-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 ie active treatment and washoute 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 am 11 am 3 pm 6 pm and 9 pm by means of Goldmann applanation tonometry at the slit lamp At midnight 2 am and 6 am 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 25 mmHg with an estimated pooled variance 4 a power 90 and an alpha probability 5
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None