Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00440336
Status:
UNKNOWN
Last Update Posted:
2007-03-01
First Post:
2007-02-24
Brief Title:
Comparison of Efficacy of Two Groups of Glaucoma Drops Xalatan vsCosopt in Reducing Eye Pressure Following Laser SLTTreatment in the Management of Glaucoma
Sponsor:
Advanced Glaucoma Specialists
Organization:
Advanced Glaucoma Specialists
Study Overview
Official Title:
Comparison of Efficacy of Prostaglandin Analogues Xalatan and Aqueous Suppressants Cosopt in Reducing Intraocular Pressure Following Selective Laser Trabeculoplasty in the Management of Open-Angle Glaucoma
Status:
UNKNOWN
Status Verified Date:
2007-02
Last Known Status:
RECRUITING
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:
WHAT IS THIS STUDY ABOUT Glaucoma and ocular hypertension are chronic eye diseases that can damage the optic nerve and lead to vision loss or blindness The optic nerve acts like an electric cable with over a million wires This nerve is responsible for carrying images from the eye to the brain The way glaucoma and ocular hypertension cause blindness depends on many factors but the most important factor is the increased pressure inside the eye intraocular pressure
There is no cure for glaucoma or ocular hypertension However lowering the pressure inside the eye has been shown to slow the progression of disease Intraocular pressure can be lowered by glaucoma medication laser treatment or surgery
You have open angle glaucoma pseudoexfoliative glaucoma or ocular hypertension Researchers want to find out more about how 2 drugs called Cosopt dorzolamide hydrochloride and timolol maleate and Xalatan latanoprost can help people with these conditions
Cosopt and Xalatan are both eye drops that are approved by the US Food and Drug Administration FDA to reduce intraocular pressure in people with open angle glaucoma and ocular hypertension
The study doctor will do a laser procedure called Selective Laser Trabeculoplasty SLT on people in this study to help lower their intraocular pressure The FDA has approved SLT to treat open angle glaucoma and ocular hypertension
Then the study doctor will ask some participants to use either Cosopt or Xalatan if their intraocular pressure is still too high 4 to 6 weeks after the SLT procedure The study doctor wants to see which of the 2 study drugs Cosopt or Xalatan is better at reducing intraocular pressure after SLT
It is planned that about 30 people with glaucoma or ocular hypertension who are at least 18 years old will be in this study Out of the participants whose intraocular pressure is still too high after SLT half will use Cosopt and half will use Xalatan You do not have to be in this study to have SLT or to use Cosopt or Xalatan
There is no cure for glaucoma or ocular hypertension However lowering the pressure inside the eye has been shown to slow the progression of disease Intraocular pressure can be lowered by glaucoma medication laser treatment or surgery
You have open angle glaucoma pseudoexfoliative glaucoma or ocular hypertension Researchers want to find out more about how 2 drugs called Cosopt dorzolamide hydrochloride and timolol maleate and Xalatan latanoprost can help people with these conditions
Cosopt and Xalatan are both eye drops that are approved by the US Food and Drug Administration FDA to reduce intraocular pressure in people with open angle glaucoma and ocular hypertension
The study doctor will do a laser procedure called Selective Laser Trabeculoplasty SLT on people in this study to help lower their intraocular pressure The FDA has approved SLT to treat open angle glaucoma and ocular hypertension
Then the study doctor will ask some participants to use either Cosopt or Xalatan if their intraocular pressure is still too high 4 to 6 weeks after the SLT procedure The study doctor wants to see which of the 2 study drugs Cosopt or Xalatan is better at reducing intraocular pressure after SLT
It is planned that about 30 people with glaucoma or ocular hypertension who are at least 18 years old will be in this study Out of the participants whose intraocular pressure is still too high after SLT half will use Cosopt and half will use Xalatan You do not have to be in this study to have SLT or to use Cosopt or Xalatan
Detailed Description:
Introduction Selective Laser Trabeculoplasty has been shown as a relatively safe and effective treatment modality for lowering IOP in various forms of open-angle glaucoma Latina et al It lowers IOP by increasing aqueous outflow through its effect at cellular level possibly either 1 through migration and phagocytosis of trabecular meshwork debris by macrophages or 2 by stimulating the proliferation of healthy trabecular and endothelial cells
Cases who dont achieve target IOP following SLT therapy need additional treatment in form of topical medications Conventionally common topical antiglaucoma medications to treat glaucoma after SLT therapy either suppress aqueous secretion B-blockers or carbonic anhydrase inhibitors or enhances uveoscleral aqueous outflow Prostaglandin analogues Since Selective Laser Trabeculoplasty acts on outflow pathway further additional IOP reduction can be achieved more effectively by a class of drug which acts on different pathway on aqueous secretion by aqueous suppressants like Cosopt In contrast drugs acting on outflow pathway like prostaglandin analogue Xalatan etc will possibly be less additive in further reducing IOP after SLT since SLT also has effect on the same pathway- outflow pathway
Previous studies Fechtner et al J Ocul Pharmacol Ther 2005 Jun213242-9 and Fechtner et al Acta Ophthalmol Scand 2004 Feb82142-8 have shown equal efficacy of Cosopt and Latanoprost in reducing IOP in treatment of glaucoma But to our knowledge no long term prospective study has evaluated aqueous suppressants Cosopt and prostaglandin analogues with respect to their comparative efficacy in treatment of uncontrolled glaucoma status post SLT therapy
OBJECTIVE The primary objective of this study is to compare the IOP lowering efficacy of aqueous suppressants Cosopt and prostaglandin analogues Xalatan when used status post SLT in the management of Open Angle Glaucoma or Ocular Hypertension
INCLUSION CRITERIA 1 Adult subjects of either sex of any race eighteen years of age or older 2 Diagnosis Primary Open Angle Glaucoma Pseudoexfoliation Glaucoma Ocular Hypertension
3 Mild to moderate glaucoma only Pattern standard deviation PSD more than 1DB and less than 6 DB on Humphrey Visual Field
3 Subject may be
A newly diagnosed glaucoma or
A pre-existing glaucoma on not more than two topical antiglaucoma medications 3 On no systemic medications known to increase IOP eg steroids 4 Visual acuity equal or better than 20200 in the study eye 5 IOP less than 35 mm Hg in the study eye 6 No previous intraocular surgery within last 6 months except laser PI greater than 3 months ago
EXCLUSION CRITERIA Pigmentary OAG Proliferative diabetic retinopathy History of chronic or recurrent severe inflammatory eye disease ie scleritis uveitis herpes keratitis known allergy to COSOPT or any of Prostaglandin Analogues Chronic Obstructive Airways Disease COPD sinus bradycardia heart rate 60 beats per minute second or third-degree atrioventricular block overt cardiac failure Pregnant and nursing mothers
STUDY DESIGN Single site unmasked prospective randomized study STUDY PROCEDURE
Visit 1 Visit 2 Visit 3 Visit 4 Visit 5 Visit 6 Screening Phase SLT Treatment Phase Safety check 2 weeks after SLT RANDOMIZATION 4 to 6 weeks after SLT Follow up visit 6 weeks after randomization Last Visit 3 months after randomization Determine eligibility by doing routine eye exam including IOP check by Goldmann applanation tonometer Gonioscopy fundus exam Humphrey Visual Field if HVF not done within last 6 months
Subjects who fulfill the eligibility criteria and give consent for participating in study will be scheduled for SLT All eligible subjects will receive SLT Pre-existing glaucoma cases already on antiglaucoma medications will discontinue all the antiglaucoma medications since the day of SLT treatment and will be off the drops for next 4 to 6 weeks Similarly newly diagnosed glaucoma will not be on any antiglaucoma medications for next 4 to 6 weeks Each subject will have IOP check at 2 weeks after SLT treatment It will be done to rule out any unusual IOP spike following SLT Each subject will have routine eye exam including IOP check at this visit The subjects with uncontrolled IOP despite SLT therapy will be randomized to receive either COSOPT or Prostaglandin analogue XALATAN IOP check and routine eye exam IOP check routine eye exam including fundus exam and Humphrey Visual Field
If IOP is uncontrolled at the visit 5 a stepped drug therapy will be initiated based on following protocol
1 For patients who are in Cosopt group after randomization Sequence of additional medications will be following
First Step Alphagan Brimonidine Second Step Prostaglandin Analogues
2 For patients who are in Xalatan group after randomization Sequence of additional medications will be following
First Step Alphagan Brimonidine Second Step Dorzolamide Trusopt
Note IOP will be measured using a Goldmann Applanation Tonometer at 8 AM and 10 AM at visits Visit I Visit IV Visit V and Visit VI A 30 minute window will be allowed for each measurement recording
IOP measurement at Visit II SLT treatment phase and Visit III safety check can be done at random time
Duration of Study Participation Subjects who are eligible to participate in the study shall be enrolled for approximately 6 months References Fechtner RD McCarroll KA Lines CR Adamsons IA Efficacy of the dorzolamidetimolol fixed combination versus latanoprost in the treatment of ocular hypertension or glaucoma combined analysis of pooled data from two large randomized observer and patient-masked studiesJ Ocul Pharmacol Ther 2005 Jun213242-9 Fechtner RD Airaksinen PJ Getson AJ Lines CR Adamsons IA COSOPT versus XALATAN Study Groups
Efficacy and tolerability of the dorzolamide 2timolol 05 combination COSOPT versus 0005 XALATAN in the treatment of ocular hypertension or glaucoma results from two randomized clinical trials Acta Ophthalmol Scand 2004 Feb82142-8
Latina MA Tumbocon Ja SLT a new treatment option for open-angle glaucoma Curr Opin Ophthalmol 2002 1394-6
Cases who dont achieve target IOP following SLT therapy need additional treatment in form of topical medications Conventionally common topical antiglaucoma medications to treat glaucoma after SLT therapy either suppress aqueous secretion B-blockers or carbonic anhydrase inhibitors or enhances uveoscleral aqueous outflow Prostaglandin analogues Since Selective Laser Trabeculoplasty acts on outflow pathway further additional IOP reduction can be achieved more effectively by a class of drug which acts on different pathway on aqueous secretion by aqueous suppressants like Cosopt In contrast drugs acting on outflow pathway like prostaglandin analogue Xalatan etc will possibly be less additive in further reducing IOP after SLT since SLT also has effect on the same pathway- outflow pathway
Previous studies Fechtner et al J Ocul Pharmacol Ther 2005 Jun213242-9 and Fechtner et al Acta Ophthalmol Scand 2004 Feb82142-8 have shown equal efficacy of Cosopt and Latanoprost in reducing IOP in treatment of glaucoma But to our knowledge no long term prospective study has evaluated aqueous suppressants Cosopt and prostaglandin analogues with respect to their comparative efficacy in treatment of uncontrolled glaucoma status post SLT therapy
OBJECTIVE The primary objective of this study is to compare the IOP lowering efficacy of aqueous suppressants Cosopt and prostaglandin analogues Xalatan when used status post SLT in the management of Open Angle Glaucoma or Ocular Hypertension
INCLUSION CRITERIA 1 Adult subjects of either sex of any race eighteen years of age or older 2 Diagnosis Primary Open Angle Glaucoma Pseudoexfoliation Glaucoma Ocular Hypertension
3 Mild to moderate glaucoma only Pattern standard deviation PSD more than 1DB and less than 6 DB on Humphrey Visual Field
3 Subject may be
A newly diagnosed glaucoma or
A pre-existing glaucoma on not more than two topical antiglaucoma medications 3 On no systemic medications known to increase IOP eg steroids 4 Visual acuity equal or better than 20200 in the study eye 5 IOP less than 35 mm Hg in the study eye 6 No previous intraocular surgery within last 6 months except laser PI greater than 3 months ago
EXCLUSION CRITERIA Pigmentary OAG Proliferative diabetic retinopathy History of chronic or recurrent severe inflammatory eye disease ie scleritis uveitis herpes keratitis known allergy to COSOPT or any of Prostaglandin Analogues Chronic Obstructive Airways Disease COPD sinus bradycardia heart rate 60 beats per minute second or third-degree atrioventricular block overt cardiac failure Pregnant and nursing mothers
STUDY DESIGN Single site unmasked prospective randomized study STUDY PROCEDURE
Visit 1 Visit 2 Visit 3 Visit 4 Visit 5 Visit 6 Screening Phase SLT Treatment Phase Safety check 2 weeks after SLT RANDOMIZATION 4 to 6 weeks after SLT Follow up visit 6 weeks after randomization Last Visit 3 months after randomization Determine eligibility by doing routine eye exam including IOP check by Goldmann applanation tonometer Gonioscopy fundus exam Humphrey Visual Field if HVF not done within last 6 months
Subjects who fulfill the eligibility criteria and give consent for participating in study will be scheduled for SLT All eligible subjects will receive SLT Pre-existing glaucoma cases already on antiglaucoma medications will discontinue all the antiglaucoma medications since the day of SLT treatment and will be off the drops for next 4 to 6 weeks Similarly newly diagnosed glaucoma will not be on any antiglaucoma medications for next 4 to 6 weeks Each subject will have IOP check at 2 weeks after SLT treatment It will be done to rule out any unusual IOP spike following SLT Each subject will have routine eye exam including IOP check at this visit The subjects with uncontrolled IOP despite SLT therapy will be randomized to receive either COSOPT or Prostaglandin analogue XALATAN IOP check and routine eye exam IOP check routine eye exam including fundus exam and Humphrey Visual Field
If IOP is uncontrolled at the visit 5 a stepped drug therapy will be initiated based on following protocol
1 For patients who are in Cosopt group after randomization Sequence of additional medications will be following
First Step Alphagan Brimonidine Second Step Prostaglandin Analogues
2 For patients who are in Xalatan group after randomization Sequence of additional medications will be following
First Step Alphagan Brimonidine Second Step Dorzolamide Trusopt
Note IOP will be measured using a Goldmann Applanation Tonometer at 8 AM and 10 AM at visits Visit I Visit IV Visit V and Visit VI A 30 minute window will be allowed for each measurement recording
IOP measurement at Visit II SLT treatment phase and Visit III safety check can be done at random time
Duration of Study Participation Subjects who are eligible to participate in the study shall be enrolled for approximately 6 months References Fechtner RD McCarroll KA Lines CR Adamsons IA Efficacy of the dorzolamidetimolol fixed combination versus latanoprost in the treatment of ocular hypertension or glaucoma combined analysis of pooled data from two large randomized observer and patient-masked studiesJ Ocul Pharmacol Ther 2005 Jun213242-9 Fechtner RD Airaksinen PJ Getson AJ Lines CR Adamsons IA COSOPT versus XALATAN Study Groups
Efficacy and tolerability of the dorzolamide 2timolol 05 combination COSOPT versus 0005 XALATAN in the treatment of ocular hypertension or glaucoma results from two randomized clinical trials Acta Ophthalmol Scand 2004 Feb82142-8
Latina MA Tumbocon Ja SLT a new treatment option for open-angle glaucoma Curr Opin Ophthalmol 2002 1394-6
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