Open Angle Glaucoma Clinical Trial
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.
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 U.S. 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.
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 don’t 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 Jun;21(3):242-9 and Fechtner
et al. Acta Ophthalmol Scand. 2004 Feb;82(1):42-8.) 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 (e.g. steroids) 4 Visual acuity equal or
better than 20/200 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 (i.e. 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 dorzolamide/timolol 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 studies.J Ocul Pharmacol Ther. 2005
Jun;21(3):242-9 Fechtner RD, Airaksinen PJ, Getson AJ, Lines CR, Adamsons IA; COSOPT versus
XALATAN Study Groups.
Efficacy and tolerability of the dorzolamide 2%/timolol 0.5% combination (COSOPT) versus
0.005% (XALATAN) in the treatment of ocular hypertension or glaucoma: results from two
randomized clinical trials. Acta Ophthalmol Scand. 2004 Feb;82(1):42-8.
Latina MA, Tumbocon Ja. SLT: a new treatment option for open-angle glaucoma. Curr Opin
Ophthalmol 2002; 13:94-6
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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