Open-Angle GlaucomaXal-CosNCT00815373
The Effects of Cosopt® Vs Xalacom® on Ocular Hemodynamics and Intraocular Pressure (IOP) in Primary Open-angle Glaucoma (POAG)
A study testing Dorzolamide+Timolol Maleate0.5% and Latanoprost+Timolol Maleate0.5%+Lytears in people with Open-Angle Glaucoma and Ocular Hypertension, run by Meir Medical Center at 1 site in Israel.
Trial summary
Both Cosopt® and Xalatan® plus Timoptic® will significantly lower IOP, however only Cosopt® will demonstrate positive hemodynamic effects. The clinical significance of this will be investigated by examining the ophthalmic and short posterior ciliary arteries to determine the blood supply to the optic nerve head, the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open-Angle Glaucoma, Ocular Hypertension
- What is being tested?
- Dorzolamide+Timolol Maleate0.5% and Latanoprost+Timolol Maleate0.5%+Lytears
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2008to Jun 2012
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or greater.
- Patient signed an informed consent agreement.
- Corrected visual acuity of 6/12 or better:
- Characteristic glaucomatous visual-field loss and optic nerve head damage in one or both eyes.
- Either IOP measurements ≥21 mmHg in the 3 months prior to study entry or IOP ≥ 21 mmHg at the end of the washout period
- Patient on ≥1 IOP reducing agents. -
Who cannot join
- Past history of ocular diseases (other than OAG / Cataract / Refractive error).
- Past history of orbital/ocular surgery or trauma.
- Receiving ≥ 3 IOP reducing agents.
- Receiving agents known to produce significant cardiovascular, respiratory, renal or hepatic side effects.
- Personal history of respiratory disease such as asthma, emphysema or other chronic obstructive pulmonary disease.
- Personal history of congestive heart failure.
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- Personal history of bradycardia or 2nd and 3rd degree AV block.
- Known allergy to sulfa.
- Women who are pregnant or nursing.
- Women who of child bearing age who are planning to become pregnant within one month after study completion.
- Receiving Levitra, Viagra, Cialis or other erectile dysfunction drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Analysis of the Effects of Cosopt® Versus Xalacom® on Ocular Hemodynamics and Intraocular Pressure in Patients With Primary Open-angle Glaucoma
Both Cosopt® and Xalatan® plus Timoptic® will significantly lower IOP, however only Cosopt® will demonstrate positive hemodynamic effects. The clinical significance of this will be investigated by examining the ophthalmic and short posterior ciliary arteries to determine the blood supply to the optic nerve head, the site of damage in glaucoma
Read the detailed description
Background and Rationale
Apoptosis of retinal ganglion cell has been considered as the most plausible pathogenic mechanism of glaucoma. Apoptosis can be caused by neurotrophic factor withdrawal or glutamate release and both of them are triggered by elevated intraocular pressure (IOP) and ischemia simultaneously or separately.
The topical carbonic anhydrase inhibitor, Dorzolamide (Trusopt*), has recently been approved for chronic use in the treatment of glaucoma. The ocular hypotensive effects of this topical carbonic anhydrase inhibitor seem likely to produce the same results as *-adrenergic antagonists. Systemic carbonic anhydrase inhibitors are known to have vasodilatory effects (Maren,1987). Rassam S.M.B., Patel V. and Kohner E.M. (1993) have concluded that acetazolamide causes an increase in retinal blood flow in the human retinal circulation. It has also been demonstrated that Trusopt* increases retinal circulation as measured by scanning laser ophthalmoscopy (SLO) (Harris, Arend, Martin, 1996). Furthermore, Trusopt increases arteriovenous passage (AVP) time and improves contrast sensitivity in normal tension glaucoma patients (Harris, 1999).
Cosopt* (dorzolamide hydrochloride-timolol maleate ophthalmic solution) is combination of a topical carbonic anhydrase inhibitor and a topical beta-adrenergic receptor blocking agent. Each of these two components reduces intraocular pressure. The IOP-reducing effect of Cosopt b.i.d. was greater (1-3 mm Hg) than that of monotherapy with either 2.0 % dorzolamide t.i.d. or 0.5 % timolol b.i.d. The IOP-lowering effect of Cosopt* b.i.d. was approximately 1 mm Hg less than that of concomitant therapy with 2.0% dorzolamide t.i.d. and 0.5 % timolol b.i.d. A previous study showed that the retinal circulation (AVP time) was significantly accelerated after replacing Timoptic* with Cosopt* in glaucoma patients (Harris, 1999).
Latanoprost (Xalatan*) is a prostaglandin F2* analogue which is believed to reduce IOP by increasing the outflow of aqueous humor. The retinal vascular effects of Latanoprost, however, remain unclear. While some studies have shown PGF2* to induce constriction in bovine isolated aqueous veins (Nielsen 1996), other studies have been unable to demonstrate an effect on retrobulbar flow velocities (Drance 1996). It is possible that vasoconstrictive properties of the drug may produce a negative impact on previously ischemic retinal tissue or at best no change.
In a recent study comparing Trusopt® with Xalatan® some very encouraging results emerged, AVP time was significantly reduced with Trusopt®, but not with Xalatan® despite the fact that Xalatan® increases perfusion pressure (due to IOP) more than Trusopt®. This is the strongest evidence so far of a pressure independent effect of Trusopt® on ocular blood flow.
Objectives
- To compare the IOP efficacy of Cosopt® and Xalacom® on IOP.
- To determine the perfusion pressure effect of Cosopt® and Xalacom®.
- To determine the blood flow effect of the two drugs on the ophthalmic, central retinal and short posterior ciliary arteries, using Color Doppler Imaging (CDI).
- Conditions
- Open-Angle Glaucoma, Ocular Hypertension
- Being tested
- Dorzolamide+Timolol Maleate0.5%, Latanoprost+Timolol Maleate0.5%+Lytears
- Keywords
- Ocular Blood flow, Ocular hypertension, POAG, Ocular hemodynamics, Xalacom, Cosopt
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dorzolamide+Timolol Maleate0.5%Drug
Also called Cosopt
Cosopt* b. i. d.
Latanoprost+Timolol Maleate0.5%+LytearsDrug
Also called Xalacom* QHS
Xalacom* QHS
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Cosopt* b. i. d. (dosed morning and bedtime) will be administered topically Receives: Drug: Dorzolamide+Timolol Maleate0.5% |
| 2 | Active comparator | Xalacom* q.d.(dosed bedtime) and placebo vehicle q.d. (dosed morning) topically in the other group Receives: Drug: Latanoprost+Timolol Maleate0.5%+Lytears |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular hemodynamics as measured by Color Doppler imaging
Measured: 3 years
Secondary outcomes (1)
Intraocular pressure as measured by Goldmann applanation tonometry
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionDec 2011 (estimated)
- Study completionJun 2012 (estimated)
Why it stopped: no participants recruded.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open-Angle GlaucomaStudies 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 N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Adi Abulafia, MD, Principal investigator, Meir Medical Center, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00815373
- Sponsor's protocol ID
- 0155-08-MMC
- Acronym
- Xal-Cos
- Status last verified
- Mar 2012
- First submitted
- 9 Dec 2008
- Last updated
- 16 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Analysis of the Effects of Cosopt® Versus Xalacom® on Ocular Hemodynamics and Intraocular Pressure in Patients With Primary Open-angle Glaucoma
- ClinicalTrials.gov ID
- NCT00815373
- Acronym / sponsor ID
- Xal-Cos / 0155-08-MMC
- Conditions
- Open-Angle Glaucoma, Ocular Hypertension
- Keywords
- Ocular Blood flow, Ocular hypertension, POAG, Ocular hemodynamics, Xalacom, Cosopt
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no participants recruded.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 30 Dec 2008 (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.
Both Cosopt® and Xalatan® plus Timoptic® will significantly lower IOP, however only Cosopt® will demonstrate positive hemodynamic effects. The clinical significance of this will be investigated by examining the ophthalmic and short posterior ciliary arteries to determine the blood supply to the optic nerve head, the site of damage in glaucoma
Detailed description
Background and Rationale
Apoptosis of retinal ganglion cell has been considered as the most plausible pathogenic mechanism of glaucoma. Apoptosis can be caused by neurotrophic factor withdrawal or glutamate release and both of them are triggered by elevated intraocular pressure (IOP) and ischemia simultaneously or separately.
The topical carbonic anhydrase inhibitor, Dorzolamide (Trusopt*), has recently been approved for chronic use in the treatment of glaucoma. The ocular hypotensive effects of this topical carbonic anhydrase inhibitor seem likely to produce the same results as *-adrenergic antagonists. Systemic carbonic anhydrase inhibitors are known to have vasodilatory effects (Maren,1987). Rassam S.M.B., Patel V. and Kohner E.M. (1993) have concluded that acetazolamide causes an increase in retinal blood flow in the human retinal circulation. It has also been demonstrated that Trusopt* increases retinal circulation as measured by scanning laser ophthalmoscopy (SLO) (Harris, Arend, Martin, 1996). Furthermore, Trusopt increases arteriovenous passage (AVP) time and improves contrast sensitivity in normal tension glaucoma patients (Harris, 1999).
Cosopt* (dorzolamide hydrochloride-timolol maleate ophthalmic solution) is combination of a topical carbonic anhydrase inhibitor and a topical beta-adrenergic receptor blocking agent. Each of these two components reduces intraocular pressure. The IOP-reducing effect of Cosopt b.i.d. was greater (1-3 mm Hg) than that of monotherapy with either 2.0 % dorzolamide t.i.d. or 0.5 % timolol b.i.d. The IOP-lowering effect of Cosopt* b.i.d. was approximately 1 mm Hg less than that of concomitant therapy with 2.0% dorzolamide t.i.d. and 0.5 % timolol b.i.d. A previous study showed that the retinal circulation (AVP time) was significantly accelerated after replacing Timoptic* with Cosopt* in glaucoma patients (Harris, 1999).
Latanoprost (Xalatan*) is a prostaglandin F2* analogue which is believed to reduce IOP by increasing the outflow of aqueous humor. The retinal vascular effects of Latanoprost, however, remain unclear. While some studies have shown PGF2* to induce constriction in bovine isolated aqueous veins (Nielsen 1996), other studies have been unable to demonstrate an effect on retrobulbar flow velocities (Drance 1996). It is possible that vasoconstrictive properties of the drug may produce a negative impact on previously ischemic retinal tissue or at best no change.
In a recent study comparing Trusopt® with Xalatan® some very encouraging results emerged, AVP time was significantly reduced with Trusopt®, but not with Xalatan® despite the fact that Xalatan® increases perfusion pressure (due to IOP) more than Trusopt®. This is the strongest evidence so far of a pressure independent effect of Trusopt® on ocular blood flow.
Objectives
- To compare the IOP efficacy of Cosopt® and Xalacom® on IOP.
- To determine the perfusion pressure effect of Cosopt® and Xalacom®.
- To determine the blood flow effect of the two drugs on the ophthalmic, central retinal and short posterior ciliary arteries, using Color Doppler Imaging (CDI).
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Dorzolamide+Timolol Maleate0.5%Cosopt* b. i. d. (dosed morning and bedtime) will be administered topically |
| 2 | Active comparator | Drug: Latanoprost+Timolol Maleate0.5%+LytearsXalacom* q.d.(dosed bedtime) and placebo vehicle q.d. (dosed morning) topically in the other group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or greater.
- Patient signed an informed consent agreement.
- Corrected visual acuity of 6/12 or better:
- Characteristic glaucomatous visual-field loss and optic nerve head damage in one or both eyes.
- Either IOP measurements ≥21 mmHg in the 3 months prior to study entry or IOP ≥ 21 mmHg at the end of the washout period
Key exclusion criteria (11 listed)
- Past history of ocular diseases (other than OAG / Cataract / Refractive error).
- Past history of orbital/ocular surgery or trauma.
- Receiving ≥ 3 IOP reducing agents.
- Receiving agents known to produce significant cardiovascular, respiratory, renal or hepatic side effects.
- Personal history of respiratory disease such as asthma, emphysema or other chronic obstructive pulmonary disease.
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 |
|---|---|---|
| Dorzolamide+Timolol Maleate0.5%Also: CosoptCosopt* b. i. d. | Drug | 1 |
| Latanoprost+Timolol Maleate0.5%+LytearsAlso: Xalacom* QHSXalacom* QHS | Drug | 2 |
Primary outcome
Ocular hemodynamics as measured by Color Doppler imaging
Time frame: 3 years
1 secondary outcome
Intraocular pressure as measured by Goldmann applanation tonometry
Time frame: 3 Years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2012.
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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.
Adi Abulafia, MD principal investigator
Meir Medical Center, Tel Aviv University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dorzolamide+Timolol Maleate0.5% and Latanoprost+Timolol Maleate0.5%+Lytears in people with Open-Angle Glaucoma and Ocular Hypertension, run by Meir Medical Center at 1 site in Israel.
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 6 inclusion and 11 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: withdrawn, as of the sponsor's last update on 16 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Ocular hemodynamics as measured by Color Doppler imaging (time frame: 3 years). 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 16 Mar 2012.