Open-Angle GlaucomaPhase 4NCT00308945
Influence of Prostaglandins on Ocular Blood Flow in Glaucoma Patients
A Phase 4 study testing travoprost 0.004% (drug) and latanoprost 0.005% (drug) in people with Open-Angle Glaucoma, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Vasoactivity of topical drugs may be of prognostic relevance in glaucoma. There is very little information for a major class, the prostaglandin analogues with regard to this aspect. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Open-Angle Glaucoma
- What is being tested?
- travoprost 0.004% (drug) and latanoprost 0.005% (drug)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2003to Feb 2005
- Phase
- Phase 4
- 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 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients fulfilling two out of three of the following criteria in one or both eyes: a) typical glaucomatous disc, b) visual field damage (a cluster of three points (except rim points) in at least one hemifield reduced by 5 dB or greater and including at least one point reduced by 10 dB or greater; a cluster of two points reduced by 10 dB or greater; or three adjacent points on the nasal horizontal meridian that differed by 5 dB or greater from their mirror points on the opposite side of the meridian), c) intraocular pressure above 21 mm Hg at least at one occasion after washout. No closed iridocorneal angles, evidence of secondary glaucoma, pseudoexfoliation, pigmentary dispersion, or any form of retinal or neuroophthalmologic disease that could result in visual field defects. No history of drug or alcohol abuse.
Who cannot join
- Best corrected visual acuity worse than 2/10 in either eye < 0.2 Snellen. Inadequate transparency of ocular media as defined by physical examination. Severe central field loss defined as a sensitivity < 10dB in at least 2 of the 4 visual field test points closest to the point of fixation. Any abnormality which in the physician's view would prevent reliable applanation tonometry or LDF of both eyes, including an ametropia >3 dpt. History of chronic or recurrent severe inflammatory eye disease such as scleritis or uveitis. History of ocular trauma or intraocular surgery within the past 6 months. History of infection or inflammation within the past 3 months. History of clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy or retinal detachment. A known hypersensitivity to the compounds tested. Need for any concomitant medications that may interfere with the evaluation of ocular blood flow. Variability > 30 % during Laser Doppler Flowmetry (sample of 6 measurements) in both eyes. Pregnancy, breastfeeding, or women in childbearing age without adequate contraception.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Travoprost 0.004% and Latanoprost 0.005% on Retinal Vascular Diameter and Choroidal Blood Flow in Glaucoma Patients
Vasoactivity of topical drugs may be of prognostic relevance in glaucoma. There is very little information for a major class, the prostaglandin analogues with regard to this aspect. The purpose of this study is to compare the effect of travoprost 0.004% and latanoprost 0.005% on choroidal blood flow and retinal vascular diameter in glaucoma patients. After washout of current topical medication, intraocular pressure (IOP) in both eyes (Goldmann applanation tonometry), choroidal blood flow (laser Doppler flowmetry) and retinal vessel diameter (Retinal Vessel Analyzer) in one randomly selected eye will be measured at baseline, after two weeks and after 4 weeks of treatment with travoprost or latanoprost QD, in a randomized, double masked 2-way cross-over study in 20 open angle glaucoma patients.
Read the detailed description
Background Glaucoma is a leading cause of blindness worldwide. Chronic primary open-angle glaucoma is the most common form among Caucasian patients. The key feature of glaucoma is damage to the optic nerve head, which is not necessarily related to an increase in intraocular pressure (IOP). The actual therapeutic armamentarium for glaucoma includes miotics, beta-blockers, alpha-adrenergic agonists, oral and topical carbonic anhydrase inhibitors, and prostaglandin analogues, the latter being the latest addition to the armamentarium and the most potent topical IOP lowering drugs. Besides IOP, ocular blood flow alterations have been incriminated in glaucoma. Hence, it is of relevance to assess the effect of anti-glaucomatous drugs on ocular blood flow.
Rationale of the study Vasoactivity of topical drugs may be of prognostic relevance in glaucoma. There is very little information for a major class, the prostaglandin analogues with regard to this aspect. The vascular activity of two prostaglandin analogues, travoprost 0.004% and latanoprost 0.005%, which are already on the Swiss market, will be tested.
Study objectives Primary Objective: To assess the effect of two prostaglandin analogues, travoprost 0.004% and latanoprost 0.005% on choroidal blood flow in primary open-angle glaucoma patients.
Secondary Objective: To assess the effect of travoprost 0.004% and latanoprost 0.005% on retinal vascular diameter in primary open-angle glaucoma patients.
Investigational plan Primary open-angle-glaucoma patients will be assessed regarding inclusion/exclusion criteria. After a washout of current topical medication (beta-blockers and prostaglandin analogues: 4 weeks; topical carbonic anhydrase inhibitors and alpha-agonists: 2 weeks; Pilocarpine: 1 week), half of the patients (17 patients) will be treated with travoprost 0.004% for 1 month while the other 17 patients will be treated with latanoprost 0.005% for the same duration. Efficacy and safety variables will be assessed at baseline, after 2 weeks, and after 1 month of treatment. After this first period, the patients will be washed out for 4 weeks and baseline efficacy and safety parameters will be obtained. Afterwards, the patients will be treated with the other compound. Again, efficacy and safety variables will be assessed after 2 weeks and after 1 month of treatment.
Design Single center, randomized, double masked 2-way cross-over design. Randomization The patients will be divided in two groups, and each group will alternatively be started with either travoprost 0.004% or latanoprost 0.005%. Recruitment and management will be carried out by a study nurse masked to baseline blood flow measurement results. Masking and randomization procedures will be entrusted to Alcon PHARMACEUTICAL AG. The drug products for this study will be prepared by the following procedure: Each product will be labeled during independent labeling operations. For this study four different products will have to be labeled: travatan medicin A, travatan medicin B, xalatan medicin A and xalatan medicin B. Each labeling operation will start and end with a line clearance procedure and each labeling order will be 100% inspected by a person that is independent from the person who will do the labeling. On each label the patient number will indicated. The labeling order will be initiated by using the randomization list that indicates which product has to be labeled for which patient. The randomization sequence will be pulled from a uniform distribution with an arbitrary seed (Randomization Performed with SAS 8.2 on NT using RANUNI [seed]). During each independent labeling operation also the disclosure labels will be provided with the same patient number than indicated on the open label. After release of each independent labeling procedure, the assembly of the packaging of two carton boxes in an assembly carton box will start for each patient. The assembly box will also be also labeled with patient number/investigator number and protocol number. Release of the labeled samples will always be done by an independent QA department.
- Conditions
- Open-Angle Glaucoma
- Being tested
- travoprost 0.004% (drug), latanoprost 0.005% (drug)
- Keywords
- Glaucoma, Blood flow, Choroid, Retina, Prostaglandin analogues
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
travoprost 0.004% (drug)Drug
local drop application
latanoprost 0.005% (drug)Drug
local drop application
| Study group | Role | What they receive |
|---|---|---|
| 2 | Experimental | cross-over comparison of two substances Receives: Drug: latanoprost 0.005% (drug) |
| 1 | Experimental | Not described Receives: Drug: travoprost 0.004% (drug) |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect on choroidal blood flow
Measured: baseline - 2 weeks - 4 weeks
Secondary outcomes (1)
effect on retinal vascular diameter
Measured: baseline - 2 weeks - 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2006 (estimated)
- Study startNov 2003
- Primary completionFeb 2005
- Study completionFeb 2005
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.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Investigators
- Selim Orgul, MD, Principal investigator, University Eye Clinic Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00308945
- Sponsor's protocol ID
- 003-ZAC-2004-001
- Status last verified
- Jan 2008
- First submitted
- 29 Mar 2006
- Last updated
- 17 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Travoprost 0.004% and Latanoprost 0.005% on Retinal Vascular Diameter and Choroidal Blood Flow in Glaucoma Patients
- ClinicalTrials.gov ID
- NCT00308945
- Acronym / sponsor ID
- 003-ZAC-2004-001
- Conditions
- Open-Angle Glaucoma
- Keywords
- Glaucoma, Blood flow, Choroid, Retina, Prostaglandin analogues
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Nov 2003
- Primary completion
- Feb 2005 (actual)
- Study completion
- Feb 2005 (actual)
- First posted
- 30 Mar 2006 (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.
Vasoactivity of topical drugs may be of prognostic relevance in glaucoma. There is very little information for a major class, the prostaglandin analogues with regard to this aspect. The purpose of this study is to compare the effect of travoprost 0.004% and latanoprost 0.005% on choroidal blood flow and retinal vascular diameter in glaucoma patients. After washout of current topical medication, intraocular pressure (IOP) in both eyes (Goldmann applanation tonometry), choroidal blood flow (laser Doppler flowmetry) and retinal vessel diameter (Retinal Vessel Analyzer) in one randomly selected eye will be measured at baseline, after two weeks and after 4 weeks of treatment with travoprost or latanoprost QD, in a randomized, double masked 2-way cross-over study in 20 open angle glaucoma patients.
Detailed description
Background Glaucoma is a leading cause of blindness worldwide. Chronic primary open-angle glaucoma is the most common form among Caucasian patients. The key feature of glaucoma is damage to the optic nerve head, which is not necessarily related to an increase in intraocular pressure (IOP). The actual therapeutic armamentarium for glaucoma includes miotics, beta-blockers, alpha-adrenergic agonists, oral and topical carbonic anhydrase inhibitors, and prostaglandin analogues, the latter being the latest addition to the armamentarium and the most potent topical IOP lowering drugs. Besides IOP, ocular blood flow alterations have been incriminated in glaucoma. Hence, it is of relevance to assess the effect of anti-glaucomatous drugs on ocular blood flow.
Rationale of the study Vasoactivity of topical drugs may be of prognostic relevance in glaucoma. There is very little information for a major class, the prostaglandin analogues with regard to this aspect. The vascular activity of two prostaglandin analogues, travoprost 0.004% and latanoprost 0.005%, which are already on the Swiss market, will be tested.
Study objectives Primary Objective: To assess the effect of two prostaglandin analogues, travoprost 0.004% and latanoprost 0.005% on choroidal blood flow in primary open-angle glaucoma patients.
Secondary Objective: To assess the effect of travoprost 0.004% and latanoprost 0.005% on retinal vascular diameter in primary open-angle glaucoma patients.
Investigational plan Primary open-angle-glaucoma patients will be assessed regarding inclusion/exclusion criteria. After a washout of current topical medication (beta-blockers and prostaglandin analogues: 4 weeks; topical carbonic anhydrase inhibitors and alpha-agonists: 2 weeks; Pilocarpine: 1 week), half of the patients (17 patients) will be treated with travoprost 0.004% for 1 month while the other 17 patients will be treated with latanoprost 0.005% for the same duration. Efficacy and safety variables will be assessed at baseline, after 2 weeks, and after 1 month of treatment. After this first period, the patients will be washed out for 4 weeks and baseline efficacy and safety parameters will be obtained. Afterwards, the patients will be treated with the other compound. Again, efficacy and safety variables will be assessed after 2 weeks and after 1 month of treatment.
Design Single center, randomized, double masked 2-way cross-over design. Randomization The patients will be divided in two groups, and each group will alternatively be started with either travoprost 0.004% or latanoprost 0.005%. Recruitment and management will be carried out by a study nurse masked to baseline blood flow measurement results. Masking and randomization procedures will be entrusted to Alcon PHARMACEUTICAL AG. The drug products for this study will be prepared by the following procedure: Each product will be labeled during independent labeling operations. For this study four different products will have to be labeled: travatan medicin A, travatan medicin B, xalatan medicin A and xalatan medicin B. Each labeling operation will start and end with a line clearance procedure and each labeling order will be 100% inspected by a person that is independent from the person who will do the labeling. On each label the patient number will indicated. The labeling order will be initiated by using the randomization list that indicates which product has to be labeled for which patient. The randomization sequence will be pulled from a uniform distribution with an arbitrary seed (Randomization Performed with SAS 8.2 on NT using RANUNI [seed]). During each independent labeling operation also the disclosure labels will be provided with the same patient number than indicated on the open label. After release of each independent labeling procedure, the assembly of the packaging of two carton boxes in an assembly carton box will start for each patient. The assembly box will also be also labeled with patient number/investigator number and protocol number. Release of the labeled samples will always be done by an independent QA department.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Experimental | Drug: latanoprost 0.005% (drug)cross-over comparison of two substances |
| 1 | Experimental | Drug: travoprost 0.004% (drug) |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients fulfilling two out of three of the following criteria in one or both eyes: a) typical glaucomatous disc, b) visual field damage (a cluster of three points (except rim points) in at least one hemifield reduced by 5 dB or greater and including at least one point reduced by 10 dB or greater; a cluster of two points reduced by 10 dB or greater; or three adjacent points on the nasal horizontal meridian that differed by 5 dB or greater from their mirror points on the opposite side of the meridian), c) intraocular pressure above 21 mm Hg at least at one occasion after washout. No closed iridocorneal angles, evidence of secondary glaucoma, pseudoexfoliation, pigmentary dispersion, or any form of retinal or neuroophthalmologic disease that could result in visual field defects. No history of drug or alcohol abuse.
Key exclusion criteria (1 listed)
- Best corrected visual acuity worse than 2/10 in either eye < 0.2 Snellen. Inadequate transparency of ocular media as defined by physical examination. Severe central field loss defined as a sensitivity < 10dB in at least 2 of the 4 visual field test points closest to the point of fixation. Any abnormality which in the physician's view would prevent reliable applanation tonometry or LDF of both eyes, including an ametropia >3 dpt. History of chronic or recurrent severe inflammatory eye disease such as scleritis or uveitis. History of ocular trauma or intraocular surgery within the past 6 months. History of infection or inflammation within the past 3 months. History of clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy or retinal detachment. A known hypersensitivity to the compounds tested. Need for any concomitant medications that may interfere with the evaluation of ocular blood flow. Variability > 30 % during Laser Doppler Flowmetry (sample of 6 measurements) in both eyes. Pregnancy, breastfeeding, or women in childbearing age without adequate contraception.
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 |
|---|---|---|
| travoprost 0.004% (drug)local drop application | Drug | 1 |
| latanoprost 0.005% (drug)local drop application | Drug | 2 |
Primary outcome
effect on choroidal blood flow
Time frame: baseline - 2 weeks - 4 weeks
1 secondary outcome
effect on retinal vascular diameter
Time frame: baseline - 2 weeks - 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2008.
- Related InfoLink provided by the sponsor.
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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.
Selim Orgul, MD principal investigator
University Eye Clinic Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing travoprost 0.004% (drug) and latanoprost 0.005% (drug) in people with Open-Angle Glaucoma, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 17 Jan 2008. 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 Switzerland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
effect on choroidal blood flow (time frame: baseline - 2 weeks - 4 weeks). 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 17 Jan 2008.