Primary Vascular DysregulationNCT01201551
Effect of Alphagan and Xalatan Eye Drops on Corneal Temperature
A study testing Brimonidine and Latanoprost in people with Primary Vascular Dysregulation, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
It is already known that the local treatment with Alphagan eye drops (a drug commonly used by glaucoma patients) reduces ocular blood flow. In-vitro studies suggest that the vasoconstrictive effect of Alphagan is more pronounced when this drug is combined with a prostaglandin analogue (eg. Xalatan eye drops). Read more about this study
- Who is it for?
- Ages 18 to 48 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Vascular Dysregulation
- What is being tested?
- Brimonidine and Latanoprost
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2011to Nov 2013
- 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 to 48 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy
- age 18-48 years
- normal findings on ophthalmological examination
Who cannot join
- history of ocular or systemic disease
- chronic or current systemic or topical medication
- drug or alcohol abuse
- art. hypertension
Trial locations and contacts
1 site in 1 country.
About this study
It is already known that the local treatment with Alphagan eye drops (a drug commonly used by glaucoma patients) reduces ocular blood flow. In-vitro studies suggest that the vasoconstrictive effect of Alphagan is more pronounced when this drug is combined with a prostaglandin analogue (eg. Xalatan eye drops). The investigators also question whether this effect is more pronounced in subjects suffering from a primary vascular dysregulation (PVD). To test for the effect of these drugs on PVD and non-PVD subjects the investigators will take measurements of corneal temperature as surrogate for ocular blood flow.
Read the detailed description
The investigators would like to investigate the effect of Alphagan eye drops, Xalatan eye drops and their combination (both Alphagan and Xalatan) on corneal temperature in healthy subjects with and without a primary vascular dysregulation (PVD).
The investigators would like to answer the following questions:
- Do the individual drugs influence the circulation to the eye as quantified indirectly via corneal temperature?
- Does the combination of Alphagan and Xalatan give an additive or even potentiated effect?
- Is the sequence of application of drugs of relevance (Alphagan applied first, Xalatan second, or vice versa)?
- Do PVD and non-PVD subjects respond differently to these drugs?
20 healthy non-PVD subjects and 20 healthy PVD subjects in the age range from 20-40 years will be recruited. Recruited subjects will have all measurements: corneal temperature, intraocular pressure (IOP), ear temperature, blood-pressure. Both prior to and after instillation of eye drops (Xalatan, Alphagan and placebo).
- Conditions
- Primary Vascular Dysregulation
- Being tested
- Brimonidine, Latanoprost, Placebo
- Keywords
- Alphagan, Xalatan, corneal temperature, primary vascular dysregulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrimonidineDrug
Also called Alphagan
Week1, day2: 1 eyedrop/right eye Week2, day1: 1 eyedrop/left eye Week2, day2: 1 eyedrop/left eye
LatanoprostDrug
Also called Xalatan
Week1, day1: 1 eyedrop/right eye Week1, day2: 1 eyedrop/right eye Week2, day2: 1 eyedrop/left eye
PlaceboDrug
Also called Fermavisc
Week1, day1: 1 eyedrop/left eye Week1, day2: 2 eyedrops/left eye Week2, day1: 1 eyedrop/right eye Week2, day2: 2 eyedrops/right eye
| Study group | Role | What they receive |
|---|---|---|
| healthy subjects without PVD | Active comparator | healthy subjects without primary vascular dysregulation Intervention: Brimonidine, Latanoprost and Placebo Receives: Drug: Brimonidine; Drug: Latanoprost; Drug: Placebo |
| healthy subjects with PVD | Active comparator | healthy subjects with primary vascular dysregulation Intervention: Brimonidine, Latanoprost and Placebo Receives: Drug: Brimonidine; Drug: Latanoprost; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal temperature
Measured: Week 1: day 1 and 2 before eyedrops and after. Week 2: day 1 and 2 before eyedrops and after.
Secondary outcomes (3)
Intraocular pressure
Measured: Week 1: day 1 and 2 before eyedrops and after. Week 2: day 1 and 2 before eyedrops and after.
Ear temperature
Measured: Week 1: day 1 and 2 before eyedrops and after. Week 2: day 1 and 2 before eyedrops and after.
Blood pressure
Measured: Week 1: day 1 and 2 before eyedrops and after. Week 2: day 1 and 2 before eyedrops and after.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2010 (estimated)
- Study startJun 2011
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Vascular DysregulationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Josef Flammer, MD, Study director, University of Basel, Dept. of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01201551
- Sponsor's protocol ID
- 088-Mom-2010
- Status last verified
- Dec 2013
- First submitted
- 13 Sep 2010
- Last updated
- 11 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Alphagan and Xalatan Eye Drops on Corneal Temperature
- ClinicalTrials.gov ID
- NCT01201551
- Acronym / sponsor ID
- 088-Mom-2010
- Conditions
- Primary Vascular Dysregulation
- Keywords
- Alphagan, Xalatan, corneal temperature, primary vascular dysregulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 14 Sep 2010 (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.
It is already known that the local treatment with Alphagan eye drops (a drug commonly used by glaucoma patients) reduces ocular blood flow. In-vitro studies suggest that the vasoconstrictive effect of Alphagan is more pronounced when this drug is combined with a prostaglandin analogue (eg. Xalatan eye drops). The investigators also question whether this effect is more pronounced in subjects suffering from a primary vascular dysregulation (PVD). To test for the effect of these drugs on PVD and non-PVD subjects the investigators will take measurements of corneal temperature as surrogate for ocular blood flow.
Detailed description
The investigators would like to investigate the effect of Alphagan eye drops, Xalatan eye drops and their combination (both Alphagan and Xalatan) on corneal temperature in healthy subjects with and without a primary vascular dysregulation (PVD).
The investigators would like to answer the following questions:
- Do the individual drugs influence the circulation to the eye as quantified indirectly via corneal temperature?
- Does the combination of Alphagan and Xalatan give an additive or even potentiated effect?
- Is the sequence of application of drugs of relevance (Alphagan applied first, Xalatan second, or vice versa)?
- Do PVD and non-PVD subjects respond differently to these drugs?
20 healthy non-PVD subjects and 20 healthy PVD subjects in the age range from 20-40 years will be recruited. Recruited subjects will have all measurements: corneal temperature, intraocular pressure (IOP), ear temperature, blood-pressure. Both prior to and after instillation of eye drops (Xalatan, Alphagan and placebo).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy subjects without PVD | Active comparator | Drug: Brimonidine, Drug: Latanoprost, Drug: Placebohealthy subjects without primary vascular dysregulation Intervention: Brimonidine, Latanoprost and Placebo |
| healthy subjects with PVD | Active comparator | Drug: Brimonidine, Drug: Latanoprost, Drug: Placebohealthy subjects with primary vascular dysregulation Intervention: Brimonidine, Latanoprost and Placebo |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy
- age 18-48 years
- normal findings on ophthalmological examination
Key exclusion criteria (4 listed)
- history of ocular or systemic disease
- chronic or current systemic or topical medication
- drug or alcohol abuse
- art. hypertension
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 |
|---|---|---|
| BrimonidineAlso: AlphaganWeek1, day2: 1 eyedrop/right eye Week2, day1: 1 eyedrop/left eye Week2, day2: 1 eyedrop/left eye | Drug | healthy subjects with PVD, healthy subjects without PVD |
| LatanoprostAlso: XalatanWeek1, day1: 1 eyedrop/right eye Week1, day2: 1 eyedrop/right eye Week2, day2: 1 eyedrop/left eye | Drug | healthy subjects with PVD, healthy subjects without PVD |
| PlaceboAlso: FermaviscWeek1, day1: 1 eyedrop/left eye Week1, day2: 2 eyedrops/left eye Week2, day1: 1 eyedrop/right eye Week2, day2: 2 eyedrops/right eye | Drug | healthy subjects with PVD, healthy subjects without PVD |
Primary outcome
Corneal temperature
Time frame: Week 1: day 1 and 2 before eyedrops and after. Week 2: day 1 and 2 before eyedrops and after.
3 secondary outcomes
Intraocular pressure
Time frame: Week 1: day 1 and 2 before eyedrops and after. Week 2: day 1 and 2 before eyedrops and after.
Ear temperature
Time frame: Week 1: day 1 and 2 before eyedrops and after. Week 2: day 1 and 2 before eyedrops and after.
Blood pressure
Time frame: Week 1: day 1 and 2 before eyedrops and after. Week 2: day 1 and 2 before eyedrops and after.
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 11 Dec 2013.
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RecruitingObservational study
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Acute Ischemic Stroke, Transient Ischemic Attack
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.
Josef Flammer, MD study director
University of Basel, Dept. of Ophthalmology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brimonidine and Latanoprost in people with Primary Vascular Dysregulation, 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 3 inclusion and 4 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 11 Dec 2013. 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.
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?
Corneal temperature (time frame: Week 1: day 1 and 2 before eyedrops and after. Week 2: day 1 and 2 before eyedrops and after.). 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 11 Dec 2013.