Effect of Alphagan and Xalatan Eye Drops on Corneal Temperature
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | September 13, 2010 | ||||||||
| Last Updated Date | May 31, 2013 | ||||||||
| Start Date ICMJE | June 2011 | ||||||||
| Estimated Primary Completion Date | October 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Corneal temperature [ Time Frame: Week 1: day 1 and 2 before eyedrops and after. Week 2: day 1 and 2 before eyedrops and after. ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01201551 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Effect of Alphagan and Xalatan Eye Drops on Corneal Temperature | ||||||||
| Official Title ICMJE | Effect of Alphagan and Xalatan Eye Drops on Corneal Temperature | ||||||||
| Brief 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). 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:
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 Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
||||||||
| Condition ICMJE | Primary Vascular Dysregulation | ||||||||
| Intervention ICMJE |
|
||||||||
| Study Arm (s) |
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 40 | ||||||||
| Estimated Completion Date | March 2014 | ||||||||
| Estimated Primary Completion Date | October 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years to 48 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | Switzerland | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01201551 | ||||||||
| Other Study ID Numbers ICMJE | 088-Mom-2010 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | University Hospital, Basel, Switzerland | ||||||||
| Study Sponsor ICMJE | University Hospital, Basel, Switzerland | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | University Hospital, Basel, Switzerland | ||||||||
| Verification Date | May 2013 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||