How Similar Are Changes to the Surface of the Eye When Two Different Glaucoma Eye Drops Are Used?
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | November 25, 2008 | ||||
| Last Updated Date | December 20, 2012 | ||||
| Start Date ICMJE | November 2008 | ||||
| Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Tear break up time (TBUT) [ Time Frame: 2 months ] [ Designated as safety issue: No ] Measurement made in seconds using a timer. Average of 3 measurements taken. |
||||
| Original Primary Outcome Measures ICMJE |
Tear break up time (TBUT) [ Time Frame: monthly ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00798694 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE |
Conjunctival hyperemia, ocular surface disease index questionnaire, subject preference, impression cytology, corneal and conjunctival staining, Schirmer test, visual acuity and intraocular pressure. [ Time Frame: monthly ] [ Designated as safety issue: No ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | How Similar Are Changes to the Surface of the Eye When Two Different Glaucoma Eye Drops Are Used? | ||||
| Official Title ICMJE | Ocular Surface Changes With Topical Prostaglandin Analog Therapy | ||||
| Brief Summary | The purpose of this research study is to determine whether one glaucoma eye drop is less likely to cause changes to the surface of the eye (conjunctiva) than another. The investigators plan to determine this theory by comparing the results when a patient is using two different prostaglandins, Xalatan and Travatan Z. (Both of these drops are presently on the market and are approved by the FDA for the treatment of eye pressure). Because this study will be masked, the clinician who reviews the study results will not know what study drop each patient has been using. |
||||
| Detailed Description | Two groups will be entered into this study: group 1 will be naive to treatment and group 2 will be using Xalatan for at least one month. Both groups will be using one drop at bedtime of Xalatan in the right eye and one drop at bedtime of Travatan Z in the left eye. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
||||
| Condition ICMJE | Glaucoma | ||||
| 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 | Completed | ||||
| Enrollment ICMJE | 58 | ||||
| Completion Date | February 2011 | ||||
| Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 21 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00798694 | ||||
| Other Study ID Numbers ICMJE | 08-875 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | L. Jay Katz MD, Wills Eye | ||||
| Study Sponsor ICMJE | Wills Eye | ||||
| Collaborators ICMJE | Pfizer | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Wills Eye | ||||
| Verification Date | December 2012 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||