Lipids of the Human Tear Film and Their Effect on Tear Stability
Recruitment status was Recruiting
| Tracking Information | |||||||||
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| First Received Date ICMJE | December 1, 2008 | ||||||||
| Last Updated Date | November 23, 2010 | ||||||||
| Start Date ICMJE | July 2008 | ||||||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Inflammation of eyelid (Clinical; Phase transition temp (Laboratory) [ Time Frame: 2 months ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00803452 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Character of meibomian gland secretion [ Time Frame: 2 months ] [ Designated as safety issue: No ] | ||||||||
| 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 | Lipids of the Human Tear Film and Their Effect on Tear Stability | ||||||||
| Official Title ICMJE | Lipids of the Human Tear Film and Their Effect on Tear Stability | ||||||||
| Brief Summary | This prospective, randomized, comparative clinical trial evaluates the effect of either oral doxycycline, oral essential fatty acid, or topical azithromycin to modify the secretions of the meibomian gland in subjects with meibomian gland dysfunction and/or dry eye disease. |
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| Detailed Description | Subjects with meibomian gland dysfunction undergo expression of the meibomian gland secretion prior to beginning treatment with either oral doxycycline, oral essential fatty acids, or topical azithromycin solution. Doxycycline is dosed at 100 mg bid; essential fatty acid is dosed at 1000 mg per day; topical azithromycin is delivered once per day as a 1% solution. Treatment with doxycycline is for two months; treatment with essential fatty acids is for two months; treatment with topical azithromycin is for one month. Following treatment, meibomian glands are again expressed and the lipids measured by spectroscopy (FTIR, MALDI-TOF, NMR)for characterization of structure and function. Analysis for presence of doxcycline or azithromycin is also performed. Changes in lipid parameters are correlated with clinical signs and symptoms of disease. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Blepharitis | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Borchman D, Foulks GN, Yappert MC, Bell J, Wells E, Neravetla S, Greenstone V. Human meibum lipid conformation and thermodynamic changes with meibomian-gland dysfunction. Invest Ophthalmol Vis Sci. 2011 Jun 1;52(6):3805-17. Print 2011 May. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 400 | ||||||||
| Estimated Completion Date | December 2010 | ||||||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00803452 | ||||||||
| Other Study ID Numbers ICMJE | lipidtearfilm, NEI RO-1- EY017094-02 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Gary N. Foulks, MD, University of Louisville | ||||||||
| Study Sponsor ICMJE | University of Louisville | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Louisville | ||||||||
| Verification Date | June 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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