Effects of Anti-Glaucoma Medications on the Ocular Surface (BAK)
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|ClinicalTrials.gov Identifier: NCT01315574|
Recruitment Status : Terminated (Slow Enrollment)
First Posted : March 15, 2011
Results First Posted : February 3, 2017
Last Update Posted : March 16, 2017
The purpose of the study is to compare the efficacy of FDA-approved Travoprost (Travatan Z) and Latanoprost (Xalatan)as anti-glaucoma treatment. Several studies indicate that glaucoma medications may be associated with decreased tear production and tear film break-up time (TBUT), and increased inflammatory cells in the conjunctiva (membrane lining of the eye lids and the covering of the eye) leading to dry eye. Normal tear film (coating of the eye) is continuous and blinking maintains the tear film continuity. If you keep your eyes open long enough without blinking, the tear film will start breaking up. Your eye will feel uncomfortable forcing you to blink. In patients with dry eyes, the tear film is unstable, and breaks up faster. Therefore the tear break up time in patients who have dry eyes is shorter.
In this study, the investigators will be comparing the two previously mentioned FDA-approved eye drops Latanoprost and Travoprost. The difference between the two medications is a preservative called benzalkonium chloride (BAK). Latanoprost contains BAK while Travoprost does not. The investigators will be comparing the efficacy of each medication in lowering IOP as well as trying to track the density of immune cells across the corneal surface by taking photos of your eye. The investigators will also be assessing whether either drop leads to symptoms of dry eye by comparing results from ocular surface exam tests such as TBUT.
|Condition or disease||Intervention/treatment||Phase|
|Glaucoma||Drug: Travoprost Drug: Latanoprost||Phase 4|
The purpose of the study is to compare the early effects of two anti-glaucoma eye drops on eye pressure and inflammation of the eye using a microscope. One of the eye drops contains a commonly used preservative, benzalkonium chloride (BAK), while the other is free of this preservative, instead it utilises a new ionic buffer system called SofZia. Prolonged use of BAK may be damaging to the eye surface and thus being investigated at a microscopic level in this study.
Specific aims are to assess the in vivo effect of topical BAK-containing and BAK-free prostaglandin analogue anti-glaucoma therapy on intraocular pressure (IOP), as well as on density and morphology of corneal immune cells, epithelial cells and sub-basal nerve plexus.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||In Vivo Effects of Antiglaucomatous Prostaglandin Therapy on Immune Cells, Epithelium, and Nerves of the Ocular Surface: A Laser In Vivo Confocal Microscopy Study|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
Active Comparator: Latanoprost (Xalatan)
7 Patients were randomized to receive BAK-containing Xalatan for treatment of their glaucoma.
One drop Xalatan (0.005% ophthalmic solution) in affected eye once daily.
Other Name: Xalatan
Active Comparator: Travoprost (Travatan Z)
7 Patients were randomized to receive BAK-free Travatan Z for treatment of their glaucoma.
One drop Travatan Z (0.004% ophthalmic solution) in affected eye once daily.
Other Name: Travatan Z
- Effectiveness in Lowering Intraocular Pressure [ Time Frame: At the 6 month follow-up time point ]Applanation tonometry will be used to measure patients' intraocular pressure
- Corneal Fluorescein Staining Score [ Time Frame: At the 6 month follow-up time point ]Corneal Fluorescein Staining score was used in this study to quantify changes in dry eye symptoms. Corneal fluorescein staining scores range from 0 to 4 points: 0=non-staining to 4 =regional whole staining of the cornea. Higher scores indicate worse eye condition.
- Tear Film Break-Up Time [ Time Frame: At the 6 month follow-up time point ]Tear Film Break-Up Time (TBUT) is a clinical test used to quantify changes in dry eye symptoms. The Tear Film Break-Up time is the number of seconds between the subjects last blink and the detection of the first dry spot in the tear film.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01315574
|United States, Massachusetts|
|Massachusetts Eye and Ear Infirmary|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Pedram Hamrah, MD||Mass Eye and Ear Infirmary|