Systane Ultra Versus Maxidex Versus Saline

Dry Eye Disease Clinical Trial

Official title: Study to Evaluate the Ocular Surface Healing Action of the Artificial Tear Systane ULTRA Using Both Positive (Maxidex) and Negative (Saline Solution) Controls

Status Completed

Clinical Trial Summary

This study was to evaluate the healing action on the eye surface of the artificial tear Systane® ULTRA as compared to two other eyedrops: Maxidex and Saline solution. Dry eye disease leads to inflammation of the eye surface and treating dry eyes with artificial tears may lead to reduction in this inflammation and improvement of symptoms and signs.

Clinical Trial Description

For all patients who present to the office with a history of dry eyes:

1. Consent forms will be obtained from every patient. Informed consent will be discussed with the patient in detail. Every topic will be addressed separately. All risks, benefits, and alternatives will be discussed. Patient will be allowed to ask questions, and all questions will be answered. The assessment will be made after that conversation, whether or not the patient understood the consent as described above. Each subject will be allowed as much time as needed to review and sign the consent forms.

2. All patients will be asked to fill out the Ocular Surface Discomfort Index (OSDI) questionnaire to ensure they meet the inclusion criteria. If patients score meets eligibility requirements a general and ocular history will be taken. (Time: 10 min)

3. A pregnancy test will be given to all female subjects of child bearing age. A standard eye exam will be performed to rule out any other ocular pathology besides refractive error. This allows for confirmation that all study subjects have dry eye disease. Topical fluorescein and lissamine dye will be used to record staining on the cornea and conjunctiva of subjects as well as the tear film break-up time (TFBUT). Both of these dyes are used as standard-of-care in eye exams around the country. TFBUT will first be determined through application of sodium fluorescein onto the eye using DET strip. Following triplicate evaluation of TFBUT in each eye, ocular staining will be determined with liquid fluorescein and lissamine dyes administered in liquid form. (Time 15 min).

4. Patients will be given Alcon questionnaires to fill out, inquiring about past treatments, daily symptoms and distress associated with their dry eye disease. (Time:15 minutes) This also serves as a waiting period for some of the dye to wash out.

5. Using a graduated disposable 5 µl microcapillary tube (Wiretol-Micropipettes, Drummond Scientific Co., Broomall, PA, USA) up to 5 µl of tears / eye will be collected from the inferior temporal tear meniscus of each participant, without corneal anesthesia, taking care to ensure that the lid margin and corneal surface were not touched. A maximum of 5 minutes will be allowed per eye for collection of minimal 5 uL of tear. Tears will be immediately dispensed into pre-labeled Eppendorf tubes and placed on dry ice until transferred to -80oC for storage. (Time: 10 minutes)

6. A technique known as Impression Cytology (IC) will be used to isolate epithelial cells from the conjunctiva. Anesthetic drops will be administered to each eye before the procedure. Blunted forceps are used to gently press a piece of filter paper against the patient's conjunctiva. The paper is gently lifted off, and sent to the Mount Sinai Laboratory for analyses. (Estimated collection time: 15 minutes). A total of 6 pieces per patient (3 pieces per eye) will be collected on each scheduled visit. For HLA-DR analysis, 2 pieces from each eye will be held at room temperature in a vial containing fixative until assay. The remaining 1 piece from each eye will be pooled together in one vial for RT-PCR assays in the following order: (1) immediately merged into a pre-labeled Eppendorf tube with 600 µL of TriZol Reagent; (2) Vortex for 30 seconds; (3) sealed with Saran Wrap; (4) transfer to -80C for storage until assay.

7. Measurement of Intraocular pressure using Tonopen.

8. As a part of the substudy we intend to treat patients with Systane ULTRA®, Maxidex, (both of which are FDA approved ophthalmic solutions), or the saline solution placebo. Subjects will be assigned to one of the three groups as per randomization sequence and the corresponding eye drop will be dispensed.

9. The patient's response to treatment will be assessed after approximately 4 weeks (+/- 5 days) using the same diagnostic tests in order to assess the sensitivity of these diagnostic tests to detect the response to medical treatment of dry eye disease. In addition to baseline and 4 week visits, safety evaluations will be performed at a 2 week (+/- 5 days) visit. All the procedures done during the baseline visit will be repeated except pregnancy test, tear collection and impression cytology. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Disease
• Eye Diseases

• NCT number: NCT01775540
• Study type: Interventional
• Source: Icahn School of Medicine at Mount Sinai
• Status: Completed
• Phase: N/A
• Start date: May 2012
• Completion date: October 2012