Evaluation of Blink Tears and Systane Concomitant With Restasis for the Treatment of Dry Eye Symptoms
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Purpose
The purpose of this study is to evaluate the efficacy of Blink Tears and Systane used concomitantly with topical cyclosporine for the treatment of dry eye.
| Condition | Intervention |
|---|---|
|
Dry Eye Syndrome |
Drug: Cyclosporin A Restasis® |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Evaluation of Blink Tears and Systane Concomitant With Restasis for the Treatment of Dry Eye Symptoms |
- Dry eye syndrome [ Time Frame: Prospective ] [ Designated as safety issue: No ]Cyclosporin A (Restasis®, Allergan, Irvine, CA) has been shown to significantly reduce the number of activated T-lymphocytes within the conjunctiva6, thereby minimizing the inflammation causing dry eye. Topical cyclosporin A 0.05% ophthalmic emulsion (Restasis®, Allergan, Irvine, CA) increases tear production and improves the quality of naturally produced tears and is the first approved therapeutic agent for the treatment of chronic dry eye and the only treatment modality that addresses the underlying pathology.
| Enrollment: | 20 |
| Study Start Date: | October 2007 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Cyclosporin A Restasis®
Topical cyclosporin A 0.05% ophthalmic emulsion (Restasis®, Allergan, Irvine, CA)
|
Drug: Cyclosporin A Restasis®
systane to be used twice a day for the duration of the study
Other Name: Cyclosporin A Restasis®
|
Detailed Description:
Dry eye is a chronic condition that is believed to afflict more than 3 million patients in the United States.1 Symptoms of dry eye are very bothersome and impact quality of life, reduce work capacity, and may result in poorer psychological health. Also, symptoms of dry eye are associated with a decreased ability to perform activities that require visual attention such as reading and driving a car.2 Patients with dry eye complain most frequently of a scratchy or sandy (foreign body) sensation. Other common symptoms are itching, excessive mucus secretion, inability to produce tears, a burning sensation, photosensitivity, redness, pain, and difficulty in moving the lids. In most patients, the most remarkable feature of the eye examination is the grossly normal appearance of the eye.3 Chronic dry eye disease is associated with an inflammatory mechanism mediated by activated T-cell lymphocytes3 which affects the ocular surface and lacrimal gland.4 The damage caused by dry eye disease may be irreversible, and despite the availability of various tear substitutes, many patients with dry eye syndrome experience corneal injuries with a subsequent reduction in vision.5 Cyclosporin A (Restasis®, Allergan, Irvine, CA) has been shown to significantly reduce the number of activated T-lymphocytes within the conjunctiva6, thereby minimizing the inflammation causing dry eye. Topical cyclosporin A 0.05% ophthalmic emulsion (Restasis®, Allergan, Irvine, CA) increases tear production and improves the quality of naturally produced tears and is the first approved therapeutic agent for the treatment of chronic dry eye and the only treatment modality that addresses the underlying pathology.
In addition to topical therapy with cyclosporine, some patients continue to use artificial tears for occasional relief of residual symptoms. The choice of concomitant tear is important but little research has been published differentiating between the efficacy of these solutions when used concomitantly with topical cyclosporine.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subject must have dry eye.
- Age: 18 years and older.
- Males or females
- Up to grade 3 conjunctival staining.
- Score of no more than 4 on the Subjective Evaluation of Symptoms of Dryness (SESOD) at screening.
- Currently using Restasis to treat dry eye syndrome (at least for 3 months prior to enrollment).
- Willing and able to comply with scheduled visits and other study procedures.
Exclusion Criteria:
- Prior unsuccessful use of topical cyclosporine (defined as patients taking it at least 3 months without improvement.
- Known contraindications to any study medication or ingredients.
- Planned use of contact lenses (unless discontinued use more than 30 days prior to randomization.
- Contact lens use during the active treatment portion of the trial.
- Active ocular allergies.
- Ocular surgery within the past 3 months.
- Any concurrent infectious/non infectious conjunctivitis, keratitis or uveitis.
- Active ocular diseases or uncontrolled systemic disease (blepharitis patients that are actively being treated or disease that is uncontrollable.
- Pregnant or nursing mothers and females of childbearing potential not practicing a reliable and medically acceptable method of birth control.
- Participation in (or current participation) any investigational drug or device trial.
- Conjuctival staining grade 4.
Contacts and Locations| United States, South Carolina | |
| Medical University of South Carolina, Storm Eye Institute | |
| Charleston, South Carolina, United States, 29425 | |
| Principal Investigator: | Kerry D. Solomon, MD | Medical University of South Carolina, Storm Eye Institute |
More Information
No publications provided
| Responsible Party: | Kerry S. Solomon, Medcial University of South Carolina |
| ClinicalTrials.gov Identifier: | NCT00565669 History of Changes |
| Other Study ID Numbers: | SEI-07-003 |
| Study First Received: | November 29, 2007 |
| Last Updated: | October 1, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Medical University of South Carolina:
|
Treatment Dry Eye |
Additional relevant MeSH terms:
|
Dry Eye Syndromes Keratoconjunctivitis Sicca Lacrimal Apparatus Diseases Eye Diseases Keratoconjunctivitis Conjunctivitis Conjunctival Diseases Keratitis Corneal Diseases Cyclosporins Cyclosporine |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antifungal Agents Anti-Infective Agents Therapeutic Uses Dermatologic Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 22, 2013