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Evaluation of Blink Tears and Systane Concomitant With Restasis for the Treatment of Dry Eye Symptoms

This study has been completed.
Sponsor:
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00565669
First received: November 29, 2007
Last updated: October 1, 2010
Last verified: October 2010
  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

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • 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
Criteria

Inclusion Criteria:

  1. Subject must have dry eye.
  2. Age: 18 years and older.
  3. Males or females
  4. Up to grade 3 conjunctival staining.
  5. Score of no more than 4 on the Subjective Evaluation of Symptoms of Dryness (SESOD) at screening.
  6. Currently using Restasis to treat dry eye syndrome (at least for 3 months prior to enrollment).
  7. Willing and able to comply with scheduled visits and other study procedures.

Exclusion Criteria:

  1. Prior unsuccessful use of topical cyclosporine (defined as patients taking it at least 3 months without improvement.
  2. Known contraindications to any study medication or ingredients.
  3. Planned use of contact lenses (unless discontinued use more than 30 days prior to randomization.
  4. Contact lens use during the active treatment portion of the trial.
  5. Active ocular allergies.
  6. Ocular surgery within the past 3 months.
  7. Any concurrent infectious/non infectious conjunctivitis, keratitis or uveitis.
  8. Active ocular diseases or uncontrolled systemic disease (blepharitis patients that are actively being treated or disease that is uncontrollable.
  9. Pregnant or nursing mothers and females of childbearing potential not practicing a reliable and medically acceptable method of birth control.
  10. Participation in (or current participation) any investigational drug or device trial.
  11. Conjuctival staining grade 4.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00565669

Locations
United States, South Carolina
Medical University of South Carolina, Storm Eye Institute
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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
Conjunctival Diseases
Conjunctivitis
Corneal Diseases
Eye Diseases
Keratitis
Keratoconjunctivitis
Lacrimal Apparatus Diseases
Cyclosporine
Cyclosporins
Anti-Infective Agents
Antifungal Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014