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

NCT ID: NCT00565669

Last Updated: 2018-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2008-10-31

Brief Summary

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.

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.

Conditions

Dry Eye Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Blink Tears

Group Type: EXPERIMENTAL

Cyclosporin A Restasis®

Intervention Type: DRUG

Blink tears

Intervention Type: DRUG

blink tears to be used twice a day

Systane

Group Type: EXPERIMENTAL

Cyclosporin A Restasis®

Intervention Type: DRUG

Systane

Intervention Type: DRUG

systane to be used twice a day

Interventions

Cyclosporin A Restasis®

Intervention Type: DRUG

Blink tears

blink tears to be used twice a day

Intervention Type: DRUG

Systane

systane to be used twice a day

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kerry D. Solomon, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina, Storm Eye Institute

Locations

Medical University of South Carolina, Storm Eye Institute

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

SEI-07-003

Identifier Type: -

Identifier Source: org_study_id