Dry Eye Syndrome Clinical Trial
Official title:
Evaluation of Blink Tears and Systane Concomitant With Restasis for the Treatment of Dry Eye Symptoms
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02522312 -
A Retrospective Analysis of Restasis® Benefits in Dry Eye Contact Lens Patients
|
N/A | |
Completed |
NCT02597803 -
Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-1
|
Phase 2/Phase 3 | |
Completed |
NCT01863368 -
Clinical Evaluation of Systane® ULTRA Compared to OPTIVE® in Ocular Surface Staining
|
N/A | |
Completed |
NCT01753752 -
Evaluation of the Corneal Residence Time of Chitosan-N-acetylcysteine Eye Drops in Patients With Dry Eye Syndrome After Single and Multiple Instillation
|
Phase 2 | |
Completed |
NCT01753687 -
Correlation of Different Signs for Assessment of Dry Eye Syndrome
|
N/A | |
Completed |
NCT01198782 -
Evaluating Safety and Efficacy of FID 112903 Post Discontinuation of Long-term Use of RESTASIS® (Cyclosporine Ophthalmic Emulsion) 0.05%
|
Phase 4 | |
Completed |
NCT01212471 -
A Dose Ranging Study to Evaluate Safety and Efficacy of Bromfenac Ophthalmic Solution in Dry Eye Disease
|
Phase 3 | |
Completed |
NCT01162954 -
Phase I Study to Evaluate the Tolerability of Eye Drop DA-6034 in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT00544713 -
Evaluate the Safety and Efficacy of a New Artificial Tear for Use After LASIK Surgery
|
N/A | |
Completed |
NCT00535054 -
Study to Assess the Safety and Patients' Satisfaction of Tears Again* in the Treatment of Dry Eye Symptoms
|
N/A | |
Completed |
NCT00344721 -
A Placebo Controlled Double Masked Clinical Assessment Study of Essential Fatty Acid Supplement and Its Effect on Patients With Apparent Aqueous Deficient Dry Eye Syndrome
|
N/A | |
Completed |
NCT03830359 -
Efficacy, Safety of T2769 in Dry Eye Disease
|
N/A | |
Completed |
NCT04139122 -
Safety, PK and Efficacy Study of SJP-0132 in Subjects With Dry Eye Disease
|
Phase 1/Phase 2 | |
Completed |
NCT02758327 -
Evaluation of Tear Osmolarity Over Time With Sustained Use of Thera Tears Lubricating Drops
|
Phase 4 | |
Completed |
NCT02066051 -
IPL and Meibomian Gland Expression to Treat Ocular Rosacea Ocular GVHD
|
N/A | |
Completed |
NCT01970917 -
Effect of Olixia Pure® Eye Drops on Tear Film Thickness in Healthy Subjects
|
Phase 4 | |
Completed |
NCT02092207 -
Phase 2 Study to Evaluation the Safety and Efficacy of Orally Administered KL7016 in Patients With Dry Eye Syndrome
|
Phase 2 | |
Completed |
NCT01541891 -
Efficacy and Safety of PRO-148 Ophthalmic Solution Versus SYSTANE® in the Treatment of Patients With Dry Eye Syndrome
|
Phase 2 | |
Completed |
NCT01252121 -
Residence Time Evaluation of Systane Ultra Lubricant Eye Drops vs. Hialid and Saline
|
N/A | |
Completed |
NCT00765804 -
Safety and Efficacy Study of Iontophoresis and Dexamethasone Phosphate to Treat Dry Eye
|
Phase 2 |