Dry Eye Syndrome Clinical Trial
Official title:
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
To determine the effect of Essential Fatty Acids (EFA's) on Meibomian Gland lipids and aqueous tear production in patients with "dry eyes".
The effects of essential fatty acids on Meibomian Gland lipid composition and aqueous tear
production may be greater than previously thought. Dry Eye syndromes afflict millions of
people worldwide, more than 10 million in the United States alone. Typically, symptoms that
are associated with dry eye disease include ocular burning, foreign body sensation,
photophobia and other symptoms that result in overall chronic discomfort in patients.
Unfortunately, the effects of Essential Fatty Acids on aqueous tears or Meibomian lipids (AT)
have not been established to date. The purpose of this study is to better understand the role
essential fatty acids play in the maintenance of meibomian gland lipids and overall
production or retention of aqueous tears.
Patients diagnosed with dry eye syndrome will be selected to participate in the study. Once
qualified to take part in the trial, participants randomized to the active comparator arm
will receive four oral doses of soft-gel capsules to be taken daily (QD). Omega-3 Fatty Acid
daily content:
EPA (eicosapentaenoic acid) Dose: 450mg DHA (docosahexaenoic acid) Dose: 300mg Flaxseed Oil
(organic) Dose: 1000mg
Patients on placebo will receive nutritional supplement capsules containing wheat germ oil
but no EFA's. During the trial, patient will be encouraged not to change their diet, use of
topical ophthalmics and systemic therapies other than the use of study treatment. Patient's
topical therapy will be standardized after identification exam so that all patients will use
TheraTears™ four times daily. Patients will be directed to take the masked capsules in the
following manner: 4 soft-gels in the morning.
Masked medication, TheraTears™ and randomization tables will be provided by sponsor.
Subject will have the following tests performed during the first visit (before initiating
treatment) and follow-up (after three months of treatment) visit,: a complete eye exam,
(vital staining of ocular surface and tear break-up time); completion of questionnaires:
Ocular Surface Index (OSDI) and Patient Symptomology Questionnaire will be presented to the
patient to review and answer at both visits: Before initiating treatment and after three
months on therapy, meibography, fluorophotometry will be performed in order to measure tear
volume, flow and turnover, Schirmer test; and tear evaporation using an evaporimeter;
meibomian gland drop out determined by infrared photography and meibomian gland secretion for
biochemical analysis.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02597803 -
Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-1
|
Phase 2/Phase 3 | |
| Completed |
NCT02522312 -
A Retrospective Analysis of Restasis® Benefits in Dry Eye Contact Lens Patients
|
N/A | |
| 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 |
NCT01212471 -
A Dose Ranging Study to Evaluate Safety and Efficacy of Bromfenac Ophthalmic Solution in Dry Eye Disease
|
Phase 3 | |
| 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 |
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 |
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 | |
| Completed |
NCT00514852 -
Safety and Efficacy of an Artificial Tear for the Treatment of Dry Eye
|
N/A |