Efficacy and Safety Safety of Nutritears® in Adults With Dry Eye Syndrome
NCT05481450 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 131
Last updated 2023-05-26
Summary
This is a prospective, randomized, double-blind, parallel, placebo-controlled, clinical interventional study. The purpose of this study is to evaluate the efficacy and safety of Nutritears®, a dietary supplement of OmniActive Health Technologies, in adult subjects with dry eye syndrome (DES). Subjects shall be instructed to consume one capsule of their assigned investigational study product every morning after the breakfast, at the same time every day, for 56 days (8 weeks).
Conditions
- Dry Eye
- Dry Eye Syndromes
Interventions
- DIETARY_SUPPLEMENT
-
Nutritears®
Strength: Lutein/Zeaxanthin - 20/4 mg; Curcuminoids 200 mg; Vitamin D3 600 IU (Total capsule weight ≈670 mg)
- DIETARY_SUPPLEMENT
-
Placebo
Soybean oil capsule (Total capsule weight ≈670 mg)
Sponsors & Collaborators
-
True Eye Experts - New Tampa
collaborator UNKNOWN -
True Eye Experts - Lutz
collaborator UNKNOWN -
True Eye Experts - South Tampa
collaborator UNKNOWN -
Applied Science & Performance Institute
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-08-15
- Primary Completion
- 2023-05-15
- Completion
- 2023-05-22
Countries
- United States
Study Locations
More Related Trials
-
Investigation of Maintaining Visual Performance Achieved With Cyclosporine Therapy
NCT02121847 ·Status: COMPLETED ·Phase: PHASE4
-
ACCURATE Study for Subjects With Dry Eyes
NCT04237012 ·Status: COMPLETED ·Phase: PHASE4
-
Study of the TearCare System in Dry Eye Disease
NCT03588624 ·Status: COMPLETED ·Phase: NA
-
Therapeutic Effect of Stem Cell Eye Drops on Dry Eye Disease
NCT05784519 ·Status: ACTIVE_NOT_RECRUITING ·Phase: EARLY_PHASE1
-
Efficacy of Cyclosporine for the Prevention and Treatment of Dry Eye Symptoms Following LASIK or Photorefractive Keratectomy
NCT00349440 ·Status: COMPLETED ·Phase: PHASE4
-
Objective Measurements of Prolonged Effects of Restasis on Dry Eye Disease
NCT00567177 ·Status: COMPLETED ·Phase: PHASE4
-
Evaluation of the Safety and Effectiveness of the Oculeve Intranasal Lacrimal Neurostimulator in Patients With Dry Eye
NCT02313454 ·Status: COMPLETED ·Phase: NA
-
Study of Two Formulations of Cyclosporine Ophthalmic Emulsion in Healthy Volunteers and in Patients With Dry Eye
NCT01319773 ·Status: COMPLETED ·Phase: PHASE1
-
Oral Omega-3 Fatty Acids in the Treatment of Dry Eye Syndrome
NCT01107964 ·Status: COMPLETED ·Phase: NA
-
Safety and Efficacy of Two Artificial Tears in Dry Eye Subjects
NCT01010282 ·Status: COMPLETED ·Phase: NA
-
Efficacy and Safety of a New Multi-dose Lubricant Eye Drop Concomitant With Restasis® (Cyclosporine A) for the Treatment of Dry Eye Symptoms
NCT00405457 ·Status: COMPLETED ·Phase: PHASE4
-
Evaluation of Maintaining Visual Performance in Participants Who Engage in Electronic Visual Tasking While Using Restasis®
NCT02554981 ·Status: COMPLETED ·Phase: PHASE4
-
The Effects of Dietary Supplementation With Omega-3 Fatty Acids on Symptoms of Dry Eye
NCT03141931 ·Status: COMPLETED ·Phase: NA
-
Study of OT202 in Treating Moderate to Severe Dry Eye
NCT06435182 ·Status: COMPLETED ·Phase: PHASE2
-
Effects of Two Tear Substitutes in Patients With Dry Eye Syndrome
NCT03211351 ·Status: COMPLETED ·Phase: NA
-
Safety and Efficacy of an Artificial Tear for the Treatment of Dry Eye
NCT00514852 ·Status: COMPLETED ·Phase: NA
-
Safety and Efficacy of Cyclosporine Ophthalmic Emulsion in Patients With Primary Pterygium
NCT01109056 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Brimonidine Tartrate Nanoemulsion Eye Drop Solution in the Treatment of Dry Eye Disease (DED)
NCT03785340 ·Status: COMPLETED ·Phase: PHASE3
-
Safety, Efficacy, and Acceptability Study of an Eye Drop Formulation in Subjects With Dry Eye Disease
NCT01459588 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluation of Dry Eye Symptoms in CAE With Application of Intranasal Neurostimulation
NCT02910713 ·Status: COMPLETED ·Phase: NA
-
Treatment With Allogeneic Adipose-derived Mesenchymal Stem Cells in Patients With Aqueous Deficient Dry Eye Disease
NCT03878628 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
Study of the Safety and Efficacy of OmegaD Softgels in the Treatment of Dry Eye Disease
NCT02980224 ·Status: COMPLETED ·Phase: PHASE3
-
Predicting the Success of Dry Eye Disease Interventions Using Clinical Tests
NCT04125134 ·Status: TERMINATED ·Phase: PHASE4
-
A Prospective, Randomized, Placebo and Active Comparator Controlled Study of CP-690,550 in Subjects With Dry Eye.
NCT00784719 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Dry Eye Assessment and Management: Feasibility Study
NCT01102257 ·Status: COMPLETED ·Phase: PHASE2/PHASE3