Clinical Trial Abstract for TheraLife Eye- Relief for Chronic Dry Eye Syndrome
I am new at this forum, and some members have expressed interest in knowing the scientific and clinical data for TheraLife Eye. The company TheraLife was founded in the year 2000 - to which I am a co-founder. I also have chronic dry eyes and am very passionate about helping others who suffer the same. We recommend other products that work to relief dry eyes, and often use them in combination. The purpose here is not to promote TheraLife Eye but to provide information that may answer some of the questions.
Here is the abstract:
Title:A 4 Week Clinical Evaluation of the Efficacy and Safety of Oral TheraLife Eye Product for the Treatment of
Moderate Dry Eye Disease
Authors: Todd Severin, MD, Ron Seger, OD, Don Robinson, OD, Judy Turkalj, MD4,, Armin Ramel, PhD, Yuanjin Tao, OMD L.Ac
Objective: To compare the efficacy and safety of oral TheraLife Eye plus Enhancer formulae to placebo in patients with mild to moderate dry eye disease.
Design: Randomized at 2:1 ratio of treated versus placebo, multi-center, and double masked, placebo-controlled trial.
Participants: Total patient enrollment: 82 (treated 53), (placebo 29). Age range from 18 to 71 years old
Intervention: Patients ingested twice daily two TheraLife Eye capsules plus two TheraLife Enhancer capsules during week one and two, followed by two TheraLife Eye capsules twice daily during week 3 and 4. Control group received placebo capsules, which contained rice powder on an identical dosage and frequency regimen.
Efficacy Outcome Measures: Objective and subjective parameters were evaluated employing: conjunctiva injection, fluorescence tear breakup time, corneal staining, Zone Quick (phenol red thread to measure tear quantity), Rose Bengal staining, contact lens discomfort and overall ocular discomfort symptoms. Objective and subjective parameters of each eye were evaluated and computed separately.
Safety: Adverse effects were duly recorded.
Results: The combined TheraLife Eye formulae produced significant improvements in tear breakup (p0.0032), and zone quick test (p0.003). Among the subjective measures, significant improvements were noted in burning (p0.03); dryness (p0.001); tiredness (p0.001); contact lens discomfort (p0.0018); redness (p0.016); excessive blinking (p0.001); and overall ocular discomfort (p0.001). Investigator and subject global assessments demonstrated greater improvement in the treatment (p0.001) versus the placebo group. The combined TheraLife Eye plus Enhancer formulae exhibited an excellent safety profile without significant adverse effects.
Conclusion: The oral ophthalmic formulation was safe and effective in the treatment of mild to moderate dry eye symptom as demonstrated by improvements in both objective and subjective measures. TheraLife oral formulations may well provide significant patient benefits to those with dry eye symptoms.
Dr. Lily C. Yang
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