Clinical Trial Abstract for TheraLife Eye- Relief for Chronic Dry Eye Syndrome

[Pegasus]

Hi:

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 (p0.0032), and zone quick test (p0.003). Among the subjective measures, significant improvements were noted in burning (p0.03); dryness (p0.001); tiredness (p0.001); contact lens discomfort (p0.0018); redness (p0.016); excessive blinking (p0.001); and overall ocular discomfort (p0.001). Investigator and subject global assessments demonstrated greater improvement in the treatment (p0.001) 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.

[Guest]

Thanks for posting the abstract... I have a few questions though if you have the time...

Have there been studies done on your product on much larger numbers of patients?

Is the full article on your study available anywhere to read? or only the abstract? (As I'm sure you can appreciate, one can often get a lot more insight into the study results when the complete details of the study are available to read)

Also, I'm wondering which exact products were used in the study, and what exactly do they contain? It says:
"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."

Are the "Eye Enhancer" capsules referenced in the abstract the same as your "TheraLife Eye Enhanced" that I see on your website? If so, what are the TheraLife Eye Capsules then? What do they contain?

On your website, when I click on TheraLife Eye Enhance, I can see that it is a vitamin/mineral supplement with herbs added to it... it shows the following for active ingredients per 2 capsules:

Beta-Carotene 12500IU, Vitamin E 180IU, Ascorbic Acid 200mg, Riboflavin 10mg, Zinc 20mg, Copper 1mg, Selenium 67mcg, L-Carnitine 100mg, Proprietary herbal blend Fructus lycii, Bilberry, Chrysanthemum, Notoginsheng
867mg

So what is the Theralife Eye that was taken for the full 4 weeks then? Is it just a fish oil supplement??? or something else?

Thanks again!

[Pegasus]

What is in TheraLife Eye

This is the phase II clinical trial done on TheraLIfe Eye plus numerous animal studies. We have not launched a Phase III clinical trial which will require a much larger population and then proceed for FDA drug approval. We did post the entire article on our web site, however, not too many people read it, so we took it off. Perhaps we should consider re-posting it.

The key reason why TheraLife Eye capsules work is due to the priprietary herbal blend, which is patent protected. The vitamins and minerals help to accelerate the delivery of dry eye relief.

Here is a web link to the ingredients in TheraLife Eye and what each components functions are. http://www.theralife.com/WhatisinTheraLifeEye.html

For ease sake. I am posting the content here.

What is in TheraLife® Eye Enhanced?

Ingredients:
Beta-Carotene An antioxidant that can be converted into Vitamin A, which is crucial for healthy eyes, bones, hair and skin. It protects the brain cells from free radical damage, and maintains eye structures such as the retina.

Vitamin E It protects cell membranes, proteins, fats, and Vitamin A from destructive oxidation. Vitamin E preserves Vitamin A in the eyes, protects red blood cells, and boosts the nervous system and immune system.

Ascorbic Acid (Vitamin C) An antioxidant that inhibits the formation of nitrosamines (a suspected carcinogen). Vitamin C helps to maintain bones, teeth, hair, nails, and blood vessels. Works together with Vitamin E and Beta Carotene to deactivate free radicals.

Riboflavin (B 2) This vitamin is necessary for healthy eyes and skin.

Zinc A mineral that is important in healing wounds.

Copper Required for red blood cell and hemoglobin formation and acts in enzyme systems.

Selenium An antioxidant that stabilizes vitamin E.

L-Carnitine This vitamin increases circulation and metabolism in the body.

Fructus Lycii Known as the "eye-brightening herb", it is used for poor eyesight, eyestrain, cataracts, glaucoma, and other eye disorders. The fruit provides antioxidant protection for the eyes against free radicals.

Billberry This herb helps the eyes and cardiovascular system by stimulating and increasing overall circulatory health.

Chrysanthemum This is an "eye-brightening herb" that is often used in conjunction with Fructus Lycii to treat eye conditions. It improves blood circulation,helps reduce inflammation and irritation

Notoginsheng Notoginseng is used to for wounds and soft tissue injuries. It aids the healing of wounds, bruises, and improves blood flow.

TheraLife® Eye Enhanced
These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

The table format is not retained when I did the copy and paste. However, you can see the entire list at the web site

[Guest]

Hi!

I appreciate your taking the time to answer. I'm still wondering what exactly the 2 products are that were used in the abstract you mentioned...

The abstract says:
"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."

I had already seen the list of ingredients on your website for the ""Theralife Eye Enhanced" that you posted the link to... however, your abstract references not ONE, but TWO separate supplements.... I'm still wondering what the other supplement was...

If you ever decide to re-post the study in its entirety, I'd be very interested in checking it out.

Thanks again!

[spmcc]

RE: published study results

I'm really interested in study results published in peer-reviewed journals. The peer-review process helps ensure that authors have met basic standards in their research and interpretations. Also, I prefer that authors state their conflicts of interest. These statements are required by reputable journals.

[Pegasus]

TheraLife Eye Clinical Trial Results- 2 product question

Hi:

Very good question. In the early days when we were conducting the TheraLife Clinical Trial, 2 products were used, one called TheraLife Eye, the other called TheraLife Enhanced. The reason is, there are other TheraLife products the company was developing which required the Enhanced part of the formula.

Currently, these 2 products are combined into one- called TheraLife Eye Enhanced. No more 2 products. The ingredients list for TheraLife Eye is the combined formula.

The Enhanced portion of the formula is strongly anti-inflammatory, anti- oxidation and provided pain relief- beneficial to most of the patients who has chronic severe dry eyes.

Yes, I will try to post the entire publication on the web. Will let you know when it is done.

Thank you for taking the time to study and read this information. Our most successful customers are the ones who learn, and help manage their own health.

[Guest]

Thanks for the clarification!

[Gram]

Any feedback in 2016 about TheraLife Enhanced efficacy for severe dry eye with atrophied meibomium glands?