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Most eyeglass wearers with a moderate to strong eyeglass correction have probably heard of Hi index lenses at one time or another. In the Optical industry today Hi index can

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

refer to any lens material that is thinner than the standard plastic, commonly known as CR39. In the last 10 to 15 years many new Hi index materials have been developed, ma

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

king it more confusing for the average consumer to know what is best for them.

The term Hi index is a reference to the index of refraction of a particular lens material. Th

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

e index of refraction is a measure of how much a lens material will bend or refract light. When referring to Hi index lenses, the Eye Doctor or Optician may refer to the ind

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

x of the lens. For example, Hi index 1.60 or Hi index 1.67 lenses. In general, the higher the index of a lens, the thinner it will be for a given eyeglass prescription. As

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

a point of reference, the index of a plastic CR39 lens is 1.49.

As a professional eyeglass dispenser, my recommendation for Hi index lenses is primarily determined by the st

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

rength of the eyeglass correction. For eyeglass prescriptions that are less than +/- 2.00, the benefits of hi index lenses for reducing weight and thickness are negligible.

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

Often times the added cost associated with Hi index lenses are not justified for lower corrections. If the eyeglass prescription is greater than +/- 3.00 I would normally r

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

commend a 1.60 Hi index lens. This lens material is 25 to 30% thinner that CR39 plastic and will result in a lens that is noticeably thinner and more attractive for the wear

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

er. For prescriptions that are greater than +/- 5.00 a 1.67 Hi index lens would be my lens of choice. A 1.67 Hi index lenses is 40% thinner than Cr39 plastic and works real

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

ly well in this prescription range.

The latest generation of Hi index lenses are 1.71 and 1.74 index lenses. I will often times refer to these as ultra or hyper index simpl

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

y as a means of differentiating them from the other Hi index materials. These lenses I will generally recommend to people with corrections greater than +/- 8.00. The 1.74 H

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

index lenses are nearly half the thickness of the CR39 lenses. If you are one the few people with eyeglass lenses in this range I can tell you that the cosmetic benefits of

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

the 1.74 lenses are astonishing.

In addition to being thinner, Hi index lenses also have the benefit of being natural UV blockers. Because of this it is not necessary to ad

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

d a UV protection or coating to these lenses. Hi index lenses come standard with a scratch protective coating. Some Hi index lenses also include an anti reflective coating,

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

which is very beneficial because Hi index lenses will have more glare due to the increased density of the material.

In conclusion, these recommendations are guidelines and t

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

ere are exceptions. For example, when it comes to childrens eyewear the lens material of choice is polycarbonate or trivex. These materials have a much greater impact resi

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

stance and there for are much safer. For full rimless frames, trivex or 1.67 hi index lenses are recommended. Other lenses materials are not good choices for drilling and t

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

end to break very easily in a full rimless frame. To achieve the best lens profile with a high index lens it is important to choose the smallest frame that is still cosmetic

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

ally appealing. Selecting a frame that your eyes are centered in will work the best. A frame that is too big can add thickness to a lens, especially with higher corrections

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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