How are NIGHT & DAY contact lenses different?

NIGHT & DAY contact lenses are the first lenses available in the United States with a wearing indication for continuous wear for up to 30 night's continuous wear. NIGHT & DAY also allows six times more oxygen to reach the cornea than ordinary disposable or reusable lenses even when eyes are closed during sleep. As a result, the lenses allow the eyes to breath, which means clear and comfortable vision correction 24 hours a day.

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What does the FDA approval of NIGHT & DAY mean for the contact lens industry?

This is one of the most significant events in contact lens history, since soft lenses were introduced more than 30 years ago. It is also an important advancement for people who need vision correction. We anticipate NIGHT & DAY lenses popularity in the US will grow, because this breakthrough product delivers what many individuals want: the ability to have comfortable, clear vision around the clock in a convenient way that easily fits with their busy and unpredictable lifestyles.

NIGHT & DAY also is a good alternative to laser vision surgery for the millions of individuals who are not good candidates for the procedure and/or who are averse to it due to its high costs, invasiveness, irreversibility and potential complications.

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Why create lenses designed to be worn while sleeping?

We know that patients consistently tell their eye care practitioners that they want safe, convenient, around-the-clock vision. Our research confirms that patients want a lens that is safe to wear while sleeping. NIGHT & DAY provides oxygen transmission even during sleep making it the most convenient lens on the market today. NIGHT & DAY lenses eliminate the tedious daily hassles of inserting, removing and cleaning lenses. The lenses can be worn for up to 30 continuous nights and days, and can be easily discarded and replaced with a new pair.

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What is the indication for NIGHT & DAY contact lenses?

NIGHT & DAY soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to approximately 1.50 diopters of astigmatism

The lenses may be prescribed for daily wear or for continuous wear for up to 30 nights of continuous wear, with removal for disposal, or cleaning and disinfection prior to reinsertion (as recommended by your eye care professional).

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Do NIGHT & DAY contact lenses require any cleaning or disinfection?

NIGHT & DAY lenses do not require daily cleaning or disinfection when worn continuously for up to 30 days. However, lenses removed between replacement times must be cleaned and disinfected with a chemical, non- heat, disinfection system before reinsertion. People should carefully follow the wear and replacement recommendations of their eye care professional.

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How is NIGHT & DAY packaged for purchase?

NIGHT & DAY contact lenses will be sold in packages of six.

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What is silicone hydrogel?

NIGHT & DAY lenses are made of a revolutionary, new silicone hydrogel material. The unique molecular structure of this material has two distinct pathways that allow water to pass through the lens without reducing its ability to transmit oxygen to the eye. This enables the lens to move freely on the eye and to keep plenty of oxygen flowing to the cornea.

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What dimensions (parameters) are NIGHT & DAY available in?

NIGHT & DAY lenses are available in an 8.6mm and 8.4mm base curve with a 13.8mm diameter. The lens power range will include +0.25D to +6.00D in 0.25D steps, -0.25D to -8.00D in 0.25D steps and -8.50D to -10.00D in 0.50D steps.

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How much do NIGHT & DAY lenses cost?

Pricing is set by eye care practitioners rather than CIBA Vision. But the lenses are generally priced competitively with ordinary contact lenses (combined with lens care solutions) currently sold. The typical range is from US$250 to US$320 a year - or US$21 - US$27 a month.

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Are NIGHT & DAY contact lenses safe?

Both our clinical research and market experiences have shown that NIGHT & DAY lenses can be worn safely for up to 30 continuous nights and days.

NIGHT & DAY is one of the most thoroughly researched contact lenses in history. We have amassed more than 2,000 patient years of clinical study in the U.S. with 483 patients having worn NIGHT & DAY for more than a year.

The lenses enable sufficient oxygen to reach the eye even during sleep, help minimize deposit buildup on the surface over time and wet easily, which helps them move well on the eye. NIGHT & DAY lenses allow the eyes to breath by delivering up to six times more oxygen to the eye-the highest in the industry ? than ordinary soft contact lenses.

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Do people experience red eyes after wearing these lenses?

Red eyes can be a sign that the eyes are not receiving enough oxygen. Patients typically don't experience red eyes with NIGHT & DAY. Because the lenses are made of a highly oxygen transmissible material, sufficient oxygen reaches the eye, even during sleep. In research studies, NIGHT & DAY wearers experienced less limbal redness than people who wear ordinary disposable lenses did. Also patients and practitioners also frequently comment on how white their eyes are while wearing NIGHT & DAY lenses.

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Do NIGHT & DAY contact lenses stick to the eye?

No. The unique molecular structure of the contact lens has two distinct pathways that allow water and oxygen to pass through to the eye without reducing its ability to transmit oxygen. This enables the lens to move freely on the eye and to keep plenty of oxygen flowing to the cornea.

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Why is it important for oxygen and water to pass through the lens to the eye?

Oxygen is essential for corneal health. Insufficient oxygen compromises normal eye function and may cause cornea swelling, which leads to irritated, red eyes and uncomfortable lens wear. While minimal swelling is common during sleep (even in people who do not wear contact lenses), sleeping in ordinary lenses substantially reduces oxygen supply to the eyes.

NIGHT & DAY contact lenses supply ample oxygen to the cornea, even during sleep. In fact, they provide six times more oxygen to the eye than ordinary soft contact lenses and 40 percent more oxygen than the minimum threshold recognized by independent researchers for overnight wear of contact lenses. In research studies, users wearing NIGHT & DAY lenses experienced minimal swelling similar to those wearing no lens at all and significantly less eye redness than is typically seen with soft contact lens wear.

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What makes these lenses different from other continuous wear lenses?

NIGHT & DAY is different because it can be worn for up to 30 nights and days of continuous wear and allows more oxygen to reach the cornea than ordinary, soft lenses, even when eyes are closed. In fact, NIGHT & DAY lenses provide up to six times more oxygen to the eye than ordinary soft contact lenses.

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What are other possible side effects of continuous wear lenses?

An inflammation of the cornea called infiltrative keratitis is another potential side effect. During the one-year U.S. study about 5% of the 1,300 eyes experienced this type of side effect. Other less serious side effects were conjunctivitis and lid irritation or discomfort while wearing the lenses, including dryness of the eye and mild burning or stinging.

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Was research done on NIGHT & DAY contact lenses?

NIGHT & DAY lenses are some of the most thoroughly researched contact lenses in history. CIBA Vision has amassed more than 2,000 patient years of clinical study prior to its introduction into the United States. NIGHT & DAY has FDA approval for up to 30 night continuous wear. Our most recent FDA clinical trial in the U.S. involved 1,395 patients who were seen at 59 different investigational locations throughout the country. The trial was strictly a safety and efficacy study and was conducted over the course of one year.

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How was NIGHT & DAY developed?

NIGHT & DAY is the result of an international collaboration involving scientists from CIBA Vision, as well as researchers from the Cooperative Research Centre for Eye Research and Technology (CRCERT) in Australia and Novartis in Switzerland. CIBA Vision brought together the best minds from a range of disciplines: polymer chemists, academic researchers, material scientists, process engineers, physicists, clinicians and marketing and regulatory specialists worked together from laboratories and research centers in Atlanta, Switzerland and Australia.

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What were the results of the clinical study?

Our U.S. clinical study showed that NIGHT & DAY lenses can be worn safely for up to 30 continuous nights and days. A number of wearers also felt the lenses were less dry than ordinary soft contact lenses. These findings combined with the convenience and freedom of around-the-clock clear vision make NIGHT & DAY a desirable solution for many individuals in need of vision correction.

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Do you plan to conduct a post-approval study?

Yes. We are interested in monitoring the performance of our products through post-approval studies. Also a post-approval study is a condition of FDA approval of NIGHT & DAY.

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Have you determined the protocol for the post-market approval study?

Yes. The FDA has approved the protocol. We will conduct a study over the next two years that will involve several thousand individuals wearing NIGHT & DAY for a year. We anticipate that nearly 100 eye care professionals from cities throughout the United States will be involved in the study. Practicing eye care professionals will collect the data, and a review board of independent, ophthalmic research experts will oversee the data analysis.

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What were the results of the clinical study?

Our clinical studies show that patients wearing NIGHT & DAY experience minimal complications. In addition since 1999, hundreds of thousands of patients worldwide have worn NIGHT & DAY for up to 30 continuous nights and days. Both our clinical research and market experiences have shown that NIGHT & DAY can be worn safely. As with all contact lenses, following instructions and seeking routine eye care from a practitioner are important aspects of successful contact lens wear.

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What complication rates have you experienced with NIGHT & DAY?

Oxygen permeability (Dk) refers to the lens material's ability to convey oxygen. Oxygen transmissibility (Dk/t), a more relevant measure for contact lenses, takes into account the material's oxygen permeability and its thickness, factors that affect the amount of oxygen that can pass through the lens to the eye.

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What is an acceptable rate for adverse effects with contact lenses approved for up to 30 nights and days of continuous wear?

Obviously the less issues the better. Our benchmark for NIGHT & DAY lenses was for the lenses, when worn for up to 30 continuous nights and days, to perform comparatively to continuous wear lenses currently on the market worn for six nights continuous wear.

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Why is NIGHT & DAY a good alternative to LASIK?

Many patients are not good candidates for LASIK surgery because of the shape of their eyes, size of their pupils or even because of the amount of vision correction they need. Many individuals also are averse to the surgery due to its high costs, invasiveness, non-reversibility and potential complications.

NIGHT & DAY contact lenses also can provide individuals comfortable, around-the-clock, clear vision, but unlike laser vision surgery it is a reversible, non-invasive and less costly option.

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How does NIGHT & DAY compare with Bausch & Lomb's PureVision lens?

NIGHT & DAY is superior in oxygen transmissibility, allowing over 60 percent more oxygen to reach the eye than ordinary contact lenses. NIGHT & DAY has an oxygen transmissibility of 175 Dk/t, while our competitor reports that their lens only has an oxygen transmissibility of 110 Dk/t. This level of oxygen transmissibility is less than the minimum threshold of 125 Dk/t recognized by independent researchers for overnight wear of contact lenses to avoid stromal hypoxia, or stress to the eye.

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