SUMMARY OF SAFETY AND EFFECTIVENESS DATA

I. [GENERAL INFORMATION]{.underline}

Device Generic Name: lotrafilcon A hydrophilic contact lens

Device Trade Name: Focus^R^ Night and Day^TM^ (lotrafilcon A)

soft contact lens

Applicant's Name and Address: CIBA Vision Corporation

########  11460 Johns Creek Parkway

#########  Duluth, GA 30097

####### Date(s) of Panel Recommendation: None

Premarket Approval Application (PMA) P000030

Number:

Date of Good Manufacturing Inspection: July 12 and September 27, 2001

Date of Notice of Approval to Applicant: October 12, 2001

II\. [INDICATIONS FOR USE]{.underline}

> Focus^R^ Night and Day^TM^ (lotrafilcon A) 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 1.5 diopters of astigmatism.
>
> The lenses may be prescribed for extended wear for 1 to 7 days between
> removals for cleaning and disinfection or disposal of the lens, as
> recommended by the eye care professional. Lenses should be replaced
> every month and when removed between replacement times must be cleaned
> and disinfected with a chemical, not heat, disinfection system before
> reinsertion.
>
> (The Focus^R^ Night and Day^TM^ (lotrafilcon A) soft contact lens was
> cleared for Daily Wear under K970746 on May 9, 1997).

III\. [CONTRAINDICATIONS]{.underline}

> Do not use Focus^R^ Night and Day^TM^ (lotrafilcon A) soft contact
> lenses when any of the following exists:

-   Inflammation or infection of the anterior chamber of the eye

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-   Active disease, injury or abnormality affecting the cornea,
    conjunctiva, or eyelids

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-   Microbial infection of the eye

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-   Insufficiency of lacrimal secretion (dry eye) that interferes with
    contact lens wear

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-   Corneal hypoesthesia (reduced corneal sensitivity)

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-   Use of any medication that is contraindicated or interferes with
    contact lens wear, including eye medications

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-   Any systemic disease which may be exacerbated by or interferes with
    contact lens wear

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-   Allergic reactions of ocular surfaces or adnexa that may be caused
    by or exaggerated by wearing contact lenses

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-   Allergy to any ingredient in a solution which must be used to care
    for the contact lenses

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-   Patient history of recurring eye or eyelid infections, adverse
    effects associated with contact lens wear, intolerance or abnormal
    ocular response to contact lens wear

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-   If eyes become red or irritated

IV\. [WARNINGS AND PRECAUTIONS]{.underline}

> The warnings and precautions can be found in the Focus^R^ Night and
> Day^TM^ (lotrafilcon A) soft contact lens labeling (Attached)

V. [DEVICE DESCRIPTION]{.underline}

> Focus^R^ Night and Day^TM^ (lotrafilcon A) soft contact lenses are
> available in a spherical lens design. The lens material is
> approximately 24% water and 76% lotrafilcon A, a fluorosilicone
> containing hydrogel which is surface treated. The lens may be
> prescribed for extended wear in powers ranging from +20.00 D to
> --20.00 D.

VI\. [ALTERNATIVE PRACTICES AND PROCEDURES]{.underline}

> The alternative practices and procedures to correcting vision by
> wearing the Focus^R^ Night and Day^TM^ (lotrafilcon A) soft contact
> lens include other daily wear and extended wear contact lenses, rigid
> gas permeable daily wear and extended wear contact lenses, spectacles,
> and corrective surgeries such as radial keratotomy, photorefractive
> keratectomy and LASIK.

VII\. [MARKETING HISTORY]{.underline}

> United States
>
> To date, Focus^R^ Night and Day^TM^ (lotrafilcon A) soft contact
> lenses have not been marketed in the United States.
>
> International
>
> Focus^R^ Night and Day^TM^ (lotrafilcon A) soft contact lenses bear
> the CE mark and were introduced to the world market in early 1999 for
> use up to 30 nights extended wear. The lens has over 250,000 users and
> is marketed in over 40 countries. The Focus^R^ Night and Day^TM^
> (lotrafilcon A) soft contact lens has not been withdrawn from
> marketing for any reason relating to the safety and effectiveness of
> the device.

VIII\. [POTENTIAL ADVERSE EFFECTS OF THE DEVICE ON HEALTH]{.underline}

> Potential adverse effects on health associated with extended wear
> contact lenses include eye problems such as corneal ulcers, epithelial
> microcysts, infiltrates and endothelial polymegathism. The risk of
> corneal ulcer has been shown to be greater among users of extended
> wear contact lenses than among users of daily wear contact lenses. The
> risk among extended wear users increases with the number of
> consecutive days that the lenses are worn between removals, beginning
> with the first overnight use. In addition, smoking increases the risk
> of corneal ulcers for contact lens users, especially when lenses are
> worn overnight or while sleeping. Strict compliance with the proper
> lens care regimen and wearing schedule is essential in minimizing
> risk.

IX\. [SUMMARY OF PRECLINICAL STUDIES]{.underline}

> The objective of the preclinical studies was to provide reasonable
> assurance of the safety of the Focus^R^ Night and Day^TM^ (lotrafilcon
> A) soft contact lens prior to clinical testing.
>
> Biocompatibility Studies
>
> The following toxicology tests were performed: USP Systemic Injection
> Test, Primary Ocular Irritation Test, Cytotoxicity Test (USP L929 Agar
> Overlay, Direct Contact and MEM Elution Assays, and ISO Cell Growth
> Inhibition Assay), Guinea Pig Maximization Test, 28 Day Ocular
> Irritation Test, and Leachables Testing. The test results raise no
> acute toxicological concerns and support the safety of the study lens
> for its intended use.
>
> *Physical and Chemical Characterization Studies:*

\% Water Content 24 % by weight in normal saline

Oxygen Permeability (Dk): 140 X 10^-11^ (cm^2^/sec)(ml O~2~/ml x mm Hg)

(measured at 35^o^ C Coulometric method)

\% Light Transmittance [\>]{.underline} 99%

Mechanical Properties:

Young's modulus of elasticity (Mpa) 1.2

Stress at break (mpa) 0.8

\% Maximum Elongation 150

Toughness at break (mJ/cm^2^) 764

Refractive Index: 1.43

> *Solution Compatibility Studies:*
>
> Cycling studies were performed using the following care products:
> AOSEPT Regimen, Quick Care Regimen, Focus Lens Drops, Optifree and
> ReNu Preservative Uptake and release studies were performed for
> polyquad, sorbic acid and PHMB. All lens care systems were compatible
> with the Focus^R^ Night and Day^TM^ (lotrafilcon A) soft contact lens.
>
> Shelf-life Stability Studies
>
> An expiration date of 60 months has been established for sterilized
> lenses packaged in foil sealed blister packs.
>
> *Conclusion of Preclinical Studies:*
>
> The results of the preclinical studies support the safety of the
> Focus^R^ Night and Day^TM^ (lotrafilcon A) soft contact lens for its
> intended use.

X. [SUMMARY OF CLINICAL STUDIES]{.underline}

> **Objective**

The objective of this clinical trial was to determine whether the
Focus^R^ Night and Day^TM^ Lens, when worn for up to one week extended
wear and replaced on a monthly basis, performed as well as or better
than the Control lens, when worn for up to one week extended wear and
replaced on a weekly basis.

**Study Design**

> This clinical trial was a prospective, randomized, controlled, open
> label clinical trial lasting one year. A total of 450 subjects (305
> test and 145 control) were enrolled at 20 investigational sites
> throughout the United States. Approximately fifteen test and eight
> control subjects were to be enrolled at each site. Subjects were
> randomized to wear either the test or control lens bilaterally for one
> year.

For the purposes of this study, extended wear meant that lenses were to
be applied and worn around the clock, including during sleep. Weekly
extended wear meant at the end of any six (6) nights of extended wear,
the patient had to remove the lens for one night prior to beginning a
new cycle of lens wear. All subjects used the AOSEPT ^R^ system as the
primary care regimen when lenses were removed.

Baseline characteristics and demographics were summarized using
descriptive statistics such as means, proportions, and standard
deviations. The primary safety endpoint analysis was based on the
proportion of subjects in each group who developed corneal infiltrates
with overlying fluorescein staining and/or grade 3.0 corneal infiltrates
if no overlying staining was present. To guard against bias, the dropout
rates for each group were compared. A Cox Model was used to consider all
data from all subjects (including dropouts). The Cox Model involves
using life table methods to incorporate the exposure

time of the discontinued subjects. The primary efficacy endpoint
analysis was based on the proportion of subjects in each group able to
successfully maintain the extended wearing schedule. This was calculated
using the percent of participants that reported at least 6 consecutive
nights of lens wear at the 1, 3, 6, 9, and 12 month visits.

> Other primary safety data collected during the study included:

-   Adverse events

-   Discontinuations

-   Biomicroscopy

-   Subjective symptoms and problems

-   Keratometric and refractive changes

-   Best-corrected acuity

> The primary efficacy data collected during the study included:

-   Wearing time and temporary interruptions of lens wear

-   Contact lens visual acuities (Snellen)

> Subjects were eligible for study participation if they were at least
> 18 years old, signed informed consent, and complied with inclusion and
> exclusion criteria specified in the protocol. These criteria permitted
> inclusion of subjects who needed correction in both eyes that was
> correctable to a distance visual acuity (VA) of 20/40 or better in
> each eye with spherical hydrogel contact lenses and excluded subjects
> with conditions that would interfere with efficacy and safety
> assessments or expose the subject to an unacceptable risk. Pregnant or
> lactating women were included in the study as these individuals
> comprise a significant portion of the contact lens wearing population.
>
> The study population consisted of subjects representative of the
> general population attending offices for contact lens care. Of the
> subjects enrolled, 290 test and 145 Control subjects were dispensed
> lenses. The study population ranged in age from 18 to 61 years (Test
> mean=34 years, Control mean = 33 years). Lens power ranged from --1.00
> D to
>
> --6.50 D (Test mean = -3.23 D, Control mean = -3.41 D). Only 26
> subjects were neophyte lens wearers. Previous experience was
> considered to be successful for 404/409 (98.8%) of subjects who
> reported prior lens wear.
>
> Gender distribution consisted of 66% (191) females in the Focus^R^
> Night and Day^TM^ group and 76% (111) females in the Control group.
> Although each distribution can be considered representative of the
> contact lens wearing population, the difference is statistically
> significant. The statistical difference would be lost if just 3 more
> male subjects and 3 fewer females were enrolled in the Control group.
> The randomization was done within site and there were no significant
> differences in the gender distribution by site. However, 15 of the 20
> sites had a higher proportion of females in the Control group compared
> to the Focus Night and Day group. There was no evidence of any
> violation in the randomization process that would explain this
> difference.
>
> **Subject Assessments**
>
> At each study visit, subjects were given enough lenses to last until
> the next study visit, allowing for scheduled and unscheduled lens
> replacements. All other visits for any reason were recorded as
> Unscheduled Visits. Whenever possible, subjects were evaluated toward
> the end of the lens replacement cycle. Subjects were allowed to use
> their Focus Night and Day lenses for up to 35 days before replacement
> to assure that this was possible. Follow-up visits were scheduled for
> 24 hours, 1 week, and 1, 3, 6, 9, and 12 months after starting
> extended wear.

Adverse events were defined as any undesirable clinical occurrence in a
subject whether it was considered to be device related or not. Adverse
events were classified as adverse device effects, undesirable side
effects, or other serious adverse events according to criteria specified
in the protocol.

> Discontinuations could be due to a variety of reasons such as best
> interest of the patient, voluntary withdrawal by the subject, protocol
> deviations, lack of follow-up (lost-to-follow-up = 2 consecutive
> visits missed), relocation, neophytes who had not initiated extended
> wear within 45 days of enrollment, and if subjects switched from
> extended to daily wear indefinitely. Completion was defined as wearing
> the test or control lenses for 12 months after initiation of extended
> wear and the subject had the required evaluations performed.
>
> **Demographic Data**
>
> The dispensed study population ranged in age from 18 to 61 years (mean
> = 33-34 years. Gender distribution consisted of 66% (191) females in
> the Focus Night and Day group and 76% (111) females in the Control
> group.
>
> **Data Analysis and Results**
>
> Adverse events were defined in the protocol as Adverse Device Effects
> (ADE) and Undesirable Side Effects (USE). Table 1 shows the number and
> percentage of adverse reactions, USEs, and any other treatments for
> each treatment group.

**Table 1: Summary of Adverse Reactions, USEs, and Any Treatment**

**Completed Discontinued**

**\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**

> **Focus EW Lens Control EW Lens Focus EW Lens Control EW Lens**
>
> **N % N % N % N %**

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**Sample Size**

Subjects 235 100% 130 100% 55 100% 15 100%

Eyes 470 100% 260 100% 110 100% 30 100%

**One or More Adverse Reactions**

Subjects 0 0.0% 1 0.8% 0 0.0% 1 6.7%

Eyes 0 0.0% 1 0.4% 0 0.0% 1 3.3%

**One or More USEs**

Subjects 32 13.6% 19 14.6% 7 12.7% 5 33.3%

Eyes 49 10.4% 27 10.4% 13 11.8% 7 23.3%

**Any Treatment**

Subjects 14 6.0% 8 6.2% 4 9.1% 0 0.0%

Eyes 25 5.3% 10 3.8% 6 5.4% 0 0.0%

No Adverse Device Effects were reported for the Focus Night and Day
lenses. Two (2) cases of Adverse Device Effect were reported for the
Control lens. Subject 15-015 was diagnosed with infiltrative keratitis
and secondary iritis in the left eye; subject 17-005 was diagnosed with
an infectious ulcer in the left eye. Neither subject had permanent loss
of vision. A total of 49 completed eyes in 32 subjects in the Focus
Night and Day group experienced one or more USE's (undesirable side
effects) as compared to 27 completed eyes in 19 subjects in the Control
group.

Although Contact Lens Acute Red Eye (CLARE) was a possible diagnosis in
this protocol, many practitioners did not follow the definition of CLARE
as outlined in the protocol. Because of the practitioner confusion
regarding the definition, CLARE is not used as a diagnosis in the final
analysis of the data. CIBA Vision has reclassified subjects diagnosed
with CLARE based on the documented signs and symptoms reported on the
CRF. If infiltrates were present, the diagnosis of Infiltrative
Keratitis was used. If no infiltrates were present, the event was
classified based on the most severe biomicroscopy/symptom recorded.
Seven out of a total of eleven diagnosed

> CLARE events did not have the presence of infiltrates as required by
> the definition. Four of these seven subjects had grade 2 or less
> limbal and/or bulbar redness with only minimal or moderate symptoms.
> There were 4 cases of CLARE reported for the Control lens. The test
> lens, Focus Night and Day, reported 8 cases.
>
> The percentage of completed subjects who received any treatment other
> than for an ADE or USE (including temporary interruption of lens wear)
> was similar for Focus Night and Day (6.0%) and Control (6.2%) lens
> wearers. For discontinued subjects, any treatment was provided to four
> (9.1%) discontinued Focus Night and Day subjects, but no discontinued
> Control subjects. The types of conditions treated were similar for the
> two treatment groups.
>
> The percent of subjects discontinued is based on the number of
> subjects dispensed. Overall, 55 (19.0%) of Focus Night and Day
> subjects and 15 (10.3%) Control subjects discontinued from the trial.
> Focus Night and Day had a higher discontinuation rate due to
> discomfort and fit. The Focus Night and Day lens was only available in
> one design (8.6/13.8) during this trial. Control was available in two
> base curves (8.4 and 8.8 mm). Forty-two percent (42%) were dispensed
> with the 8.4mm base curve and the remaining lenses were dispensed with
> the 8.8 mm base curve. Although approximately 97.9% of the dispensed
> Focus Night and Day group achieved an acceptable fit rating by the
> investigators, an inadequate fit may also be judged by subjective
> reports of lens awareness or by observation of edge lift. Of the 27
> subjects discontinued for discomfort, 23 (85%) discontinued within one
> week of dispensing. This indicates that the discomfort was present
> very early in the trial and likely due to a less than optimal fit.

### *Slit Lamp Findings:*

Slit lamp findings are presented in Table 2 for completed subjects.
Grade 0 slit lamp findings were reported for 89.8% of the Focus Night
and Day and 88.3% of the Control lens wearers for all subjects and all
visits. Completed subjects with Grade 3 had a rate of 0.2%; whereas, a
rate of 0.1% was recorded for discontinued subjects. A mild trend was
shown for Focus Night and Day to have a higher percentage of Grade 0
biomicroscopy findings for neovascularization, microcysts, and striae.
This was attributed to the oxygen permeability profile of the Focus
Night and Day material. Focus Night and Day also showed less limbal and
bulbar redness.

##### 

##### 

##### 

##### 

##### Table 2. Slit Lamp Findings (Completed Subjects)

> **\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**
>
> **Focus Control**
>
> **\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_[N&D]{.underline}\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**

###### limbal Redness

Grade 0 91.3% 87.0%

> Grade 1 7.9% 12.0%

Grade 2 0.4% 0.9%

Grade 3 0.1% 0.2%

Grade 4 0.0% 0.0%

**Bulbar Redness**

> Grade 0 85.8% 84.5%
>
> Grade 1 12.9% 14.3%

Grade 2 1.0% 1.0%

Grade 3 0.1% 0.1%

Grade 4 0.0% 0.0%

**Palpebral Redness**

Grade 0 91.9% 90.2%

> Grade 1 7.2% 9.5%

Grade 2 0.6% 0.2%

Grade 3 0.0% 0.1

Grade 4 0.0% 0.0

**Epithelial Staining**

Grade 0 82.2% 82.2

> Grade 1 16.2% 16.0

Grade 2 1.3% 1.3

Grade 3 0.0% 0.0

Grade 4 0.0% 0.0

###  Tarsal Abnormalities

Grade 0 84.8% 84.9%

> Grade 1 12.5% 13.5%

Grade 2 2.4% 1.5%

Grade 3 0.1% 0.0%

Grade 4 0.0% 0.0%

###  

> **\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**
>
> **Focus Control**

### \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_[N&D]{.underline}\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

### Conjunctival Staining

Grade 0 85.8% 82.6%

> Grade 1 13.0% 16.0%

Grade 2 0.9% 1.3%

Grade 3 0.0% 0.0%

Grade 4 0.0% 0.0%

> **Vascularization**

Grade 0 91.2% 87.9%

> Grade 1 8.1% 11.6%

Grade 2 0.4% 0.5%

Grade 3 0.0% 0.0%

Grade 4 0.0% 0.0%

**Microcysts**

Grade 0 94.7% 90.9%

> Grade 1 4.4% 8.8%

Grade 2 0.7% 0.3%

Grade 3 0.0% 0.0%

Grade 4 0.0% 0.0%

**Striae/Edema**

Grade 0 98.9% 95.1%

> Grade 1 0.8% 4.3%

Grade 2 0.0% 0.5%

Grade 3 0.0% 0.1%

Grade 4 0.0% 0.0%

**Infiltrates**

Grade 0 99.1% 98.9%

> Grade 1 0.3% 0.5%

Grade 2 0.3% 0.5%

Grade 3 0.0% 0.0%

Grade 4 0.0% 0.0%

**Other**

Grade 0 95.5 % 96.1%

> Grade 1 4.0% 2.3%

Grade 2 0.3% 1.6%

Grade 3 0.0% 0.0%

Grade 4 0.0% 0.0%

The primary safety endpoint established for this clinical investigation
was corneal infiltrates with any overlying staining and/or infiltrates
\>Grade 2. A total of 12 (4.1%) Focus Night and Day and 14 (9.6%)
Control subjects had infiltrates throughout the clinical trial. Of
these, 3.4% (10) and 5.5% (8) Control subjects had corneal infiltrates
Grade 2. A life table analysis revealed that Focus Night and Day had a
clinical trend towards being slightly better than the Control; however,
this observation could not be proven to be statistically significant.
For all infiltrates, with or without overlying staining, the life table
analysis showed Focus Night and Day to perform both clinically and
statistically better than the Control.

### *Symptoms/Problems/Complaints:*

Focus Night and Day and Control performed similarly with respect to
subject reported symptoms, problems and complaints. The most frequently
reported symptom was dryness with an incidence rate of 21.3% and 14.6%
for completed and discontinued subjects respectively in the Focus Night
and Day group. The rates for completed and discontinued subjects in the
Control group were 25.0% and 23.9% respectively. Discontinued subjects
in the Control group had higher rates of complaint regarding dryness
(23.9%) as compared to the Focus Night and Day group, 14.6%. Focus Night
and Day had higher rates of lens awareness and discomfort that were
probably related to the limited range of base curves available as
compared to Control.

> *Keratometric/Refractive Changes:*

Keratometric (K) readings were relatively stable as compared to baseline
readings. The mean change was +0.01D. The completed Focus Night and Day
eyes had a slight mean reduction (flattening) in corneal curvature of
--0.21D. There were 15 (2.6%) Focus Night and Day eyes and 4 (1.4%)
Control eyes that exhibited increase in K-readings of \>1.0 diopters.
The maximum change was \<2.0D for both test and control groups. The
changes of \>1.0D in the test lens all resulted in corneal flattening,
not steepening. It appears that the majority of these changes are the
results of the correction of corneal warpage observed at baseline in
patients that had been wearing low Dk lenses. Review of the keratometric
change data does not reveal any clinically measured disparities by
primary meridian. Additionally, there were very few K-reading changes
greater than 1.0D.

Control eyes tended to increase in myopia by an average of --0.14D for
completed subjects over the one-year trial. Focus Night and Day subjects
showed a hyperopic shift of +0.08. Two Control and three Focus Night and
Day eyes had refractive error change greater than 1.0D. These changes
were --1.75D and --2.50D in Control and approximately +1.25D in the
three Focus Night and Day eyes.

*Visual Acuity:*

Visual acuity showed that the test and control groups performed
similarly. A total of 3 (1.0%) Control and 10 (1.7%) Focus Night and Day
eyes had a reduction in acuity of greater than one Snellen line with
lenses worn at the final visit. Investigators reported that the reasons
for acuity reduction with Focus Night and Day included lens deposits and
accommodative problems from beginning presbyopia. None of the subjects
had a loss of BSCVA. In contrast, 8 (2.6%) Control and 18 (3.1%) Focus
Night and Day eyes had an improvement of more than one Snellen line of
acuity with lenses worn at the final visit. Analyses of BSCVA show
similar profiles for both test and control lens groups.

*Wear Time:*

The primary effectiveness endpoint was the percentage of subjects in
each group able to successfully maintain the extended wear schedule. For
Focus Night and Day subjects, 91.8% were able to wear lenses for 6
consecutive nights. For Control subjects, 92.9% were able to wear lenses
for 6 consecutive nights. There are no statistically significant
differences for wearing time between the two lenses.

The rates for temporary interruption in extended lens wear were similar
between the two groups. When subjects had more than one occurrence of
interrupted wear; these were counted for each occurrence. There were a
total of 27 Control instances of prescribed temporary interruptions to
contact lens wear during the trial affecting 26 subjects (17.9%). For
the Focus Night and Day lens, there were 52 Focus Night and Day
instances affecting 42 (14.5%) of the subjects. These interruptions were
temporary, changed to daily wear, or temporary cessation of lens wear
altogether.

*Other Issues:*

The Control lens was replaced weekly compared to monthly replacement of
the Focus Night and Day lens. In the Focus Night and Day group, the fit
was described as optimal, acceptably loose or tight for all but 5.2%
where the fit was rated as unacceptably loose. Front surface deposits,
back surface deposits, and front surface wetting were evaluated using a
9-point scale (0-4 in 0.5 steps) with a score of 3 or 4 representing
moderate to severe deposits or deficiency in wetting. The percentage of
eyes with a grade of 2.5 or less was 97-99% in both treatment groups for
completed eyes and 85-90% in both groups for discontinued eyes.

Subjects' opinions of the lens were rated on a scale of 1 to 10 with 10
being the most favorable outcome. The percentage of subjective ratings
of 8 was similar for both groups for completed and discontinued
subjects, with the smallest percentages for dryness and lens comfort
upon awakening. The trend analysis profile also showed similar results
between test and control lens groups.

**Conclusions Drawn from the Clinical Studies**

The data reported in this PMA application indicate that the performance
of the Focus Night and Day 7-Day extended wear lens performs as well as
the Control 7-Day extended wear lens with respect to the safety and
effectiveness endpoints established for this clinical trial. For the
primary safety and efficacy endpoints, there were no statistically
significant differences between the treatment and control groups.

XI [CONCLUSIONS DRAWN FROM STUDY]{.underline}

> The results of the preclinical and clinical studies provide reasonable
> assurance of the safety and effectiveness of the Focus^R^ Night and
> Day^TM^ (lotrafilcon A) soft contact lens for the subject population,
> refractive conditions and specified duration of wear. Although the
> potential exists for minor differences in physiological response by
> gender for the target population, minimal number of clinically
> significant findings does not indicate that gender differences are of
> clinical importance for this device.

XII\. [PANEL RECOMMENDATION]{.underline}

> In accordance with the provisions of section 515(c)(2) of the act as
> amended by the Safe Medical Devices Act of 1990, this PMA was not
> referred to the Ophthalmic Devices Panel, an FDA advisory committee,
> for review and recommendation because the information in the PMA
> substantially duplicates information previously reviewed by this
> panel.

XIII [CDRH DECISION]{.underline}

> FDA issued an approval order on October 12, 2001. The applicant's
> manufacturing facilities were inspected on July 12 and September 27,
> 2001 and were found to be in compliance with the device Good
> Manufacturing Practice regulations.

XIV\. [APPROVAL SPECIFICATIONS]{.underline}

> Directions for use: See the labeling.
>
> Hazards to Health from Use of the Device: See the Indications,
> Contraindications, Warnings, Precautions and Adverse Events in the
> labeling.
>
> Postapproval Requirements and Restrictions: See approval order.