National PBM Drug Monograph

Azithromycin Ophthalmic Solution (Azasite^TM^)

November 2007

VHA Pharmacy Benefits Management Service and Medical Advisory Panel

*The purpose of VACO PBM-SHG drug monographs is to provide a
comprehensive drug review for making formulary decisions.  These
documents will be updated when new data warrant additional formulary
discussion.  Documents will be placed in the Archive section when the
information is deemed to be no longer current.*

# Executive Summary:^1-7^ 

-   Azithromycin 1% ophthalmic solution is indicated for the treatment
    of bacterial conjunctivitis.

-   Azithromycin displays in vitro activity against organisms commonly
    isolated in bacterial conjunctivitis such as *Streptococcus
    pneumoniae* and *Haemophilus influenzae*. However, resistance to
    azithromycin is encountered with these pathogens as well.

-   Two pivotal, Phase III clinical trials were conducted to evaluate
    the efficacy and safety of azithromycin 1% ophthalmic solution in
    the treatment of bacterial conjunctivitis in adult and pediatric
    patients. In the clinical trial that compared azithromycin to
    vehicle, azithromycin 1% ophthalmic solution was found to be
    superior to vehicle. In the other pivotal clinical trial,
    azithromycin 1% ophthalmic solution was noninferior to tobramycin
    ophthalmic solution for treatment of bacterial conjunctivitis.

-   Azithromycin 1% ophthalmic solution appears to be well-tolerated.
    Eye irritation occurred in 1 -- 2% patients.

-   Place in therapy: Azithromycin 1% ophthalmic solution is an
    alternative to other ophthalmic preparations for the treatment of
    bacterial conjunctivitis. While azithromycin 1% ophthalmic solution
    is more expensive that other commonly utilized agents, it offers a
    less frequent dosing schedule. The differential impact that this may
    have on outcomes is unclear due to lack of adherence studies on the
    various preparations and their respective dosing regimens.

**[Introduction]{.underline}**

The purposes of this monograph are to (1) evaluate the available
evidence of safety, efficacy, cost, and other pharmaceutical issues that
would be relevant to evaluating azithromycin 1% ophthalmic solution for
possible addition to the VA National Formulary; (2) define its role in
therapy; and (3) identify parameters for its rational use in the VA.

# 

# Pharmacology

Macrolides inhibit protein synthesis by binding to the 50 S subunit of
the ribosome.

**[Pharmacokinetics]{.underline}^1^**

Azithromycin ophthalmic solution is formulated in DuraSite®, a novel,
polymer-based ocular drug delivery vehicle. The technology of DuraSite®
enables azithromycin to have gel-forming drops in an aqueous matrix
which allows for extended exposure of azithromycin in the eye. However,
the pharmacokinetics of azithromycin following ocular administration of
the ophthalmic solution has not been conducted. It is estimated that
plasma concentrations of azithromycin would be undetectable based upon
FDA-approved dosage regimen.

# Microbiology^2^

The in vitro susceptibility of azithromycin and moxifloxacin were
evaluated against pathogens obtained from 625 patients with bacterial
conjunctivitis (Table 1). These patients were enrolled in a
multi-center, phase III clinical trial throughout the US in 2006 --
2007.

**Table 1. In Vitro Activity and Resistance Rates of Azithromycin and
Moxifloxacin**

+------------------+----------+-------------+-----------+------------+
|                  | **Azithr |             | **Moxif   |            |
|                  | omycin** |             | loxacin** |            |
+------------------+----------+-------------+-----------+------------+
|                  | MIC~90~  | \%          | MIC~90~   | \%         |
|                  |          | Resistance  |           | Resistance |
|                  | (mcg/mL) |             | (mcg/mL)  |            |
+------------------+----------+-------------+-----------+------------+
| *H. influenzae*  | 4        | 76%         | 0.03      | 0%         |
| (n=145)          |          |             |           |            |
+------------------+----------+-------------+-----------+------------+
| *S. epidermidis* | \>512    | 30%         | 1         | 13%        |
| (n=69)           |          |             |           |            |
+------------------+----------+-------------+-----------+------------+
| *S. pneumoniae*  | 8        | 20%         | 0.12      | 0%         |
| (n=60)           |          |             |           |            |
+------------------+----------+-------------+-----------+------------+
| *S. aureus*      | \>512    | 50%         | 0.06      | 0%         |
| (n=21; all       |          |             |           |            |
| sensitive to     |          |             |           |            |
| methicillin)     |          |             |           |            |
+------------------+----------+-------------+-----------+------------+

# FDA Approved Indication^1^

# Azithromycin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following organisms: CDC coryneform group G, *H*. *influenzae*, *S*. *aureus*, *Streptococcus mitis* group, and *S. pneumoniae*. 

# 

# Current VA National Formulary Alternatives

Ophthalmic alternatives for treatment of bacterial conjunctivitis
include bacitracin, ciprofloxacin, erythromycin, gentamicin,
moxifloxacin (CFU), ofloxacin, sulfacetamide, tobramycin, and
combination of products such as bacitracin/polymyxin,
bacitracin/neomycin/polymyxin, polymyxin/trimethoprim, or
gramicidin/neomycin/polymyxin.

# Dosage and Administration^1^

Instill 1 drop in the affected eye(s) twice daily, eight to twelve hours
apart for the first two days and then instill 1 drop in the affected
eye(s) once daily for the next five days.

# 

# Efficacy in Pivotal, Phase III Trials

# Azithromycin Ophthalmic Solution vs. Tobramycin for Bacterial Conjunctivitis^3-5^

This pivotal, Phase III clinical trial has only been published as an
abstract. In a randomized, double-masked, clinical trial, azithromycin
1% ophthalmic solution was compared to tobramycin ophthalmic solution in
pediatrics and adults with bacterial conjunctivitis. Azithromycin 1%
ophthalmic solution was administered twice daily for first two days
followed by once daily for the remaining 3 days. Tobramycin ophthalmic
solution was administered four times daily for the entire 5 days.
Inclusion criteria included 1) Grade 1 ocular discharge 2) Grade 1
bulbar or palpebral conjunctival injection 3) ≥1 years old.

Endpoints

-   Primary efficacy endpoint: clinical resolution defined as absence of
    ocular discharge and bulbar/palpebral conjunctival injection on Day
    6.

-   Secondary efficacy endpoints:

    -   Bacterial eradication

Of the 316 patients in the per protocol population, 159 patients were
administered azithromycin and 157 patients were administered tobramycin.
Demographics were similar among treatment arms. Overall, median age was
9 years (range 1 -- 83) and approximately 54% were considered pediatrics
(1 -- 11 years).

Rates of successful clinical resolution and bacterial eradication were
similar among azithromycin-treated and tobramycin-treated patients
(Table 2). Bacterial eradication by organism was also similar among
treatment arms (Table 3). Although the methodology in assessing
compliance was not well-described in the abstract, the authors report
high adherence level in both treatment arms.

**Table 2. Clinical efficacy results in per protocol population**

+---------------------------------+-----------+-----------+-----------+
|                                 | **Azith   | **Tob     | **        |
|                                 | romycin** | ramycin** | P-value** |
+---------------------------------+-----------+-----------+-----------+
| Successful Clinical Resolution  | 127/159   | 123/157   | NS        |
|                                 |           |           |           |
|                                 | (79.9%)   | (78.3%)   |           |
+---------------------------------+-----------+-----------+-----------+
| Bacterial Eradication           | 140/159   | 148/157   | NS        |
|                                 |           |           |           |
|                                 | (88.1%)   | (94.3%)   |           |
+---------------------------------+-----------+-----------+-----------+
| Combined Successful Clinical    | 114/159   | 118/157   | NS        |
| Resolution and Bacterial        |           |           |           |
| Eradication                     | (71.7%)   | (75.2%)   |           |
+---------------------------------+-----------+-----------+-----------+

NS = not significant

**Table 3. Bacterial eradication on Day 6-7 in per protocol population**

+---------------------------------+-----------+-----------+-----------+
|                                 | **Azith   | **Tob     | **95%     |
|                                 | romycin** | ramycin** | CI**      |
+---------------------------------+-----------+-----------+-----------+
| All Gram-Positive Organisms     | 87/101    | 94/102    | (-15.3,   |
|                                 |           |           | 2.0)      |
|                                 | (86.1%)   | (92.2%)   |           |
+---------------------------------+-----------+-----------+-----------+
| *Staphylococcus aureus*         | 14/17     | 19/20     | (-37.4,   |
|                                 |           |           | 5.2)      |
|                                 | (82.4%)   | (95.0%)   |           |
+---------------------------------+-----------+-----------+-----------+
| *Streptococcus pneumoniae*      | 49/56     | 55/62     | (-13.6,   |
|                                 |           |           | 8.9)      |
|                                 | (87.5%)   | (88.7%)   |           |
+---------------------------------+-----------+-----------+-----------+
| All Gram-Negative Organisms     | 65/70     | 60/61     | (-11.7,   |
|                                 |           |           | 1.5)      |
|                                 | (92.9%)   | (98.4%)   |           |
+---------------------------------+-----------+-----------+-----------+
| *Haemophilus influenzae*        | 53/57     | 47/48     | (-12.9,   |
|                                 |           |           | 3.2)      |
|                                 | (93.0%)   | (97.9%)   |           |
+---------------------------------+-----------+-----------+-----------+

In conclusion, patients with bacterial conjunctivitis experienced
similar rates of successful clinical resolution and bacterial
eradication when treated with azithromycin 1% ophthalmic solution
compared to tobramycin ophthalmic solution.

# []{.mark}

# Azithromycin Ophthalmic Solution vs. Vehicle for Bacterial Conjunctivitis^6-7^

This pivotal, clinical trial has only been published as an abstract. In
a randomized, double-masked, parallel-group, phase III clinical trial,
azithromycin 1% ophthalmic solution was compared to vehicle in
pediatrics and adults with bacterial conjunctivitis. Azithromycin 1%
ophthalmic solution or placebo was administered twice daily for first
two days followed by once daily for the remaining 3 days. Inclusion
criteria includes 1) Clinical diagnosis of bacterial conjunctivitis 2)
Signs and symptoms \<3 days 3) ≥1 years old.

[]{.mark}

Endpoints

-   Primary efficacy endpoint: clinical resolution defined as absence of
    ocular discharge and bulbar/palpebral conjunctival injection on Day
    6.

-   Secondary efficacy endpoints:

    -   Bacterial eradication

Of the 279 patients in per protocol population, 130 patients were
administered azithromycin and 149 were administered vehicle.
Demographics were similar among treatment arms. Overall, median age was
19 years (range 1 -- 96) and approximately 40.9% were considered
pediatrics (1 -- 11 years).

Overall, azithromycin 1% ophthalmic solution achieved statistically
significant higher rates of successful clinical resolution and bacterial
eradication than vehicle (Table 4). Bacterial eradication by organism is
listed in Table 5. Ninety-seven percent of participants were fully
compliant with treatment regimens.

[]{.mark}

[]{.mark}

**Table 4**. Clinical efficacy results in per protocol population

+---------------------------------+-----------+-----------+-----------+
|                                 | **Azith   | **        | **        |
|                                 | romycin** | Vehicle** | P-value** |
+---------------------------------+-----------+-----------+-----------+
| Successful Clinical Resolution  | 82/130    | 74/149    | 0.030     |
|                                 |           |           |           |
|                                 | (63.1%)   | (49.7%)   |           |
+---------------------------------+-----------+-----------+-----------+
| Bacterial Eradication           | 115/130   | 99/149    | \<0.001   |
|                                 |           |           |           |
|                                 | (88.5%)   | (66.4%)   |           |
+---------------------------------+-----------+-----------+-----------+

[]{.mark}

**Table 5. Bacterial eradication on Day 6** in per protocol population

+---------------------------------+-----------+-----------+-----------+
|                                 | **Azith   | **        | **95%     |
|                                 | romycin** | Vehicle** | CI**      |
|                                 |           |           |           |
|                                 | **        |           |           |
|                                 | (n=130)** |           |           |
+---------------------------------+-----------+-----------+-----------+
| *Staphylococcus aureus*         | 82.6%     | 40.9%     | NR        |
+---------------------------------+-----------+-----------+-----------+
| *Streptococcus pneumoniae*      | 94.4%     | 77.8%     | NR        |
+---------------------------------+-----------+-----------+-----------+
| *Haemophilus influenzae*        | 92.3%     | 76.3%     | NR        |
+---------------------------------+-----------+-----------+-----------+

NR = not reported

In conclusion, azithromycin 1% ophthalmic solution achieved
statistically significant higher rates of successful clinical resolution
and bacterial eradication than vehicle.

# 

# Adverse Events (Safety Data)^1,^

*[Azithromycin Ophthalmic Solution vs. Tobramycin for Bacterial
Conjunctivitis^3-5^]{.underline}*

The safety and tolerability of these two ophthalmic preparations was
assessed in 743 patients. Completion of the trial occurred in 94%
(343/365) and 97.1% (367/378) of the azithromycin-treated and
tobramycin-treated patients, respectively. Of the 22 azithromycin
treated-patients who were discontinued, the reason was reported to be
adverse events (n=9; 2.5%), protocol violation (n=4; 1.1%), withdrew
consent (n=2; 0.5%), lost to follow-up (n=1; 0.3%), lack of efficacy
(n=2; 0.5%) and other (n=4; 0.5%). Of the 11 tobramycin treated-patients
who were discontinued, the reason was reported to be adverse events
(n=8; 2.1%) and withdrew consent (n=3; 0.8%).

Overall, there were 3% (11/365) treatment-emergent adverse events in the
azithromycin arm compared to 5.6% (21/378) in tobramycin arm. Refer to
Table 6 for most frequently reported ocular-related, treatment-emergent
adverse events. Worsening of visual acuity (defined as 3 lines or more
on Snellen chart) occurred in 0.8%patients in each treatment arms on Day
6. Lastly, indirect ophthalmosocopy and biomicroscopy revealed worsening
of ophthalmic signs in a limited number of patients. Twelve patients
(3.3%) in each treatment arm experienced lid swelling while chemosis
conjunctiva occurred in 8 (2.2%) azithromycin-treated patients and 10
(2.6%) tobramycin-treated patients. Staining erosion or cornea occurred
in 7 (1.9%) azithromycin-treated patients and 6 (1.6%) in
tobramycin-treated patients.

**Table 6**. Ocular related, treatment-emergent adverse events

+---------------------------------+---------------------+--------------+
|                                 | **Azithromycin**    | **           |
|                                 |                     | Tobramycin** |
|                                 | **(n=365)**         |              |
|                                 |                     | **(n=378)**  |
+---------------------------------+---------------------+--------------+
| Eye Irritation                  | 7 (1.9%)            | 4 (1.1%)     |
+---------------------------------+---------------------+--------------+
| Conjunctival hyperemia          | 4 (1.1%)            | 4 (1.1%)     |
+---------------------------------+---------------------+--------------+
| Worsening bacterial             | 4 (1.1%)            | 8 (2.1%)     |
| conjunctivitis                  |                     |              |
+---------------------------------+---------------------+--------------+

# 

# 

# 

# 

# 

# 

# *Azithromycin Ophthalmic Solution vs. Vehicle for Bacterial Conjunctivitis^6-7^*

The safety of azithromycin and vehicle was assessed in 683 patients (all
randomized patients). Overall, 12.3% of the patients in azithromycin arm
reported adverse events compared to 12.0% in vehicle arm. Most
frequently reported adverse events for azithromycin and vehicle arms
included eye irritation (1.5% vs 0.3%), worsening bacterial
conjunctivitis (1.5% vs. 0.9%), headache (1.2% vs 2.3%),
pharyngolaryngeal pain (1.2% vs 0.6%), and conjunctival edema (0.6% vs
1.4%). Worsening of visual acuity (defined as 3 lines or more on Snellen
chart) occurred in 1 (0.3%) patient in azithromycin arm and 3 (1.1%)
subjects in vehicle arm.

**[Contraindications/precautions]{.underline}**^1^

## Contraindications

-   None

**Warnings and Precautions**

-   This product should only be administered for topical ophthalmic use.

-   Anaphylaxis and hypersensitivity has been reported in patients who
    received systemically administered azithromycin. Thus, the potential
    for anaphylaxis and hypersensitivity should be considered for
    azithromycin ophthalmic solution.

-   Prolonged use of azithromycin ophthalmic solution may promote the
    growth of resistant organisms.

-   Avoid use of contact lenses in patients with bacterial
    conjunctivitis.

**Pregnancy/Nursing Mothers**

-   Pregnancy category B

-   It is not known if azithromycin is excreted in human breast milk.

# Look-alike / Sound-alike (LA / SA) Error Risk Potential

The VA PBM and Center for Medication Safety is conducting a pilot
program which queries a multi-attribute drug product search engine for
similar sounding and appearing drug names based on orthographic and
phonologic similarities, as well as similarities in dosage form,
strength and route of administration. Based on similarity scores as well
as clinical judgment, the following drug names [may]{.underline} be
potential sources of drug name confusion:

# 

[LA/SA for AzaSite]{.underline}

Azacitidine powder for injection, azasan tablet, azelastine ophthalmic
solution, azatadine tablet, azopt ophthalmic suspension, altazine
ophthalmic solution, antazoline ophthalmic solution

[LA/SA for azithromycin ophthalmic solution]{.underline}

Azithromycin hydrogencitrate injectable injection, azithromycin tablets,
erythromycin ophthalmic ointment, apraclonidine hydrochloride 1%
ophthalmic solution, atropine sulfate 1% ophthalmic solution, cortomycin
1% ophthalmic suspension

# 

# Drug-Drug Interactions^1^

Drug-drug interactions have not been conducted with azithromycin
ophthalmic solution. Based upon estimated undetectable plasma
concentrations with FDA-approved dosage regimen, no drug-drug
interactions are anticipated.

**Acquisition Costs**

Table 7. Cost for ophthalmic solutions and ointments per bottle

+------------------+--------------------------------+------------------+
| **Drug**         | **Dose**                       | **Cost per       |
|                  |                                | Bottle (\$)**    |
+------------------+--------------------------------+------------------+
| Azithromycin 1%  | Instill 1 drop in the affected | \$37.72 (2.5mL)  |
| ophthalmic       | eye(s) twice daily, eight to   |                  |
| solution         | twelve hours apart for the     |                  |
|                  | first 2 days and then instill  |                  |
|                  | 1 drop in the affected eye(s)  |                  |
|                  | once daily for the next 5      |                  |
|                  | days.                          |                  |
+------------------+--------------------------------+------------------+
| Bacitracin       | Apply thin ribbon every 3 to 4 | \$2.21 (3.5gm)   |
| ophthalmic       | h for 7 to 10 days             |                  |
| ointment         |                                |                  |
+------------------+--------------------------------+------------------+
| Baci             | Apply to affected eye(s) every | \$1.77 (3.5gm)   |
| tracin/polymyxin | 3 to 4 h for 7 to 10 days      |                  |
| ophthalmic       |                                |                  |
| ointment         |                                |                  |
+------------------+--------------------------------+------------------+
| Baci             | Apply to affected eye(s) every | \$1.26 (3.5gm)   |
| tracin/neomycin/ | 3 to 4 h for 7 to 10 days      |                  |
|                  |                                |                  |
| polymyxin        |                                |                  |
| ophthalmic       |                                |                  |
| ointment         |                                |                  |
+------------------+--------------------------------+------------------+
| Ciprofloxacin    | Instill 1-2 drops into the     | \$3.43 (2.5mL)   |
| 0.3% ophthalmic  | conjunctival sac(s) every 2    |                  |
| solution         | hours while awake for 2 days   | \$4.38 (5mL)     |
|                  | and 1-2 drops every 4 hours    |                  |
|                  | while awake for the next 5     | \$7.05 (10mL)    |
|                  | days                           |                  |
+------------------+--------------------------------+------------------+
| Erythromycin     | Apply 1 cm ribbon up to 6      | \$0.86 (3.5gm)   |
| ophthalmic       | times daily (depending on      |                  |
| ointment         | severity of infection)         |                  |
+------------------+--------------------------------+------------------+
| Gentamicin       | Apply one-half inch ribbon 2   | \$5.81 (3.5gm)   |
| ophthalmic       | to 3 times a day               |                  |
| ointment         |                                |                  |
+------------------+--------------------------------+------------------+
| Gentamicin 0.3%  | Instill 1-2 drops in the       | \$0.79 (5mL)     |
| ophthalmic       | affected eye(s) every 4 hours  |                  |
| solution         |                                | \$1.99 (15mL)    |
+------------------+--------------------------------+------------------+
| Gram             | Instill one or two drops into  | \$12.30 (10mL)   |
| icidin/neomycin/ | the affected eye every 4 hours |                  |
|                  | for 7 to 10 days               |                  |
| polymyxin        |                                |                  |
| ophthalmic       |                                |                  |
| solution         |                                |                  |
+------------------+--------------------------------+------------------+
| Moxifloxacin     | Instill 1 drop in the affected | \$15.91 (3mL)    |
| 0.5% ophthalmic  | eye(s) three times daily for 7 |                  |
| solution         | days                           |                  |
+------------------+--------------------------------+------------------+
| Ofloxacin 0.3%   | 1 to 2 drops every 2 - 4 hours | \$1.32 (20       |
| ophthalmic       | for 2 days then 4 times daily  | single use)      |
| solution         | for a total of 7 to 10 days    |                  |
|                  |                                | \$1.12 (5mL)     |
|                  |                                |                  |
|                  |                                | \$2.15 (10mL)    |
+------------------+--------------------------------+------------------+
| Polymy           | Instill one drop in the        | \$0.01 (10mL)    |
| xin/trimethoprim | affected eye(s) every 3 hours  |                  |
| ophthalmic       | (maximum of 6 doses per day)   | \$1.04 (10mL)    |
| solution         | for a period of 7 to 10 days   |                  |
|                  |                                | (different       |
|                  |                                | companies)       |
+------------------+--------------------------------+------------------+
| Sulfacetamide    | Apply one-half inch ribbon     | \$1.80 (3.5gm)   |
| ophthalmic       | into conjunctival sacs(s) of   |                  |
| ointment         | affected eye(s) every 3-4 hr   |                  |
|                  | and at bedtime; taper by       |                  |
|                  | increasing time intervals as   |                  |
|                  | condition respond for a total  |                  |
|                  | of 7-10 days                   |                  |
+------------------+--------------------------------+------------------+
| Sulfacetamide    | Instill 1 drop into the        | \$0.95 (10mL)    |
| 10% ophthalmic   | affected eye(s) every 1-3      |                  |
| solution         | hours while awake for 10 days  |                  |
+------------------+--------------------------------+------------------+
| Tobramycin 0.3%  | Instill 1-2 drops in the       | \$0.77 (5mL)     |
| ophthalmic       | affected eye(s) every 4 hours  |                  |
| solution         |                                |                  |
+------------------+--------------------------------+------------------+

# 

# 

# 

# 

# 

# Conclusions

Patients with bacterial conjunctivitis experienced similar rates of
successful clinical resolution and bacterial eradication when treated
with azithromycin ophthalmic 1% solution compared to tobramycin
ophthalmic. Azithromycin ophthalmic solution is well-tolerated in
patients with bacterial conjunctivitis.

**[Recommendations]{.underline}**

# Azithromycin 1% ophthalmic solution is an alternative to other ophthalmic preparations for the treatment of bacterial conjunctivitis. While azithromycin 1% ophthalmic solution is more expensive that other commonly utilized agents, it offers a less frequent dosing schedule. The differential impact that this may have on outcomes is unclear due to lack of adherence studies on the various preparations and their respective dosing regimens. 

# 

# References:

1\. Azasite^TM^ (Azithromycin Ophthalmic Solution) package insert,
Inspire Pharmaceuticals. May 2007.

2\. [Ohnsman
C](http://www.ncbi.nlm.nih.gov.ezproxyhost.library.tmc.edu/sites/entrez?Db=pubmed&Cmd=Search&Term="Ohnsman C"%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVAbstractPlus),
[Ritterband
D](http://www.ncbi.nlm.nih.gov.ezproxyhost.library.tmc.edu/sites/entrez?Db=pubmed&Cmd=Search&Term="Ritterband D"%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVAbstractPlus),
[O Brien
T](http://www.ncbi.nlm.nih.gov.ezproxyhost.library.tmc.edu/sites/entrez?Db=pubmed&Cmd=Search&Term="O Brien T"%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVAbstractPlus),
[Girgis
D](http://www.ncbi.nlm.nih.gov.ezproxyhost.library.tmc.edu/sites/entrez?Db=pubmed&Cmd=Search&Term="Girgis D"%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVAbstractPlus),
[Kabat
A](http://www.ncbi.nlm.nih.gov.ezproxyhost.library.tmc.edu/sites/entrez?Db=pubmed&Cmd=Search&Term="Kabat A"%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVAbstractPlus).
Comparison of azithromycin and moxifloxacin against bacterial
conjunctivitis isolates causing conjunctivitis. [Curr Med Res
Opin.](javascript:AL_get(this, 'jour', 'Curr Med Res Opin.');) 2007 Aug
8; \[Epub ahead of print\].

3\. Abelson MB, Shapiro AM, Heller W, The AzaSite Clinical Study Group.
A randomized trial assessing microbial eradication and clinical efficacy
of Azasite (1.0% azithromycin ophthalmic solution) vs tobramycin in
pediatric and adult subjects with bacterial conjunctivitis. Poster
presentation (#3589). The Association for Research in Vision and
Ophthalmology, May 3, 2006.

4.  Protzko E, Bowman L, Abelson M, Shapiro A. Phase 3 safety
    comparisons for 1.0% azithromycin in polymeric mucoadhesive eye
    drops versus 0.3% tobramycin eye drops for bacterial conjunctivitis.
    Invest Ophthalmol Vis Sci 2007;48:3425-3429.

5\. Protzko EE, Abelson MB, Shapiro AM. A randomized trial assessing the
safety and tolerability of 1.0% azithromycin ophthalmic solution vs
tobramycin in pediatric and adult subjects with bacterial
conjunctivitis. Poster presentation (#4958). The Association for
Research in Vision and Ophthalmology, May 4, 2006.

6.  Abelson MB, Shapiro AM, Heller W, The AzaSite Clinical Study Group.
    Efficacy of azithromycin 1% eye drops vs vehicle as first-line
    therapy for bacterial conjunctivitis. Poster presentation (#74).
    American Academy of Ophthalmology, November 11 -- 14, 2006.

7\. Heller W, Abelson MB, Shapiro AM, The AzaSite Clinical Study Group.
Safety and tolerability of azithromycin 1% eye drops as anti-infective
therapy for bacterial conjunctivitis. Poster presentation (#77).
American Academy of Opthalmology, November 11 -- 14, 2006.

Prepared 11/07 Contact person: Melinda Neuhauser, PharmD