Effects Of Ciclesonide And Beclomethasone On Lens Opacification In Adult Subjects With Moderate To Severe Persistent Asthma

Inclusion Criteria:

• Males or non-pregnant, non-lactating females 18 years of age and older with a historyof moderate to severe persistent asthma for a duration of at least 2 months prior toscreening.

• At screening, FEV1 must be ≥ 40% and ≤ 85% of predicted.

• Documented use of inhaled corticosteroid therapy at any dose for at least 1 monthprior to screening.

• Able to demonstrate acceptable oral inhaler technique.

• Non-smoker for at least the past year and less than a 10 pack-year smoking history ifprevious smoker.

• Written informed consent agreement.

Exclusion Criteria:

• History of prior cataract surgery in either eye.

• Evidence of congenital cortical cataract.

• Inability to grade nuclear, cortical, or posterior subcapsular opacities in either eyewith LOCS III at the baseline slit lamp examination.

• Inability to dilate pupils to at least 6.0 mm.

• Nuclear opalescence with a LOCS III grade ≥ 4 in either eye at the baseline slit lampexamination.

• Cortical lens opacities with a LOCS III grade ≥ 3 in either eye at the baseline slitlamp examination.

• Posterior subcapsular lens opacities with a LOCS III grade ≥ 2 in either eye at thebaseline slit lamp examination.

• Elevated intraocular pressure requiring treatment

• Best corrected visual acuity less than 74 letters (equivalent to vision worse than 20/30) in either eye at baseline.

• Females who are pregnant or lactating or have a positive pregnancy test at Visit 1 (Screening).

• Have had more than 1 in-patient hospitalization in the past year for asthmaexacerbations.

• Have had more than 2 bursts of oral steroids per year for each of the past 2 yearsprior to screening.

• Chronic use of oral, injectable, or topical steroids except for inhaledcorticosteroids for any condition. Topical corticosteroids designated as having a mildpotency by the Stoughton-Cornell Scale or the European Guideline for levels ofcorticosteroid activity are allowed (see AppendixG).

• Any chronic condition that is likely to require treatment with oral or systemiccorticosteroids other than asthma (e.g. systemic lupus, inflammatory bowel disease,rheumatoid arthritis).

• Topical ocular steroid treatment within 3 months prior to screening.

• Chronic or recurrent inflammatory disease in either eye likely to result in visualabnormalities or require treatment with ocular steroids.

• History of drug or alcohol abuse.

• Any clinically significant medical condition that would interfere with the subject'sability to participate in and comply with study protocol.

• Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability toreturn for follow-up visits, and unlikelihood of completing the study.

• Subject is the investigator or any sub-investigator, research assistant, pharmacist,study coordinator, other staff or relative thereof directly involved in the conduct ofthe protocol.

• Hypersensitivity to the investigational products or to drugs with similar chemicalstructures.

• Have been treated with any investigational drug/product within 30 days prior to Visit 1 (Screening).