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

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 eye with 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 lamp examination.
• •Cortical lens opacities with a LOCS III grade ≥ 3 in either eye at the baseline slit lamp examination.
• •Posterior subcapsular lens opacities with a LOCS III grade ≥ 2 in either eye at the baseline 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 asthma exacerbations.
• •Have had more than 2 bursts of oral steroids per year for each of the past 2 years prior to screening.
• •Chronic use of oral, injectable, or topical steroids except for inhaled corticosteroids for any condition. Topical corticosteroids designated as having a mild potency by the Stoughton-Cornell Scale or the European Guideline for levels of corticosteroid activity are allowed (see AppendixG).
• •Any chronic condition that is likely to require treatment with oral or systemic corticosteroids 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 visual abnormalities or require treatment with ocular steroids.
• •History of drug or alcohol abuse.
• •Any clinically significant medical condition that would interfere with the subject's ability to participate in and comply with study protocol.
• •Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return 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 of the protocol.
• •Hypersensitivity to the investigational products or to drugs with similar chemical structures.
• •Have been treated with any investigational drug/product within 30 days prior to Visit 1 (Screening).