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Sponsored by: |
Alcon Research |
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Information provided by: | Alcon Research |
ClinicalTrials.gov Identifier: | NCT00890097 |
Randomized, multi-center, placebo-controlled study evaluating AL-8309B as a topical ocular treatment for geographic atrophy secondary to AMD
Condition | Intervention | Phase |
---|---|---|
Geographic Atrophy Age Related Macular Degeneration |
Drug: 1.75% AL-8309B Ophthalmic Solution Drug: 1.0% AL-8309B Ophthalmic Solution Drug: AL-8309B Ophthalmic Solution Vehicle |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment |
Estimated Enrollment: | 550 |
Study Start Date: | April 2009 |
Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
1.75% AL-8309B Ophthalmic Solution
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Drug: 1.75% AL-8309B Ophthalmic Solution
One drop 2x daily
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2: Experimental
1.0% AL-8309B Ophthalmic Solution
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Drug: 1.0% AL-8309B Ophthalmic Solution
One drop 2x daily
|
3: Placebo Comparator
AL-8309B Ophthalmic Solution Vehicle
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Drug: AL-8309B Ophthalmic Solution Vehicle
One drop 2x daily
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Ages Eligible for Study: | 55 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The study eye must have:
Exclusion Criteria:
Contact: Alcon Call Center | 1-888-451-3937 | medical.information@alconlabs.com |
United States, Texas | |
Alcon Call Center for Trial Locations | Recruiting |
Fort Worth, Texas, United States, 76134 | |
Contact: Guy Simpson, Pharm. D. 817-615-2293 guy.simpson@alconlabs.com |
Responsible Party: | Alcon Research ( Guy Simpson\Asst. Director, Clinical Trial Management ) |
Study ID Numbers: | C-08-36 |
Study First Received: | April 27, 2009 |
Last Updated: | April 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00890097 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Geographic Atrophy AMD age related macular degeneration Geographic Atrophy Secondary amd |
Pathological Conditions, Anatomical Eye Diseases Neoplasm Metastasis Retinal Degeneration |
Macular Degeneration Atrophy Retinal Diseases |
Pathological Conditions, Anatomical Eye Diseases Retinal Degeneration |
Macular Degeneration Atrophy Retinal Diseases |