Status:
COMPLETED
Study to Assess the Safety and Efficacy of BOL-303242-X Ophthalmic Suspension in Dry Eye Syndrome
Lead Sponsor:
Bausch & Lomb Incorporated
Conditions:
Dry Eye Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The objective of this study is to identify the concentration and daily dosing frequency of BOL-303242-X ophthalmic suspension in treating dry eye syndrome over a 12 week dosing period.
Eligibility Criteria
Inclusion
- Subjects who have a diagnosis of dry eye disease.
- Intraocular pressure (IOP) ≤28 mmHg with no IOP lowering medications.
- Subjects who are willing and able to refrain from using contact lenses during the study.
Exclusion
- Subjects with known hypersensitivity or contraindication to any component of the study medication.
- Subjects who are expected to require concurrent treatment with ophthalmic medications (prescription or over the counter).
- Subjects who are expected to require treatment with corticosteroids during the study.
- Subjects who have used topical or systemic isotretinoin, cyclosporine, or retinoid therapies within 30 days prior to the screening visit.
- Subjects who have undergone any type of ocular surgery within three months prior to screening.
- Lacrimal punctal occlusion (plugs or cautery) within 2 months of Screening Visit.
- Subjects with a history or presence of chronic generalized systemic or ocular disease that the Investigator feels might increase the risk to the subject or confound the result of the study.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
356 Patients enrolled
Trial Details
Trial ID
NCT01163643
Start Date
July 1 2010
End Date
July 1 2011
Last Update
September 25 2020
Active Locations (1)
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1
Bausch & Lomb
Rochester, New York, United States, 14609