Study to Assess the Safety and Efficacy of BOL-303242-X Ophthalmic Suspension in Dry Eye Syndrome

Completed · Phase 2 · Has a placebo group

Conditions studied: Dry Eye Syndrome

In brief

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.

Key facts

Study ID

NCT01163643

Run by

Bausch & Lomb Incorporated

People needed

356

Starts

2010-07-01

Expected to finish

2011-07-01

Last updated by the study team

2020-09-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Bausch & Lomb — Rochester, New York, United States

Full record on ClinicalTrials.gov

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