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

Bausch + Lomb

Status and phase: Completed; Phase 2

Conditions: Dry Eye Syndrome

Treatments: Drug: 2% BOL-303242-X ophthalmic suspension PM; Drug: 1% BOL-303242-X ophthalmic suspension; Drug: 2% BOL-303242-X ophthalmic suspension; Drug: 0.3% BOL-303242-X ophthalmic suspension; Drug: Placebo Comparator: Vehicle; Drug: 2% BOL-303242-X ophthalmic suspension AM

Study type: Interventional

Funder types: Industry

Identifiers

NCT01163643

637

Details and patient eligibility

About

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.

Enrollment: 356 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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356 participants in 6 patient groups, including a placebo group

0.3% BOL-303242-X ophthalmic suspension

Experimental group

Description:

0.3% BOL-303242-X ophthalmic suspension

Treatment:

Drug: 0.3% BOL-303242-X ophthalmic suspension

2% BOL-303242-X ophthalmic suspension

Experimental group

Description:

2% BOL-303242-X ophthalmic suspension

Treatment:

Drug: 2% BOL-303242-X ophthalmic suspension

Vehicle

Placebo Comparator group

Description:

Vehicle twice daily (BID)

Treatment:

Drug: Placebo Comparator: Vehicle

1% BOL-303242-X ophthalmic suspension

Experimental group

Description:

1% BOL-303242-X ophthalmic suspension

Treatment:

Drug: 1% BOL-303242-X ophthalmic suspension

2% BOL-303242-X ophthalmic suspension in the morning

Experimental group

Description:

2% BOL-303242-X ophthalmic suspension in the morning (AM) and vehicle in the afternoon (PM)

Treatment:

Drug: 2% BOL-303242-X ophthalmic suspension AM

2% BOL-303242-X ophthalmic suspension PM

Experimental group

Description:

Vehicle in the AM and 2% BOL-303242-X ophthalmic suspension in the PM.

Treatment:

Drug: 2% BOL-303242-X ophthalmic suspension PM