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

Phase 2

Completed

• Conditions: Dry Eye Syndrome
• Interventions: Drug: 2% BOL-303242-X ophthalmic suspension; Drug: 0.3% BOL-303242-X ophthalmic suspension; Drug: 1% BOL-303242-X ophthalmic suspension; Drug: 2% BOL-303242-X ophthalmic suspension AM; Drug: 2% BOL-303242-X ophthalmic suspension PM

• Registration Number: NCT01163643
• Lead Sponsor: Bausch & Lomb Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-09
• Study First Submitted QC: 2010-07-15
• Study First Posted: 2010-07-16
• Primary Completion: 2011-06
• Study Completion: 2011-07
• Disposition First Submitted: 2012-03-27
• Disposition First Submitted QC: 2012-05-03
• Disposition First Posted: 2012-05-07
• Results First Submitted: 2020-08-18
• Results First Submitted QC: 2020-08-18
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-02
• Results First Posted: 2020-09-03
• Last Update Posted: 2020-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 356

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2% BOL-303242-X ophthalmic suspension	2% BOL-303242-X ophthalmic suspension	2% BOL-303242-X ophthalmic suspension
0.3% BOL-303242-X ophthalmic suspension	0.3% BOL-303242-X ophthalmic suspension	0.3% BOL-303242-X ophthalmic suspension
1% BOL-303242-X ophthalmic suspension	1% BOL-303242-X ophthalmic suspension	1% BOL-303242-X ophthalmic suspension
2% BOL-303242-X ophthalmic suspension in the morning	2% BOL-303242-X ophthalmic suspension AM	2% BOL-303242-X ophthalmic suspension in the morning (AM) and vehicle in the afternoon (PM)
2% BOL-303242-X ophthalmic suspension PM	2% BOL-303242-X ophthalmic suspension PM	Vehicle in the AM and 2% BOL-303242-X ophthalmic suspension in the PM.

Primary Outcome Measures

Name	Time	Method
Mean Worst Visual Analog Scale(VAS) Dry Eye Symptom	12 weeks	Each symptom (ocular discomfort, dryness, grittiness, and stinging) was assessed to the nearest millimeter on a 0 - 10 cm Visual Analog Scale (VAS) by the subject. The worst VAS dry eye symptom was utilized in the analysis. The minimum for the worst symptom was 0 and the maximum for the worst symptom was 10.
Mean Corneal Staining Score	12 weeks	Total corneal staining score was calculated by adding the individual grades from 5 regions of the corneal surface (1: Central; 2: Superior; 3: Temporal; 4: Nasal; 5: Inferior). Grade 0 = none and Grade 3 = severe. The minimum total score possible was 0 and the maximum total score possible was 15. Higher scores indicated worse outcome.

Trial Locations

Locations (1)

Bausch & Lomb; 🇺🇸 Rochester, New York, United States