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

Dry Eye Syndrome Clinical Trial

Official title:

A Randomized, Double-Masked, Parallel-Group, Vehicle Controlled, Multicenter, Exploratory Study Assessing the Safety and Efficacy of BOL-303242-X Ophthalmic Suspension in Dry Eye Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01163643
• Other study ID #: 637
• Status: Completed
• Phase: Phase 2
• Start date: July 2010
• Est. completion date: July 2011

Study information

• Verified date: September 2020
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 356
• Est. completion date: July 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Syndrome

Intervention

Drug:
• 0.3% BOL-303242-X ophthalmic suspension
0.3% BOL-303242-X ophthalmic suspension BID for 12 weeks.
• 2% BOL-303242-X ophthalmic suspension
2% BOL-303242-X ophthalmic suspension BID for 12 weeks.
• Placebo Comparator: Vehicle
Placebo Comparator: Vehicle BID for 12 weeks.
• 1% BOL-303242-X ophthalmic suspension
1% BOL-303242-X ophthalmic suspension BID for 12 weeks.
• 2% BOL-303242-X ophthalmic suspension AM
2% BOL-303242-X ophthalmic suspension once daily (QD) AM and vehicle QD in PM for 12 weeks.
• 2% BOL-303242-X ophthalmic suspension PM
Vehicle QD AM and 2% BOL-303242-X ophthalmic suspension QD in PM for 12 weeks.

Locations

Country	Name	City	State
United States	Bausch & Lomb	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Corneal Staining Score	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.	12 weeks
Primary	Mean Worst Visual Analog Scale(VAS) Dry Eye Symptom	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.	12 weeks