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

NCT01163643 | Completed Phase 2 Results

• 1 other identifier: 637
• Study Type: interventional
• Target: 356
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye Syndrome

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (6)

0.3% BOL-303242-X ophthalmic suspension

EXPERIMENTAL

0.3% BOL-303242-X ophthalmic suspension

Drug: 0.3% BOL-303242-X ophthalmic suspension

2% BOL-303242-X ophthalmic suspension

EXPERIMENTAL

2% BOL-303242-X ophthalmic suspension

Drug: 2% BOL-303242-X ophthalmic suspension

Vehicle

PLACEBO COMPARATOR

Vehicle twice daily (BID)

Drug: Placebo Comparator: Vehicle

1% BOL-303242-X ophthalmic suspension

EXPERIMENTAL

1% BOL-303242-X ophthalmic suspension

Drug: 1% BOL-303242-X ophthalmic suspension

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

EXPERIMENTAL

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

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

2% BOL-303242-X ophthalmic suspension PM

EXPERIMENTAL

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

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

Interventions

0.3% BOL-303242-X ophthalmic suspension DRUG

0.3% BOL-303242-X ophthalmic suspension BID for 12 weeks.

0.3% BOL-303242-X ophthalmic suspension

2% BOL-303242-X ophthalmic suspension DRUG

2% BOL-303242-X ophthalmic suspension BID for 12 weeks.

2% BOL-303242-X ophthalmic suspension

Placebo Comparator: Vehicle DRUG

Placebo Comparator: Vehicle BID for 12 weeks.

Vehicle

1% BOL-303242-X ophthalmic suspension DRUG

1% BOL-303242-X ophthalmic suspension BID for 12 weeks.

1% BOL-303242-X ophthalmic suspension

2% BOL-303242-X ophthalmic suspension AM DRUG

2% BOL-303242-X ophthalmic suspension once daily (QD) AM and vehicle QD in PM for 12 weeks.

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

2% BOL-303242-X ophthalmic suspension PM DRUG

Vehicle QD AM and 2% BOL-303242-X ophthalmic suspension QD in PM for 12 weeks.

2% BOL-303242-X ophthalmic suspension PM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Bausch & Lomb

Rochester, New York, 14609, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Study Director
• Organization: Bausch Health

susan.harris@bauschhealth.com

Study Officials

• Tuyen Ong, MD

  Bausch & Lomb Incorporated

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2010
• First Posted: July 16, 2010
• Study Start: July 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: July 1, 2011
• Last Updated: September 25, 2020
• Results First Posted: September 3, 2020

Record last verified: 2020-09

Locations

US (1)