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

Primary Purpose

Dry Eye Syndrome

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
0.3% BOL-303242-X ophthalmic suspension
2% BOL-303242-X ophthalmic suspension
Placebo Comparator: Vehicle
1% BOL-303242-X ophthalmic suspension
2% BOL-303242-X ophthalmic suspension AM
2% BOL-303242-X ophthalmic suspension PM
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Bausch & Lomb

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

0.3% BOL-303242-X ophthalmic suspension

2% BOL-303242-X ophthalmic suspension

Vehicle

1% BOL-303242-X ophthalmic suspension

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

2% BOL-303242-X ophthalmic suspension PM

Arm Description

0.3% BOL-303242-X ophthalmic suspension

2% BOL-303242-X ophthalmic suspension

Vehicle twice daily (BID)

1% BOL-303242-X ophthalmic suspension

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
July 9, 2010
Last Updated
September 2, 2020
Sponsor
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT01163643
Brief Title
Study to Assess the Safety and Efficacy of BOL-303242-X Ophthalmic Suspension in Dry Eye Syndrome
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
356 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.3% BOL-303242-X ophthalmic suspension
Arm Type
Experimental
Arm Description
0.3% BOL-303242-X ophthalmic suspension
Arm Title
2% BOL-303242-X ophthalmic suspension
Arm Type
Experimental
Arm Description
2% BOL-303242-X ophthalmic suspension
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Vehicle twice daily (BID)
Arm Title
1% BOL-303242-X ophthalmic suspension
Arm Type
Experimental
Arm Description
1% BOL-303242-X ophthalmic suspension
Arm Title
2% BOL-303242-X ophthalmic suspension in the morning
Arm Type
Experimental
Arm Description
2% BOL-303242-X ophthalmic suspension in the morning (AM) and vehicle in the afternoon (PM)
Arm Title
2% BOL-303242-X ophthalmic suspension PM
Arm Type
Experimental
Arm Description
Vehicle in the AM and 2% BOL-303242-X ophthalmic suspension in the PM.
Intervention Type
Drug
Intervention Name(s)
0.3% BOL-303242-X ophthalmic suspension
Intervention Description
0.3% BOL-303242-X ophthalmic suspension BID for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
2% BOL-303242-X ophthalmic suspension
Intervention Description
2% BOL-303242-X ophthalmic suspension BID for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo Comparator: Vehicle
Intervention Description
Placebo Comparator: Vehicle BID for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
1% BOL-303242-X ophthalmic suspension
Intervention Description
1% BOL-303242-X ophthalmic suspension BID for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
2% BOL-303242-X ophthalmic suspension AM
Intervention Description
2% BOL-303242-X ophthalmic suspension once daily (QD) AM and vehicle QD in PM for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
2% BOL-303242-X ophthalmic suspension PM
Intervention Description
Vehicle QD AM and 2% BOL-303242-X ophthalmic suspension QD in PM for 12 weeks.
Primary Outcome Measure Information:
Title
Mean Corneal Staining Score
Description
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.
Time Frame
12 weeks
Title
Mean Worst Visual Analog Scale(VAS) Dry Eye Symptom
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tuyen Ong, MD
Organizational Affiliation
Bausch & Lomb Incorporated
Official's Role
Study Director
Facility Information:
Facility Name
Bausch & Lomb
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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