Study to Assess the Safety and Efficacy of BOL-303242-X Ophthalmic Suspension in Dry Eye Syndrome
Sponsor
Bausch & Lomb Incorporated (Industry)
Overall Status
Completed
CT.gov ID
NCT01163643
Collaborator
(none)
356
1
6
12
29.7
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
356 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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 Start Date
:
Jul 1, 2010
Actual Primary Completion Date
:
Jun 1, 2011
Actual Study Completion Date
:
Jul 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 0.3% BOL-303242-X ophthalmic suspension 0.3% BOL-303242-X ophthalmic suspension |
Drug: 0.3% BOL-303242-X ophthalmic suspension
0.3% BOL-303242-X ophthalmic suspension BID for 12 weeks.
|
| Experimental: 2% BOL-303242-X ophthalmic suspension 2% BOL-303242-X ophthalmic suspension |
Drug: 2% BOL-303242-X ophthalmic suspension
2% BOL-303242-X ophthalmic suspension BID for 12 weeks.
|
| Placebo Comparator: Vehicle Vehicle twice daily (BID) |
Drug: Placebo Comparator: Vehicle
Placebo Comparator: Vehicle BID for 12 weeks.
|
| Experimental: 1% BOL-303242-X ophthalmic suspension 1% BOL-303242-X ophthalmic suspension |
Drug: 1% BOL-303242-X ophthalmic suspension
1% BOL-303242-X ophthalmic suspension BID for 12 weeks.
|
| Experimental: 2% BOL-303242-X ophthalmic suspension in the morning 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 once daily (QD) AM and vehicle QD in PM for 12 weeks.
|
| Experimental: 2% BOL-303242-X ophthalmic suspension PM Vehicle in the AM and 2% BOL-303242-X ophthalmic suspension in the PM. |
Drug: 2% BOL-303242-X ophthalmic suspension PM
Vehicle QD AM and 2% BOL-303242-X ophthalmic suspension QD in PM for 12 weeks.
|
Outcome Measures
Primary Outcome Measures
- 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.
- 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bausch & Lomb | Rochester | New York | United States | 14609 |
Sponsors and Collaborators
- Bausch & Lomb Incorporated
Investigators
- Study Director: Tuyen Ong, MD, Bausch & Lomb Incorporated
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01163643
Other Study ID Numbers:
- 637
First Posted:
Jul 16, 2010
Last Update Posted:
Sep 25, 2020
Last Verified:
Sep 1, 2020
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | 2% BOL-303242-X Ophthalmic Suspension | 2% BOL-303242-X Ophthalmic Suspension in the Morning | 2% BOL-303242-X Ophthalmic Suspension PM | 1% BOL-303242-X Ophthalmic Suspension | 0.3% BOL-303242-X Ophthalmic Suspension | Vehicle |
|---|---|---|---|---|---|---|
| Arm/Group Description | 2% BOL-303242-X ophthalmic suspension 2% BOL-303242-X ophthalmic suspension: 2% BOL-303242-X ophthalmic suspension BID for 12 weeks. | 2% BOL-303242-X ophthalmic suspension in the morning (AM) and vehicle in the afternoon (PM) 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. | Vehicle in the AM and 2% BOL-303242-X ophthalmic suspension in the PM. 2% BOL-303242-X ophthalmic suspension PM: Vehicle QD AM and 2% BOL-303242-X ophthalmic suspension QD in PM for 12 weeks. | 1% BOL-303242-X ophthalmic suspension 1% BOL-303242-X ophthalmic suspension: 1% BOL-303242-X ophthalmic suspension BID for 12 weeks. | 0.3% BOL-303242-X ophthalmic suspension 0.3% BOL-303242-X ophthalmic suspension: 0.3% BOL-303242-X ophthalmic suspension BID for 12 weeks. | Vehicle twice daily (BID) Placebo Comparator: Vehicle: Placebo Comparator: Vehicle BID for 12 weeks. |
| Period Title: Overall Study | ||||||
| STARTED | 68 | 37 | 35 | 74 | 69 | 73 |
| COMPLETED | 62 | 35 | 33 | 69 | 61 | 66 |
| NOT COMPLETED | 6 | 2 | 2 | 5 | 8 | 7 |
Baseline Characteristics
| Arm/Group Title | 2% BOL-303242-X Ophthalmic Suspension | 2% BOL-303242-X Ophthalmic Suspension in the Morning | 2% BOL-303242-X Ophthalmic Suspension PM | 1% BOL-303242-X Ophthalmic Suspension | 0.3% BOL-303242-X Ophthalmic Suspension | Vehicle | Total |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | 2% BOL-303242-X ophthalmic suspension 2% BOL-303242-X ophthalmic suspension: 2% BOL-303242-X ophthalmic suspension BID for 12 weeks. | 2% BOL-303242-X ophthalmic suspension in the morning (AM) and vehicle in the afternoon (PM) 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. | Vehicle in the AM and 2% BOL-303242-X ophthalmic suspension in the PM. 2% BOL-303242-X ophthalmic suspension PM: Vehicle QD AM and 2% BOL-303242-X ophthalmic suspension QD in PM for 12 weeks. | 1% BOL-303242-X ophthalmic suspension 1% BOL-303242-X ophthalmic suspension: 1% BOL-303242-X ophthalmic suspension BID for 12 weeks. | 0.3% BOL-303242-X ophthalmic suspension 0.3% BOL-303242-X ophthalmic suspension: 0.3% BOL-303242-X ophthalmic suspension BID for 12 weeks. | Vehicle twice daily (BID) Placebo Comparator: Vehicle: Placebo Comparator: Vehicle BID for 12 weeks. | Total of all reporting groups |
| Overall Participants | 68 | 37 | 35 | 74 | 69 | 73 | 356 |
| Age (years) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [years] |
48.6
(17.79)
|
50.6
(16.99)
|
51.8
(18.10)
|
46.3
(17.64)
|
46.5
(15.91)
|
49.5
(17.56)
|
48.4
(17.29)
|
| Sex: Female, Male (Count of Participants) | |||||||
| Female |
45
66.2%
|
26
70.3%
|
24
68.6%
|
49
66.2%
|
48
69.6%
|
50
68.5%
|
242
68%
|
| Male |
23
33.8%
|
11
29.7%
|
11
31.4%
|
25
33.8%
|
21
30.4%
|
23
31.5%
|
114
32%
|
Outcome Measures
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Randomized participants with Week 12 results were included, with no imputation of missing data at Week 12. |
| Arm/Group Title | 2% BOL-303242-X Ophthalmic Suspension | 2% BOL-303242-X Ophthalmic Suspension in the Morning | 2% BOL-303242-X Ophthalmic Suspension PM | 1% BOL-303242-X Ophthalmic Suspension | 0.3% BOL-303242-X Ophthalmic Suspension | Vehicle |
|---|---|---|---|---|---|---|
| Arm/Group Description | 2% BOL-303242-X ophthalmic suspension 2% BOL-303242-X ophthalmic suspension: 2% BOL-303242-X ophthalmic suspension BID for 12 weeks. | 2% BOL-303242-X ophthalmic suspension in the morning (AM) and vehicle in the afternoon (PM) 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. | Vehicle in the AM and 2% BOL-303242-X ophthalmic suspension in the PM. 2% BOL-303242-X ophthalmic suspension PM: Vehicle QD AM and 2% BOL-303242-X ophthalmic suspension QD in PM for 12 weeks. | 1% BOL-303242-X ophthalmic suspension 1% BOL-303242-X ophthalmic suspension: 1% BOL-303242-X ophthalmic suspension BID for 12 weeks. | 0.3% BOL-303242-X ophthalmic suspension 0.3% BOL-303242-X ophthalmic suspension: 0.3% BOL-303242-X ophthalmic suspension BID for 12 weeks. | Vehicle twice daily (BID) Placebo Comparator: Vehicle: Placebo Comparator: Vehicle BID for 12 weeks. |
| Measure Participants | 64 | 35 | 33 | 71 | 64 | 67 |
| Mean (Standard Deviation) [score on a scale] |
4.0
(3.19)
|
3.9
(3.87)
|
3.9
(3.66)
|
4.4
(3.53)
|
4.1
(3.03)
|
3.7
(3.33)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Randomized participants with Week 12 results were included, with no imputation of missing data at Week 12. |
| Arm/Group Title | 2% BOL-303242-X Ophthalmic Suspension | 2% BOL-303242-X Ophthalmic Suspension in the Morning | 2% BOL-303242-X Ophthalmic Suspension PM | 1% BOL-303242-X Ophthalmic Suspension | 0.3% BOL-303242-X Ophthalmic Suspension | Vehicle |
|---|---|---|---|---|---|---|
| Arm/Group Description | 2% BOL-303242-X ophthalmic suspension 2% BOL-303242-X ophthalmic suspension: 2% BOL-303242-X ophthalmic suspension BID for 12 weeks. | 2% BOL-303242-X ophthalmic suspension in the morning (AM) and vehicle in the afternoon (PM) 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. | Vehicle in the AM and 2% BOL-303242-X ophthalmic suspension in the PM. 2% BOL-303242-X ophthalmic suspension PM: Vehicle QD AM and 2% BOL-303242-X ophthalmic suspension QD in PM for 12 weeks. | 1% BOL-303242-X ophthalmic suspension 1% BOL-303242-X ophthalmic suspension: 1% BOL-303242-X ophthalmic suspension BID for 12 weeks. | 0.3% BOL-303242-X ophthalmic suspension 0.3% BOL-303242-X ophthalmic suspension: 0.3% BOL-303242-X ophthalmic suspension BID for 12 weeks. | Vehicle twice daily (BID) Placebo Comparator: Vehicle: Placebo Comparator: Vehicle BID for 12 weeks. |
| Measure Participants | 64 | 34 | 33 | 71 | 65 | 67 |
| Mean (Standard Deviation) [score on a scale] |
2.256
(2.3172)
|
2.954
(2.4688)
|
2.290
(2.4885)
|
2.407
(2.6070)
|
2.535
(2.5565)
|
2.026
(2.1849)
|
Adverse Events
| Time Frame | 12 weeks | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | The safety population included participants who received at least 1 dose of study drug. Participants confirmed to have never took a dose of study drug were excluded from safety analyses. Of the randomized participants, there was one 2% BOL-303242-X Ophthalmic Suspension participant, one 2% BOL-303242-X Ophthalmic Suspension PM participant, one 1% BOL-303242-X Ophthalmic Suspension participant, and 2 Vehicle participants who did not take at least one dose of study drug. | |||||||||||
| Arm/Group Title | 2% BOL-303242-X Ophthalmic Suspension | 2% BOL-303242-X Ophthalmic Suspension in the Morning | 2% BOL-303242-X Ophthalmic Suspension PM | 1% BOL-303242-X Ophthalmic Suspension | 0.3% BOL-303242-X Ophthalmic Suspension | Vehicle | ||||||
| Arm/Group Description | 2% BOL-303242-X ophthalmic suspension 2% BOL-303242-X ophthalmic suspension: 2% BOL-303242-X ophthalmic suspension BID for 12 weeks. | 2% BOL-303242-X ophthalmic suspension in the morning (AM) and vehicle in the afternoon (PM) 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. | Vehicle in the AM and 2% BOL-303242-X ophthalmic suspension in the PM. 2% BOL-303242-X ophthalmic suspension PM: Vehicle QD AM and 2% BOL-303242-X ophthalmic suspension QD in PM for 12 weeks. | 1% BOL-303242-X ophthalmic suspension 1% BOL-303242-X ophthalmic suspension: 1% BOL-303242-X ophthalmic suspension BID for 12 weeks. | 0.3% BOL-303242-X ophthalmic suspension 0.3% BOL-303242-X ophthalmic suspension: 0.3% BOL-303242-X ophthalmic suspension BID for 12 weeks. | Vehicle twice daily (BID) Placebo Comparator: Vehicle: Placebo Comparator: Vehicle BID for 12 weeks. | ||||||
All Cause Mortality |
||||||||||||
| 2% BOL-303242-X Ophthalmic Suspension | 2% BOL-303242-X Ophthalmic Suspension in the Morning | 2% BOL-303242-X Ophthalmic Suspension PM | 1% BOL-303242-X Ophthalmic Suspension | 0.3% BOL-303242-X Ophthalmic Suspension | Vehicle | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||||
Serious Adverse Events |
||||||||||||
| 2% BOL-303242-X Ophthalmic Suspension | 2% BOL-303242-X Ophthalmic Suspension in the Morning | 2% BOL-303242-X Ophthalmic Suspension PM | 1% BOL-303242-X Ophthalmic Suspension | 0.3% BOL-303242-X Ophthalmic Suspension | Vehicle | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/67 (0%) | 0/37 (0%) | 0/34 (0%) | 0/73 (0%) | 0/69 (0%) | 0/71 (0%) | ||||||
Other (Not Including Serious) Adverse Events |
||||||||||||
| 2% BOL-303242-X Ophthalmic Suspension | 2% BOL-303242-X Ophthalmic Suspension in the Morning | 2% BOL-303242-X Ophthalmic Suspension PM | 1% BOL-303242-X Ophthalmic Suspension | 0.3% BOL-303242-X Ophthalmic Suspension | Vehicle | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/67 (1.5%) | 2/37 (5.4%) | 1/34 (2.9%) | 2/73 (2.7%) | 3/69 (4.3%) | 5/71 (7%) | ||||||
| Infections and infestations | ||||||||||||
| Urinary Tract Infection | 1/67 (1.5%) | 2/37 (5.4%) | 1/34 (2.9%) | 2/73 (2.7%) | 3/69 (4.3%) | 5/71 (7%) | ||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Contact sponsor directly for details.
Results Point of Contact
| Name/Title | Study Director |
|---|---|
| Organization | Bausch Health |
| Phone | |
| susan.harris@bauschhealth.com |
Responsible Party:
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01163643
Other Study ID Numbers:
- 637
First Posted:
Jul 16, 2010
Last Update Posted:
Sep 25, 2020
Last Verified:
Sep 1, 2020