- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01163643
Study to Assess the Safety and Efficacy of BOL-303242-X Ophthalmic Suspension in Dry Eye Syndrome
September 2, 2020 updated by: Bausch & Lomb Incorporated
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
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
356
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Rochester, New York, United States, 14609
- Bausch & Lomb
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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 BID for 12 weeks.
|
PLACEBO_COMPARATOR: Vehicle
Vehicle twice daily (BID)
|
Placebo Comparator: Vehicle BID for 12 weeks.
|
EXPERIMENTAL: 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)
|
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.
|
Vehicle QD AM and 2% BOL-303242-X ophthalmic suspension QD in PM for 12 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Corneal Staining Score
Time Frame: 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.
|
12 weeks
|
Mean Worst Visual Analog Scale(VAS) Dry Eye Symptom
Time Frame: 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.
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2010
Primary Completion (ACTUAL)
June 1, 2011
Study Completion (ACTUAL)
July 1, 2011
Study Registration Dates
First Submitted
July 9, 2010
First Submitted That Met QC Criteria
July 15, 2010
First Posted (ESTIMATE)
July 16, 2010
Study Record Updates
Last Update Posted (ACTUAL)
September 25, 2020
Last Update Submitted That Met QC Criteria
September 2, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 637
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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