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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01163643
First received: July 9, 2010
Last updated: May 30, 2013
Last verified: May 2013
History of Changes

July 9, 2010
May 30, 2013
July 2010
June 2011   (final data collection date for primary outcome measure)
Ocular Adverse Events(AE's) [ Time Frame: Visit 7; 12 weeks ] [ Designated as safety issue: No ]
Treatment emergent ocular AE's
Same as current
Complete list of historical versions of study NCT01163643 on ClinicalTrials.gov Archive Site
  • Corneal Staining Score [ Time Frame: Each visit and change from baseline to each visit, over 12 weeks ] [ Designated as safety issue: No ]
    Total corneal staining score
  • Worst visual analog scale(VAS) dry eye symptom [ Time Frame: Each visit and change from baseline to each visit, over 12 weeks ] [ Designated as safety issue: No ]
    Worst VAS dry eye symptom
Same as current
Not Provided
Not Provided
 
Study to Assess the Safety and Efficacy of BOL-303242-X Ophthalmic Suspension in Dry Eye Syndrome
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Dry Eye Syndrome
  • Drug: 0.3% BOL-303242-X ophthalmic suspension
    0.3% BOL-303242-X ophthalmic suspension BID for 12 weeks.
  • Drug: 2% BOL-303242-X ophthalmic suspension
    2% BOL-303242-X ophthalmic suspension BID for 12 weeks.
  • Drug: Placebo Comparator: Vehicle
    Placebo Comparator: Vehicle BID for 12 weeks.
  • Drug: 1% BOL-303242-X ophthalmic suspension
    1% BOL-303242-X ophthalmic suspension BID for 12 weeks.
  • 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.
  • Drug: 2% BOL-303242-X ophthalmic suspension PM
    Vehicle QD AM and 2% BOL-303242-X ophthalmic suspension QD in PM for 12 weeks.
  • Experimental: 0.3% BOL-303242-X ophthalmic suspension
    0.3% BOL-303242-X ophthalmic suspension
    Intervention: Drug: 0.3% BOL-303242-X ophthalmic suspension
  • Experimental: 2% BOL-303242-X ophthalmic suspension
    2% BOL-303242-X ophthalmic suspension
    Intervention: Drug: 2% BOL-303242-X ophthalmic suspension
  • Placebo Comparator: Vehicle
    Vehicle twice daily (BID)
    Intervention: Drug: Placebo Comparator: Vehicle
  • Experimental: 1% BOL-303242-X ophthalmic suspension
    1% BOL-303242-X ophthalmic suspension
    Intervention: Drug: 1% BOL-303242-X ophthalmic suspension
  • 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)
    Intervention: Drug: 2% BOL-303242-X ophthalmic suspension AM
  • Experimental: 2% BOL-303242-X ophthalmic suspension PM
    Vehicle in the AM and 2% BOL-303242-X ophthalmic suspension in the PM.
    Intervention: Drug: 2% BOL-303242-X ophthalmic suspension PM
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
350
July 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01163643
637
No
Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
Not Provided
Study Director: Tuyen Ong, MD Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP