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: November 22, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Dry Eye Syndrome
Drug: 0.3% BOL-303242-X ophthalmic suspension
Drug: 2% BOL-303242-X ophthalmic suspension
Drug: Placebo Comparator: Vehicle
Drug: 1% BOL-303242-X ophthalmic suspension
Drug: 2% BOL-303242-X ophthalmic suspension AM
Drug: 2% BOL-303242-X ophthalmic suspension PM
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Ocular Adverse Events(AE's) [ Time Frame: Visit 7; 12 weeks ] [ Designated as safety issue: No ]
    Treatment emergent ocular AE's


Secondary Outcome Measures:
  • 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


Enrollment: 350
Study Start Date: July 2010
Study Completion Date: July 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01163643

Locations
United States, New York
Bausch & Lomb
Rochester, New York, United States, 14609
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Tuyen Ong, MD Bausch & Lomb Incorporated
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01163643     History of Changes
Other Study ID Numbers: 637
Study First Received: July 9, 2010
Last Updated: November 22, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Syndrome
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Disease
Pathologic Processes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases

ClinicalTrials.gov processed this record on September 29, 2014