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Completed

NCT Number: NCT01163643

Study to Assess 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.

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Key information

Conditions

Dry Eye Syndrome Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Bausch & Lomb

Rochester, New York, 14609, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

0.3% BOL-303242-X ophthalmic suspension

Drug

0.3% BOL-303242-X ophthalmic suspension BID for 12 weeks.

2% BOL-303242-X ophthalmic suspension

Drug

2% BOL-303242-X ophthalmic suspension BID for 12 weeks.

Placebo Comparator: Vehicle

Drug

Placebo Comparator: Vehicle BID for 12 weeks.

1% BOL-303242-X ophthalmic suspension

Drug

1% BOL-303242-X ophthalmic suspension BID for 12 weeks.

2% BOL-303242-X ophthalmic suspension AM

Drug

2% BOL-303242-X ophthalmic suspension once daily (QD) AM and vehicle QD in PM for 12 weeks.

2% BOL-303242-X ophthalmic suspension PM

Drug

Vehicle QD AM and 2% BOL-303242-X ophthalmic suspension QD in PM for 12 weeks.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 16, 2010
Registry last updated
Sep 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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