Phase 2
N=356
Study to Assess the Safety and Efficacy of BOL-303242-X Ophthalmic Suspension in Dry Eye Syndrome
Dry Eye Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01163643 ↗Enrolled (actual)
356
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Mean Corneal Staining Score — 4.0; 3.9; 3.9; 4.4 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 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 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bausch & Lomb Incorporated
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Corneal Staining Score |
4.0; 3.9; 3.9; 4.4; 4.1; 3.7 | — |
| PRIMARY Mean Worst Visual Analog Scale(VAS) Dry Eye Symptom |
2.256; 2.954; 2.290; 2.407; 2.535; 2.026 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01163643). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.