Dry Eye Syndrome
Conditions
Brief 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.
Interventions
DRUG0.3% BOL-303242-X ophthalmic suspension
0.3% BOL-303242-X ophthalmic suspension BID for 12 weeks.
DRUG2% BOL-303242-X ophthalmic suspension
2% BOL-303242-X ophthalmic suspension BID for 12 weeks.
Placebo Comparator: Vehicle BID for 12 weeks.
DRUG1% BOL-303242-X ophthalmic suspension
1% BOL-303242-X ophthalmic suspension BID for 12 weeks.
DRUG2% BOL-303242-X ophthalmic suspension AM
2% BOL-303242-X ophthalmic suspension once daily (QD) AM and vehicle QD in PM for 12 weeks.
DRUG2% BOL-303242-X ophthalmic suspension PM
Vehicle QD AM and 2% BOL-303242-X ophthalmic suspension QD in PM for 12 weeks.
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Corneal Staining Score | 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. |
| Mean Worst Visual Analog Scale(VAS) Dry Eye Symptom | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 2% BOL-303242-X Ophthalmic Suspension 2% BOL-303242-X ophthalmic suspension
2% BOL-303242-X ophthalmic suspension: 2% BOL-303242-X ophthalmic suspension BID for 12 weeks. | 68 |
| 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 AM: 2% BOL-303242-X ophthalmic suspension once daily (QD) AM and vehicle QD in PM for 12 weeks. | 37 |
| 2% BOL-303242-X Ophthalmic Suspension PM Vehicle in the AM and 2% BOL-303242-X ophthalmic suspension in the PM.
2% BOL-303242-X ophthalmic suspension PM: Vehicle QD AM and 2% BOL-303242-X ophthalmic suspension QD in PM for 12 weeks. | 35 |
| 1% BOL-303242-X Ophthalmic Suspension 1% BOL-303242-X ophthalmic suspension
1% BOL-303242-X ophthalmic suspension: 1% BOL-303242-X ophthalmic suspension BID for 12 weeks. | 74 |
| 0.3% BOL-303242-X Ophthalmic Suspension 0.3% BOL-303242-X ophthalmic suspension
0.3% BOL-303242-X ophthalmic suspension: 0.3% BOL-303242-X ophthalmic suspension BID for 12 weeks. | 69 |
| Vehicle Vehicle twice daily (BID)
Placebo Comparator: Vehicle: Placebo Comparator: Vehicle BID for 12 weeks. | 73 |
| Total | 356 |
Baseline characteristics
| Characteristic | 2% BOL-303242-X Ophthalmic Suspension | 2% BOL-303242-X Ophthalmic Suspension in the Morning | 2% BOL-303242-X Ophthalmic Suspension PM | 1% BOL-303242-X Ophthalmic Suspension | 0.3% BOL-303242-X Ophthalmic Suspension | Vehicle | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 48.6 years STANDARD_DEVIATION 17.79 | 50.6 years STANDARD_DEVIATION 16.99 | 51.8 years STANDARD_DEVIATION 18.1 | 46.3 years STANDARD_DEVIATION 17.64 | 46.5 years STANDARD_DEVIATION 15.91 | 49.5 years STANDARD_DEVIATION 17.56 | 48.4 years STANDARD_DEVIATION 17.29 |
| Sex: Female, Male Female | 45 Participants | 26 Participants | 24 Participants | 49 Participants | 48 Participants | 50 Participants | 242 Participants |
| Sex: Female, Male Male | 23 Participants | 11 Participants | 11 Participants | 25 Participants | 21 Participants | 23 Participants | 114 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 67 | 2 / 37 | 1 / 34 | 2 / 73 | 3 / 69 | 5 / 71 |
| serious Total, serious adverse events | 0 / 67 | 0 / 37 | 0 / 34 | 0 / 73 | 0 / 69 | 0 / 71 |
Outcome results
Primary
Mean Corneal Staining Score
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.
Time frame: 12 weeks
Population: Randomized participants with Week 12 results were included, with no imputation of missing data at Week 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 2% BOL-303242-X Ophthalmic Suspension | Mean Corneal Staining Score | 4.0 score on a scale | Standard Deviation 3.19 |
| 2% BOL-303242-X Ophthalmic Suspension in the Morning | Mean Corneal Staining Score | 3.9 score on a scale | Standard Deviation 3.87 |
| 2% BOL-303242-X Ophthalmic Suspension PM | Mean Corneal Staining Score | 3.9 score on a scale | Standard Deviation 3.66 |
| 1% BOL-303242-X Ophthalmic Suspension | Mean Corneal Staining Score | 4.4 score on a scale | Standard Deviation 3.53 |
| 0.3% BOL-303242-X Ophthalmic Suspension | Mean Corneal Staining Score | 4.1 score on a scale | Standard Deviation 3.03 |
| Vehicle | Mean Corneal Staining Score | 3.7 score on a scale | Standard Deviation 3.33 |
Primary
Mean Worst Visual Analog Scale(VAS) Dry Eye Symptom
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.
Time frame: 12 weeks
Population: Randomized participants with Week 12 results were included, with no imputation of missing data at Week 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 2% BOL-303242-X Ophthalmic Suspension | Mean Worst Visual Analog Scale(VAS) Dry Eye Symptom | 2.256 score on a scale | Standard Deviation 2.3172 |
| 2% BOL-303242-X Ophthalmic Suspension in the Morning | Mean Worst Visual Analog Scale(VAS) Dry Eye Symptom | 2.954 score on a scale | Standard Deviation 2.4688 |
| 2% BOL-303242-X Ophthalmic Suspension PM | Mean Worst Visual Analog Scale(VAS) Dry Eye Symptom | 2.290 score on a scale | Standard Deviation 2.4885 |
| 1% BOL-303242-X Ophthalmic Suspension | Mean Worst Visual Analog Scale(VAS) Dry Eye Symptom | 2.407 score on a scale | Standard Deviation 2.607 |
| 0.3% BOL-303242-X Ophthalmic Suspension | Mean Worst Visual Analog Scale(VAS) Dry Eye Symptom | 2.535 score on a scale | Standard Deviation 2.5565 |
| Vehicle | Mean Worst Visual Analog Scale(VAS) Dry Eye Symptom | 2.026 score on a scale | Standard Deviation 2.1849 |