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The purpose of this study is to investigate the safety and efficacy of an ophthalmic solution in dry eye disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bromfenac ophthalmic solution 0.06% | Experimental | bromfenac ophthalmic solution 0.06% bilaterally twice a day |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bromfenac ophthalmic solution 0.06% | Drug | bromfenac ophthalmic solution 0.06% bilaterally twice a day |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Average Lissamine Green Staining in the Study Eye | Lissamine green staining was assessed for both eyes at each study visit. The Investigator inserted a lissamine green staining strip into the inferior conjunctival cul-de-sac. Staining density for each of the 6 regions of the conjunctiva (temporal, superior temporal, inferior temporal, superior nasal, inferior nasal, and nasal) was graded from 0 to 3 approximately 2.5 minutes after strip instillation according to the National Eye Institute (NEI) chart and grid. The scale for total scoring ranged from 0 to 18 units summed across all 6 conjunctival regions, with a higher score suggesting a more dry eye condition. An average of the 6 areas was computed, providing an average score of 0-3 units. The study eye utilized for analysis was selected by pre-specified criteria. | Baseline, Day 42 |
| Percentage of Participants With at Least One Adverse Event | 52 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline to Worst Region in Lissamine Green Staining in the Study Eye | Lissamine green staining was assessed for both eyes at each study visit. The Investigator inserted a lissamine green staining strip into the inferior conjunctival cul-de-sac. Staining density for each of the 6 regions of the conjunctiva (temporal, superior temporal, inferior temporal, superior nasal, inferior nasal, and nasal) was graded from 0 to 3 approximately 2.5 minutes after strip instillation according to the National Eye Institute (NEI) chart and grid. The scale for worst region of Lissamine Green staining ranged from 0 to 3 units, with a higher score suggesting a more dry eye condition.The worst region of lissamine green staining was determined at the baseline visit. The study eye utilized for analysis was selected based on pre-specified criteria. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tim McNamara, PharmD | ISTA Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ISTA Pharmaceuticals, Inc. | Irvine | California | 92618 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bromfenac Ophthalmic Solution 0.06% | bromfenac ophthalmic solution 0.06% bilaterally twice a day |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Bromfenac Ophthalmic Solution 0.06% | bromfenac ophthalmic solution 0.06% bilaterally twice a day |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change From Baseline in Average Lissamine Green Staining in the Study Eye | Lissamine green staining was assessed for both eyes at each study visit. The Investigator inserted a lissamine green staining strip into the inferior conjunctival cul-de-sac. Staining density for each of the 6 regions of the conjunctiva (temporal, superior temporal, inferior temporal, superior nasal, inferior nasal, and nasal) was graded from 0 to 3 approximately 2.5 minutes after strip instillation according to the National Eye Institute (NEI) chart and grid. The scale for total scoring ranged from 0 to 18 units summed across all 6 conjunctival regions, with a higher score suggesting a more dry eye condition. An average of the 6 areas was computed, providing an average score of 0-3 units. The study eye utilized for analysis was selected by pre-specified criteria. | All participants enrolled were included in the analysis population, with last observation carried forward applied for missing values. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 42 |
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52 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bromfenac Ophthalmic Solution 0.06% | bromfenac ophthalmic solution 0.06% bilaterally twice a day |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
Participants could co-administer Refresh Plus OTC eyedrops as needed during treatment/follow-up. Only 29 participants dosed all 42 days. Environmental factors influencing dry eye (eg, temperature, humidity, season, geography) were not controlled.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Bausch Health | susan.harris@bauschhealth.com |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Baseline, 42 days |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| OG000 |
| Bromfenac Ophthalmic Solution 0.06% |
bromfenac ophthalmic solution 0.06% bilaterally twice a day |
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| Primary | Percentage of Participants With at Least One Adverse Event | Posted | Count of Participants | Participants | 52 days |
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| Secondary | Mean Change From Baseline to Worst Region in Lissamine Green Staining in the Study Eye | Lissamine green staining was assessed for both eyes at each study visit. The Investigator inserted a lissamine green staining strip into the inferior conjunctival cul-de-sac. Staining density for each of the 6 regions of the conjunctiva (temporal, superior temporal, inferior temporal, superior nasal, inferior nasal, and nasal) was graded from 0 to 3 approximately 2.5 minutes after strip instillation according to the National Eye Institute (NEI) chart and grid. The scale for worst region of Lissamine Green staining ranged from 0 to 3 units, with a higher score suggesting a more dry eye condition.The worst region of lissamine green staining was determined at the baseline visit. The study eye utilized for analysis was selected based on pre-specified criteria. | All participants enrolled were included in the analysis population, with last observation carried forward applied for missing values. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 42 days |
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| 0 |
| 38 |
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| 2 |
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Please contact sponsor directly for details.