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The objective of this study is to assess the safety and efficacy of testosterone 0.03% ophthalmic solution compared to vehicle for the treatment of meibomian gland dysfunction.
Meibomian gland secretion plays a crucial role in the health of the ocular surface and function of the tear film. The lipid secreted by the meibomian glands has many crucial roles: 1) to retard evaporation from the preocular surface; 2) lower the surface tension of tears; 3) prevent spill-over of tears from the lid margin; 4) prevent the contamination of the tear film by sebaceous lipids; 5) prevent damage to the skin of the lid margin. In dry eye syndrome, blepharitis, meibomian gland dysfunction, and meibomitis the glands are the central pathophysiology of disease and thus a potential target for therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| testosterone ophthalmic solution | Experimental | testosterone ophthalmic solution 0.03% |
|
| vehicle | Placebo Comparator | vehicle of testosterone ophthalmic solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| testosterone ophthalmic solution | Drug | testosterone ophthalmic solution for 128 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Meibomian Gland Secretion Appearance at Visit 4 (Day 168) | The average of the secretion color, quality, and viscosity of the worst gland in the worst eye. All scales were numerical analog, 0-3, where 0=normal and 3=worst. | 168 days |
| Ocular Discomfort Score at Visit 4 | Ocular Discomfort Score on a 0-4 scale where 0=none and 4=constant discomfort at Visit 4 (Day 168) | 168 days |
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Inclusion Criteria (subjects must):
Exclusion Criteria (subjects may not):
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| Name | Affiliation | Role |
|---|---|---|
| H. Jerome Crampton, MD | ORA, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ophthalmic Research Associates | Andover | Massachusetts | 01810 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Testosterone Ophthalmic Solution | testosterone ophthalmic solution 0.03% Participants received 1 drop of testosterone ophthalmic solution in each eye for approximately 168 days. |
| FG001 | Vehicle | vehicle of testosterone ophthalmic solution Participants received 1 drop of vehicle of testosterone ophthalmic solution in each eye for approximately 168 days. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Testosterone Ophthalmic Solution | testosterone ophthalmic solution 0.03% Participants received 1 drop of testosterone ophthalmic solution in each eye for approximately 168 days. |
| BG001 | Vehicle |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Meibomian Gland Secretion Appearance at Visit 4 (Day 168) | The average of the secretion color, quality, and viscosity of the worst gland in the worst eye. All scales were numerical analog, 0-3, where 0=normal and 3=worst. | Posted | Mean | Standard Deviation | units on a scale | 168 days |
|
Adverse events were collected from the signing of the informed consent for to the end of treatment, approximately 6 months
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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 | Testosterone Ophthalmic Solution | testosterone ophthalmic solution 0.03% Participants received 1 drop of testosterone ophthalmic solution in each eye for approximately 168 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Essential tremor | Nervous system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Visual acuity reduced | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark Abelson | Andover Eye | 9784750705 |
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| ID | Term |
|---|---|
| D000080343 | Meibomian Gland Dysfunction |
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
| D007766 | Lacrimal Apparatus Diseases |
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| vehicle of testosterone ophthalmic solution | Drug | vehicle of testosterone ophthalmic solution for 128 days |
|
| Withdrawal by Subject |
|
| Administrative |
|
vehicle of testosterone ophthalmic solution
Participants received 1 drop of vehicle of testosterone ophthalmic solution in each eye for approximately 168 days.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Ocular Discomfort Score at Visit 4 | Ocular Discomfort Score on a 0-4 scale where 0=none and 4=constant discomfort at Visit 4 (Day 168) | Posted | Mean | Standard Deviation | score on a scale | 168 days |
|
|
|
| 2 |
| 30 |
| 5 |
| 30 |
| EG001 | Vehicle | vehicle of testosterone ophthalmic solution Participants received 1 drop of vehicle of testosterone ophthalmic solution in each eye for approximately 168 days. | 0 | 30 | 5 | 30 |
| Supraventricular tachycardia | Cardiac disorders | Systematic Assessment |
|
| Electrolyte imbalance | Metabolism and nutrition disorders | Systematic Assessment |
|
| Sinusitis | Infections and infestations | Systematic Assessment |
|
| Rhinitis | Infections and infestations | Systematic Assessment |
|
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