Meibomian Gland Dysfunction
Conditions
Keywords
Meibomian Gland Dysfunction, Dry Eye Syndrome
Brief summary
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.
Detailed description
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.
Interventions
DRUGtestosterone ophthalmic solution
testosterone ophthalmic solution for 128 days
DRUGvehicle of testosterone ophthalmic solution
vehicle of testosterone ophthalmic solution for 128 days
Sponsors
ORA, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(subjects must): * Be ≥ 60 years of age * Have a corrected visual acuity of LogMAR +0.5 (ETDRS) * Have a documented history of Meibomian Gland Dysfunction * Have a TFBUT ≤ 5 seconds * Have an ocular discomfort score ≥ 1 * Have an IOP ≤ 25 mmHg at Visit 1 in both eyes * Report use of and/or desire to use an artificial tears
Exclusion criteria
(subjects may not): * Have contraindications to the use of the study medications * Have a known allergy or sensitivity to the study medications * Have any ocular infections, or active ocular inflammation * Have used ocular medications within 24 hours prior to Visit 1 * Be a current contact lens wearer * Require the use of any other ophthalmic medication, other than tear substitutes and study medication provided, for the duration of the trial * Have used systemic or topical antihistamines or steroids 48 hours prior to Visit 1 or require the use of systemic or topical antihistamines or steroids during the course of the study * Have a history of prostate cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Meibomian Gland Secretion Appearance at Visit 4 (Day 168) | 168 days | 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. |
| Ocular Discomfort Score at Visit 4 | 168 days | Ocular Discomfort Score on a 0-4 scale where 0=none and 4=constant discomfort at Visit 4 (Day 168) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Testosterone Ophthalmic Solution testosterone ophthalmic solution 0.03%
Participants received 1 drop of testosterone ophthalmic solution in each eye for approximately 168 days. | 30 |
| Vehicle vehicle of testosterone ophthalmic solution
Participants received 1 drop of vehicle of testosterone ophthalmic solution in each eye for approximately 168 days. | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administrative | 2 | 1 |
| Overall Study | Adverse Event | 5 | 2 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Testosterone Ophthalmic Solution | Vehicle | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 17 Participants | 18 Participants | 35 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 12 Participants | 25 Participants |
| Age, Continuous | 69.57 years STANDARD_DEVIATION 6.73 | 68.10 years STANDARD_DEVIATION 6.764 | 68.83 years STANDARD_DEVIATION 6.73 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants | 29 Participants | 58 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 29 Participants | 29 Participants | 58 Participants |
| Region of Enrollment United States | 30 participants | 30 participants | 60 participants |
| Sex: Female, Male Female | 20 Participants | 20 Participants | 40 Participants |
| Sex: Female, Male Male | 10 Participants | 10 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 30 | 5 / 30 |
| serious Total, serious adverse events | 2 / 30 | 0 / 30 |
Outcome results
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.
Time frame: 168 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testosterone Ophthalmic Solution | Meibomian Gland Secretion Appearance at Visit 4 (Day 168) | 0.80 units on a scale | Standard Deviation 0.5 |
| Vehicle | Meibomian Gland Secretion Appearance at Visit 4 (Day 168) | 0.96 units on a scale | Standard Deviation 0.67 |
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)
Time frame: 168 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testosterone Ophthalmic Solution | Ocular Discomfort Score at Visit 4 | 1.70 score on a scale | Standard Deviation 0.6 |
| Vehicle | Ocular Discomfort Score at Visit 4 | 1.33 score on a scale | Standard Deviation 0.6 |