Cataract
Conditions
Brief summary
Study of T-PRED(TM) compared to Pred Forte(R)
Interventions
DRUGT-PRED
T-PRED sterile ophthalmic solution
DRUGPred Forte
Pred Forte sterile ophthalmic solution
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age
Exclusion criteria
* No active or adverse disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Aqueous Humor Prednisolone Acetate Concentration | 4 hours |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| T-Pred Tobramycin prednisolone acetate combination
T-PRED: sterile ophthalmic solution | 32 |
| Pred Forte Prednisolone acetate
Pred Forte: sterile ophthalmic solution | 32 |
| Total | 64 |
Baseline characteristics
| Characteristic | T-Pred | Pred Forte | Total |
|---|---|---|---|
| Age, Continuous | 66.6 years STANDARD_DEVIATION 10 | 65.7 years STANDARD_DEVIATION 10.9 | 66.1 years STANDARD_DEVIATION 10.4 |
| Sex: Female, Male Female | 19 Participants | 23 Participants | 42 Participants |
| Sex: Female, Male Male | 13 Participants | 9 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 32 |
| other Total, other adverse events | 0 / 32 | 0 / 32 |
| serious Total, serious adverse events | 0 / 32 | 0 / 32 |
Outcome results
Primary
Mean Aqueous Humor Prednisolone Acetate Concentration
Time frame: 4 hours
Population: Analysis Population was defined as all participants who received investigational product and on whom successful anterior chamber tap were performed at the designated time point
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| T-Pred | Mean Aqueous Humor Prednisolone Acetate Concentration | 102.5 ng/mL | Standard Deviation 5.6 |
| Pred Forte | Mean Aqueous Humor Prednisolone Acetate Concentration | 127.5 ng/mL | Standard Deviation 66.7 |