Cataract
Conditions
Brief summary
Study of T-PRED(TM) Compared to Pred Forte(R)
Detailed description
This study was a multi-center, randomized, double-masked, bioequivalence study. A total of 172 participants undergoing bilateral cataract surgery were assigned investigational product to each eye according to a computer-generated randomization list for each of 2 study variables: treatment with T-PRED or Pred Forte in the first eye undergoing cataract extraction and the aqueous humor sampling time point. The investigator determined which eye was clinically suited for the first operative procedure; treatment of this eye was randomized to either T-PRED or Pred Forte. The second eye received the other study treatment (RP if the first eye received T-PRED; T-PRED if the first eye received Pred Forte) at the time of the second cataract extraction.
Interventions
DRUGT-Pred
sterile ophthalmic solution
DRUGPred Forte
sterile ophthalmic solution
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
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 or older
Exclusion criteria
* No active or adverse disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Means Aqueous Humor Prednisolone Acetate Concentration | 35 days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Participants received both treatment groups, one in each eye. The treatment assigned to an eye (right or left) was randomly assigned. | 172 |
| Total | 172 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 70.1 years STANDARD_DEVIATION 9.6 |
| Sex: Female, Male Female | 112 Participants |
| Sex: Female, Male Male | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 162 | 0 / 162 |
| serious Total, serious adverse events | 1 / 162 | 1 / 162 |
Outcome results
Primary
Means Aqueous Humor Prednisolone Acetate Concentration
Time frame: 35 days
Population: Participants received both treatment groups, one in each eye. The treatment assigned to an eye (right or left) was randomly assigned.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| T-Pred | Means Aqueous Humor Prednisolone Acetate Concentration | 100.02 ng/mL | Standard Deviation 9.61 |
| Pred Forte | Means Aqueous Humor Prednisolone Acetate Concentration | 131.65 ng/mL | Standard Deviation 9.61 |