Trial Outcomes & Findings for Study of T-PRED(TM) Compared to Pred Forte(R) (NCT NCT00699803)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

64 participants

Primary outcome timeframe

4 hours

Results posted on

2020-09-25

Participant Flow

Participant milestones

Participant milestones
Measure	T-Pred Tobramycin prednisolone acetate combination T-PRED: sterile ophthalmic solution	Pred Forte Prednisolone acetate Pred Forte: sterile ophthalmic solution
Overall Study STARTED	32	32
Overall Study COMPLETED	30	26
Overall Study NOT COMPLETED	2	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of T-PRED(TM) Compared to Pred Forte(R)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	T-Pred n=32 Participants Tobramycin prednisolone acetate combination T-PRED: sterile ophthalmic solution	Pred Forte n=32 Participants Prednisolone acetate Pred Forte: sterile ophthalmic solution	Total n=64 Participants Total of all reporting groups
Age, Continuous	66.6 years STANDARD_DEVIATION 10.0 • n=93 Participants	65.7 years STANDARD_DEVIATION 10.9 • n=4 Participants	66.1 years STANDARD_DEVIATION 10.4 • n=27 Participants
Sex: Female, Male Female	19 Participants n=93 Participants	23 Participants n=4 Participants	42 Participants n=27 Participants
Sex: Female, Male Male	13 Participants n=93 Participants	9 Participants n=4 Participants	22 Participants n=27 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	T-Pred n=30 Participants Tobramycin prednisolone acetate combination T-PRED: sterile ophthalmic solution	Pred Forte n=26 Participants Prednisolone acetate T-PRED: sterile ophthalmic solution
Mean Aqueous Humor Prednisolone Acetate Concentration	102.5 ng/mL Standard Deviation 5.6	127.5 ng/mL Standard Deviation 66.7

Adverse Events

T-Pred

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pred Forte

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Study Director

Bausch Health

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Contact sponsor directly for details.
Publication restrictions are in place

Restriction type: OTHER