Trial Outcomes & Findings for Study of T-PRED(TM) Compared to Pred Forte(R) II (NCT NCT00854061)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

172 participants

Primary outcome timeframe

35 days

Results posted on

2020-10-20

Participant milestones
Measure	All Study Participants Participants received both treatment groups, one in each eye. 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 (surgery); 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.
Overall Study STARTED	172
Overall Study Completed 1st Surgery (T-PRED in One Eye and Pred Forte in the Other Eye)	162
Overall Study Completed 2nd Surgery (T-PRED and Pred Forte in Opposite Eyes Compared to 1st Surgery)	149
Overall Study COMPLETED	149
Overall Study NOT COMPLETED	23

Withdrawal data not reported

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

Baseline characteristics by cohort
Measure	Overall n=172 Participants Participants received both treatment groups, one in each eye. The treatment assigned to an eye (right or left) was randomly assigned.
Age, Continuous	70.1 years STANDARD_DEVIATION 9.6 • n=39 Participants
Sex: Female, Male Female	112 Participants n=39 Participants
Sex: Female, Male Male	60 Participants n=39 Participants

Timeframe: 35 days

Population: Participants received both treatment groups, one in each eye. The treatment assigned to an eye (right or left) was randomly assigned.

Outcome measures
Measure	T-Pred n=81 eyes Tobramycin prednisolone acetate combination T-Pred: sterile ophthalmic solution	Pred Forte n=81 eyes Prednisolone acetate Pred Forte: sterile ophthalmic solution
Means Aqueous Humor Prednisolone Acetate Concentration	100.02 ng/mL Standard Deviation 9.61	131.65 ng/mL Standard Deviation 9.61

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events
Measure	T-Pred n=162 participants at risk	Pred-Forte n=162 participants at risk
Eye disorders IOL dislocation	0.62% 1/162 • 35 days The safety population was comprised of participants who received study treatment and had at least one post-baseline safety assessment. Participants received both treatment groups, one in each eye. The treatment assigned to an eye (right or left) was randomly assigned.g	0.00% 0/162 • 35 days The safety population was comprised of participants who received study treatment and had at least one post-baseline safety assessment. Participants received both treatment groups, one in each eye. The treatment assigned to an eye (right or left) was randomly assigned.g
Eye disorders Vitritis	0.00% 0/162 • 35 days The safety population was comprised of participants who received study treatment and had at least one post-baseline safety assessment. Participants received both treatment groups, one in each eye. The treatment assigned to an eye (right or left) was randomly assigned.g	0.62% 1/162 • 35 days The safety population was comprised of participants who received study treatment and had at least one post-baseline safety assessment. Participants received both treatment groups, one in each eye. The treatment assigned to an eye (right or left) was randomly assigned.g

Adverse event data not reported

Bausch Health

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

Restriction type: OTHER