Trial Outcomes & Findings for Study of Difluprednate in the Treatment of Inflammation Following Ocular Surgery (ST-601A-002b) (NCT NCT00430092)

Results Overview

Measured on a 0 to 4 scale: "0" is ≤ 1 cell; "1" is 2-10 cells; "2" is 11-20 cells; "3" is 21-50 cells; "4" is \> 50 cells.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

219 participants

Primary outcome timeframe

Day 8 (QID)

Results posted on

2009-07-02

Participant Flow

First subject enrolled January 24, 2007 and last subject completed September 20, 2007 at 11 sites in the United States.

Subjects enrolled if, 24 hours after ocular surgery, they had an anterior chamber cell grade of ≥ "2" and met the protocol inclusion and exclusion criteria.

Participant milestones

Participant milestones
Measure	Difluprednate 0.05% BID Difluprednate 0.05% 1 drop BID for 14 days	Difluprednate 0.05% QID Difluprednate 0.05% 1 drop QID for 14 days	Placebo Placebo for 14 days. Placebo was administered BID for 14 days and QID for 14 days. The outcomes of the 2 placebo groups were examined and were determined to be statistically indistinguishable so the placebo groups were pooled for comparison with the difluprednate groups.
Overall Study STARTED	54	52	113
Overall Study COMPLETED	48	48	56
Overall Study NOT COMPLETED	6	4	57

Reasons for withdrawal

Reasons for withdrawal
Measure	Difluprednate 0.05% BID Difluprednate 0.05% 1 drop BID for 14 days	Difluprednate 0.05% QID Difluprednate 0.05% 1 drop QID for 14 days	Placebo Placebo for 14 days. Placebo was administered BID for 14 days and QID for 14 days. The outcomes of the 2 placebo groups were examined and were determined to be statistically indistinguishable so the placebo groups were pooled for comparison with the difluprednate groups.
Overall Study Adverse Event	0	0	1
Overall Study Lack of Efficacy	5	2	54
Overall Study Lost to Follow-up	1	0	0
Overall Study Protocol Violation	0	1	1
Overall Study Withdrawal by Subject	0	1	1

Baseline Characteristics

Study of Difluprednate in the Treatment of Inflammation Following Ocular Surgery (ST-601A-002b)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Difluprednate 0.05% BID n=54 Participants Difluprednate 0.05% 1 drop BID for 14 days	Difluprednate 0.05% QID n=52 Participants Difluprednate 0.05% 1 drop QID for 14 days	Placebo n=113 Participants Placebo for 14 days. Placebo was administered BID for 14 days and QID for 14 days. The outcomes of the 2 placebo groups were examined and were determined to be statistically indistinguishable so the placebo groups were pooled for comparison with the difluprednate groups.	Total n=219 Participants Total of all reporting groups
Age Continuous	70.7 years STANDARD_DEVIATION 0 • n=5 Participants	68.4 years STANDARD_DEVIATION 0 • n=7 Participants	69.9 years STANDARD_DEVIATION 0 • n=5 Participants	69.8 years STANDARD_DEVIATION 0 • n=4 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	29 Participants n=7 Participants	70 Participants n=5 Participants	129.0 Participants n=4 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	23 Participants n=7 Participants	43 Participants n=5 Participants	90.0 Participants n=4 Participants

PRIMARY outcome

Timeframe: Day 8 (QID)

Population: The ITT population was defined as all randomized subjects who received at least 1 administration of the study drug. Analysis of the ITT population, with LOCF for missing data, was conducted for all primary and secondary endpoints at Days 3, 8, 15, and 29.

Measured on a 0 to 4 scale: "0" is ≤ 1 cell; "1" is 2-10 cells; "2" is 11-20 cells; "3" is 21-50 cells; "4" is \> 50 cells.

Outcome measures

Outcome measures
Measure	Difluprednate 0.05% BID Difluprednate 0.05% 1 drop BID for 14 days	Difluprednate 0.05% QID n=52 Participants Difluprednate 0.05% 1 drop QID for 14 days	Placebo n=113 Participants Placebo for 14 days. Placebo was administered BID for 14 days and QID for 14 days. The outcomes of the 2 placebo groups were examined and were determined to be statistically indistinguishable so the placebo groups were pooled for comparison with the difluprednate groups.
Anterior Chamber Cell Grade of "0" on Day 8 (Difluprednate QID vs Placebo). Proportion of Subjects w/AC cell grade=0 on Day 8	0 participants	18 participants	7 participants

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jeremy Brace

Sirion Therapeutics, Inc.

Phone: 813-496-7325

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60