Trial Outcomes & Findings for Efficacy and Safety Assessment of T2347 Versus Xalacom® in Ocular Hypertensive or Glaucomatous Patients (NCT NCT02278614)

Results Overview

the non-inferiority of T2347 unpreserved eye drops compared with Xalacom® on change in mean IOP at 9.00 am (± 1 hour) between the baseline (Day 0) and Day 84 in the worse eye. Two relevant time points are considered for this primary criteria: D0 and Day 84.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

242 participants

Primary outcome timeframe

Day 84

Results posted on

2017-04-28

Participant Flow

Participant milestones

Participant milestones
Measure	T2347 T2347: fixed combination Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops T2347: T2347 eye drop solution is presented in SDU. It is supplied in 0.20 ml single use polyethylene containers.	Xalacom Xalacom®: Latanoprost 0.005% + Timolol 0.5% preserved eye drops Xalacom: Xalacom® 0.01% eye drop solution is supplied in 2.5 ml multidose container.
Overall Study STARTED	127	115
Overall Study COMPLETED	122	110
Overall Study NOT COMPLETED	5	5

Reasons for withdrawal

Reasons for withdrawal
Measure	T2347 T2347: fixed combination Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops T2347: T2347 eye drop solution is presented in SDU. It is supplied in 0.20 ml single use polyethylene containers.	Xalacom Xalacom®: Latanoprost 0.005% + Timolol 0.5% preserved eye drops Xalacom: Xalacom® 0.01% eye drop solution is supplied in 2.5 ml multidose container.
Overall Study Withdrawal by Subject	3	5
Overall Study Adverse Event	1	0
Overall Study left eye was not eligible	1	0

Baseline Characteristics

Efficacy and Safety Assessment of T2347 Versus Xalacom® in Ocular Hypertensive or Glaucomatous Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	T2347 n=127 Participants T2347: fixed combination Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops T2347: T2347 eye drop solution is presented in SDU. It is supplied in 0.20 ml single use polyethylene containers.	Xalacom n=115 Participants Xalacom®: Latanoprost 0.005% + Timolol 0.5% preserved eye drops Xalacom: Xalacom® 0.01% eye drop solution is supplied in 2.5 ml multidose container.	Total n=242 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	53 Participants n=5 Participants	43 Participants n=7 Participants	96 Participants n=5 Participants
Age, Categorical >=65 years	74 Participants n=5 Participants	72 Participants n=7 Participants	146 Participants n=5 Participants
Age, Continuous	65.8 years STANDARD_DEVIATION 10.8 • n=5 Participants	67.2 years STANDARD_DEVIATION 10.6 • n=7 Participants	66.3 years STANDARD_DEVIATION 10.8 • n=5 Participants
Sex: Female, Male Female	80 Participants n=5 Participants	69 Participants n=7 Participants	149 Participants n=5 Participants
Sex: Female, Male Male	47 Participants n=5 Participants	46 Participants n=7 Participants	93 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 84

Population: The primary efficacy analysis (mean change in IOP from baseline to Day 84) was performed on the mITT set (236 patients). mITT set: All ITT patients with at least one baseline and one post-randomisation efficacy assessment following study treatment. 242 patients described in the participant flow correpsond to the ITT \& Safety set.

the non-inferiority of T2347 unpreserved eye drops compared with Xalacom® on change in mean IOP at 9.00 am (± 1 hour) between the baseline (Day 0) and Day 84 in the worse eye. Two relevant time points are considered for this primary criteria: D0 and Day 84.

Outcome measures

Outcome measures
Measure	T2347 n=124 Participants T2347: fixed combination Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops T2347: T2347 eye drop solution is presented in SDU. It is supplied in 0.20 ml single use polyethylene containers.	Xalacom n=112 Participants Xalacom®: Latanoprost 0.005% + Timolol 0.5% preserved eye drops Xalacom: Xalacom® 0.01% eye drop solution is supplied in 2.5 ml multidose container.
Non-inferiority of T2347 Compared With Xalacom® on Change in Mean IOP at 9.00 am (± 1 Hour) Between the Baseline (Day 0) and Day 84 in the Worse Eye	-0.51 mm Hg Standard Error 0.18	-0.52 mm Hg Standard Error 0.19

Adverse Events

T2347

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Xalacom

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	T2347 n=127 participants at risk T2347: fixed combination Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops T2347: T2347 eye drop solution is presented in SDU. It is supplied in 0.20 ml single use polyethylene containers.	Xalacom n=115 participants at risk Xalacom®: Latanoprost 0.005% + Timolol 0.5% preserved eye drops Xalacom: Xalacom® 0.01% eye drop solution is supplied in 2.5 ml multidose container.
Nervous system disorders Cerebral artery occlusion	0.00% 0/127	0.87% 1/115 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Director of Medical Operations

Laboratoires Théa

Phone: 04 73 98 50 89

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. All the results of the Trial are the sole and exclusive property of THEA, and cannot be used in whatever form without prior written agreement of THEA.
Publication restrictions are in place

Restriction type: OTHER