Trial Outcomes & Findings for Olopatadine Hydrochloride Ophthalmic Solution Study in Chinese Subjects (NCT NCT02322216)

Results Overview

Severity of ocular itching was evaluated as the worst score observed in the past 24 hours prior to each study visit. Ocular itching was assessed by the participant on a scale from 0-4, where 0=None and 4=Incapacitating itch. One eye (study eye) contributed to the analysis.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

383 participants

Primary outcome timeframe

Baseline, Day 14

Results posted on

2017-11-17

Participant Flow

Participants were recruited from 10 study centers located in China.

Of the 383 enrolled, 130 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants (253).

Participant milestones

Participant milestones
Measure	PATADAY Olopatadine hydrochloride ophthalmic solution 0.2% in the morning and olopatadine 0.2% Vehicle in the evening, 1 drop in each eye for 14 days	PATANOL Olopatadine hydrochloride ophthalmic solution 0.1%, 1 drop in each eye in the morning and evening, for 14 days
Overall Study STARTED	126	127
Overall Study Treated (Safety Set)	126	126
Overall Study Per Protocol Set (PPS)	123	122
Overall Study COMPLETED	124	123
Overall Study NOT COMPLETED	2	4

Reasons for withdrawal

Reasons for withdrawal
Measure	PATADAY Olopatadine hydrochloride ophthalmic solution 0.2% in the morning and olopatadine 0.2% Vehicle in the evening, 1 drop in each eye for 14 days	PATANOL Olopatadine hydrochloride ophthalmic solution 0.1%, 1 drop in each eye in the morning and evening, for 14 days
Overall Study Adverse Event	1	0
Overall Study Withdrawal by Subject	1	4

Baseline Characteristics

Olopatadine Hydrochloride Ophthalmic Solution Study in Chinese Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PATADAY n=123 Participants Olopatadine hydrochloride ophthalmic solution 0.2% in the morning and olopatadine 0.2% Vehicle in the evening, 1 drop in each eye for 14 days	PATANOL n=122 Participants Olopatadine hydrochloride ophthalmic solution 0.1%, 1 drop in each eye in the morning and evening, for 14 days	Total n=245 Participants Total of all reporting groups
Age, Continuous	32.5 years STANDARD_DEVIATION 13.72 • n=5 Participants	31.9 years STANDARD_DEVIATION 12.79 • n=7 Participants	32.2 years STANDARD_DEVIATION 13.24 • n=5 Participants
Sex: Female, Male Female	81 Participants n=5 Participants	86 Participants n=7 Participants	167 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants	36 Participants n=7 Participants	78 Participants n=5 Participants
Itching Score	3.35 units on a scale STANDARD_DEVIATION 0.377 • n=5 Participants	3.43 units on a scale STANDARD_DEVIATION 0.373 • n=7 Participants	3.39 units on a scale STANDARD_DEVIATION 0.376 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Day 14

Population: Per Protocol Set with non-missing data

Severity of ocular itching was evaluated as the worst score observed in the past 24 hours prior to each study visit. Ocular itching was assessed by the participant on a scale from 0-4, where 0=None and 4=Incapacitating itch. One eye (study eye) contributed to the analysis.

Outcome measures

Outcome measures
Measure	PATADAY n=118 Participants Olopatadine hydrochloride ophthalmic solution 0.2% in the morning and olopatadine 0.2% Vehicle in the evening, 1 drop in each eye for 14 days	PATANOL n=112 Participants Olopatadine hydrochloride ophthalmic solution 0.1%, 1 drop in each eye in the morning and evening, for 14 days
Change From Baseline in Worst Ocular Itching Score During the 24 Hours Prior at Day 14	-2.57 units on a scale Standard Error 0.090	-2.62 units on a scale Standard Error 0.092

Adverse Events

Pre-treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PATADAY

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PATANOL

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

Clinical Project Lead, GCRA-Pharma

Alcon, a Novartis Company

Phone: 1-888-451-3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Publication restrictions are in place

Restriction type: OTHER