Trial Outcomes & Findings for A Six-Week Safety Study of an Investigational Ophthalmic Solution (NCT NCT01698814)

Results Overview

An adverse event was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

518 participants

Primary outcome timeframe

An average of 6 weeks

Results posted on

2014-03-27

Participant Flow

Subjects were recruited from 15 study centers located in the United States.

Of the 518 enrolled subjects, 18 subjects were exited from the study as screen failures. This reporting group includes all randomized subjects.

Participant milestones

Participant milestones
Measure	AL-4943A AL-4943A Ophthalmic Solution, one drop instilled in both eyes once daily for up to 6 weeks	AL-4943A Vehicle AL-4943A Ophthalmic Solution Vehicle, one drop instilled in both eyes once daily for up to 6 weeks
Overall Study STARTED	331	169
Overall Study COMPLETED	329	166
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	AL-4943A AL-4943A Ophthalmic Solution, one drop instilled in both eyes once daily for up to 6 weeks	AL-4943A Vehicle AL-4943A Ophthalmic Solution Vehicle, one drop instilled in both eyes once daily for up to 6 weeks
Overall Study Adverse Event	0	2
Overall Study Lost to Follow-up	0	1
Overall Study Pregnancy	1	0
Overall Study Randomized in error	1	0

Baseline Characteristics

A Six-Week Safety Study of an Investigational Ophthalmic Solution

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AL-4943A n=330 Participants AL-4943A Ophthalmic Solution, one drop instilled in both eyes once daily for up to 6 weeks	AL-4943A Vehicle n=169 Participants AL-4943A Ophthalmic Solution Vehicle, one drop instilled in both eyes once daily for up to 6 weeks	Total n=499 Participants Total of all reporting groups
Age, Customized 2-11 years	47 participants n=5 Participants	21 participants n=7 Participants	68 participants n=5 Participants
Age, Customized 12-17 years	4 participants n=5 Participants	3 participants n=7 Participants	7 participants n=5 Participants
Age, Customized 18-64 years	272 participants n=5 Participants	141 participants n=7 Participants	413 participants n=5 Participants
Age, Customized ≥65 years	7 participants n=5 Participants	4 participants n=7 Participants	11 participants n=5 Participants
Sex: Female, Male Female	214 Participants n=5 Participants	111 Participants n=7 Participants	325 Participants n=5 Participants
Sex: Female, Male Male	116 Participants n=5 Participants	58 Participants n=7 Participants	174 Participants n=5 Participants

PRIMARY outcome

Timeframe: An average of 6 weeks

Population: This reporting group includes all randomized subjects who received study medication.

An adverse event was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.

Outcome measures

Outcome measures
Measure	AL-4943A n=330 Participants AL-4943A Ophthalmic Solution, one drop instilled in both eyes once daily for up to 6 weeks	AL-4943A Vehicle n=169 Participants AL-4943A Ophthalmic Solution Vehicle, one drop instilled in both eyes once daily for up to 6 weeks
Adverse Events Deaths	0 participants	0 participants
Adverse Events Non-Fatal Serious Adverse Events	0 participants	0 participants
Adverse Events Discontinuations Due to an Adverse Event	0 participants	2 participants

Adverse Events

AL-4943A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

AL-4943A Vehicle

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

Terri Pasquine, Sr. Clinical Project Lead

Alcon Research, Ltd.

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