Trial Outcomes & Findings for A Clinical Study of Systane® Lid Wipes in Brazil (NCT NCT02380261)

Results Overview

Participants were assessed by a dermatologist. Contact-dermatitis adverse reaction was characterized by the presence of one or more of the following symptoms or signs: strong itching sensation, erythema, edema, desquamation, papules or vesicles. Both eyes contributed to the analysis.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

35 participants

Primary outcome timeframe

Day 21

Results posted on

2016-11-18

Participant Flow

Participants were recruited from 1 study center located in Brazil.

Thirty-five participants were enrolled in this study. This reporting group includes all enrolled participants (35).

Participant milestones

Participant milestones
Measure	Systane Systane® Lid Wipes, 1 per eyelid, used once and discarded after each use, for 21 days
Overall Study STARTED	35
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Clinical Study of Systane® Lid Wipes in Brazil

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Systane n=35 Participants Systane® Lid Wipes, 1 per eyelid, used once and discarded after each use, for 21 days
Age, Customized Age 18-70	35 participants n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 21

Population: This analysis population includes all enrolled participants.

Participants were assessed by a dermatologist. Contact-dermatitis adverse reaction was characterized by the presence of one or more of the following symptoms or signs: strong itching sensation, erythema, edema, desquamation, papules or vesicles. Both eyes contributed to the analysis.

Outcome measures

Outcome measures
Measure	Systane n=35 Participants Systane® Lid Wipes, 1 per eyelid, used once and discarded after each use, for 21 days
Number of Participants With a Contact-dermatitis Adverse Reaction	0 participants

PRIMARY outcome

Timeframe: Day 21

Population: This analysis population includes all enrolled participants.

Participants were assessed by an ophthalmologist. Ocular clinical signs included palpebral edema, conjunctival edema, orbicular secretion, keratoconus, blepharitis, meibomitis, pterygium, hyperemia, chemosis, keratitis, secretion and lacrimation. Both eyes contributed to the analysis.

Outcome measures

Outcome measures
Measure	Systane n=35 Participants Systane® Lid Wipes, 1 per eyelid, used once and discarded after each use, for 21 days
Number of Participants With Ocular Clinical Signs and Discomfort Sensations	0 participants

Adverse Events

Systane

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

Dir Clinical Operations - LACAR, GCRA

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