A Clinical Study of Systane® Lid Wipes in Brazil

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02380261
• Collaborator: NOVARTIS BIOCIENCIAS S/A (Other)
• Enrollment: 35
• Location: 1
• Arm: 1
• Duration (Days): 30
• Patients Per Site Per Month: 35.5

Study Details

Study Description

Brief Summary

The purpose of this study is to verify the skin and ocular tolerance of the product Systane® Lid Wipes.

Condition or Disease	Intervention/Treatment	Phase
Ocular Tolerance; Skin Tolerance	Other: Systane® Lid Wipes	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Official Title: Assessment Of The Skin And Ocular Tolerance Of The Product Systane® Lid Wipes (050343-01) And Assessment Of The Study Subject Acceptance, Under Normal Use Conditions
• Study Start Date: Sep 1, 2015
• Actual Primary Completion Date: Oct 1, 2015
• Actual Study Completion Date: Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Systane Systane® Lid Wipes, 1 per eyelid, used once and discarded after each use, for 21 days	Other: Systane® Lid Wipes; Commercially-marketed, individually-packaged, pre-moistened eyelid wipe for daily cleaning

Outcome Measures

Primary Outcome Measures

1. Number of Participants With a Contact-dermatitis Adverse Reaction [Day 21]

   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.

2. Number of Participants With Ocular Clinical Signs and Discomfort Sensations [Day 21]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Must sign informed consent.

• Agree to adhere to the procedures and requirements of the study.

• Wears makeup daily.

• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Pregnant or breastfeeding.

• Ocular conditions as specified in protocol.

• Medical conditions as specified in protocol.

• Skin conditions as specified in protocol.

• Other protocol-specified exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Biociencias SA	Sao Paulo		Brazil	04636-000

Sponsors and Collaborators

• Alcon Research
• NOVARTIS BIOCIENCIAS S/A

Investigators

• Study Director: Medical Director, Alcon Brazil

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT02380261
• Other Study ID Numbers: EXR338-P001
• First Posted: Mar 5, 2015
• Last Update Posted: Nov 18, 2016
• Last Verified: Aug 1, 2016

Study Results

Participant Flow

Recruitment Details	Participants were recruited from 1 study center located in Brazil.
Pre-assignment Detail	Thirty-five participants were enrolled in this study. This reporting group includes all enrolled participants (35).

Arm/Group Title	Systane
Arm/Group Description	Systane® Lid Wipes, 1 per eyelid, used once and discarded after each use, for 21 days
Period Title: Overall Study
STARTED	35
COMPLETED	35
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Systane
Arm/Group Description	Systane® Lid Wipes, 1 per eyelid, used once and discarded after each use, for 21 days
Overall Participants	35
Age, Customized (participants) [Number]
Age 18-70	35 100%
Sex: Female, Male (Count of Participants)
Female	35 100%
Male	0 0%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With a Contact-dermatitis Adverse Reaction
Description	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.
Time Frame	Day 21

Outcome Measure Data

Analysis Population Description

This analysis population includes all enrolled participants.

Arm/Group Title	Systane
Arm/Group Description	Systane® Lid Wipes, 1 per eyelid, used once and discarded after each use, for 21 days
Measure Participants	35
Number [participants]	0 0%

2. Primary Outcome

Title	Number of Participants With Ocular Clinical Signs and Discomfort Sensations
Description	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.
Time Frame	Day 21

Outcome Measure Data

Analysis Population Description

This analysis population includes all enrolled participants.

Arm/Group Title	Systane
Arm/Group Description	Systane® Lid Wipes, 1 per eyelid, used once and discarded after each use, for 21 days
Measure Participants	35
Number [participants]	0 0%

Adverse Events

Time Frame	Adverse events (AEs) were collected for the duration of participation in the study (up to 21 days). This analysis group includes all enrolled participants. Ocular AEs are presented for both study eye and non-study eye combined.
Adverse Event Reporting Description	An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a product and that does not necessarily have a causal relationship with this treatment. All AEs were obtained as solicited and spontaneous comments from the study participants and through regular investigator assessment throughout the study.
Arm/Group Title	Systane
Arm/Group Description	Systane® Lid Wipes, 1 per eyelid, used once and discarded after each use, for 21 days
All Cause Mortality
	Systane
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Systane
	Affected / at Risk (%)	# Events
Total	0/35 (0%)
Other (Not Including Serious) Adverse Events
	Systane
	Affected / at Risk (%)	# Events
Total	0/35 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Sponsor reserves the right of prior review of any publication or presentation of information related to the study.