Multi-Centre Clinical Evaluation Of Two Daily Disposable Contact Lenses

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01707238

Enrollment

100

Registered

2012-10-16

Start date

2012-10-31

Completion date

2013-03-31

Last updated

2020-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

Brief summary

The purpose of this study is to compare the subjective performance for handling of two daily disposable contact lenses, stenfilcon A and etafilcon A.

Detailed description

The study is to compare the subjective performance for handling of two daily disposable contact lenses, stenfilcon A and etafilcon A in this cross-over study.

Interventions

DEVICEetafilcon A

Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.

DEVICEstenfilcon A

Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

16 Years to 45 Years

Healthy volunteers

Inclusion criteria

- * Be between 16 and 45 years of age (inclusive) * Adapted soft contact lens (CL) wearers (i.e. \> 1 month) * Spherical distance CL prescription between -1.00 and -6.00D (inclusive) * Spectacle cylinder ≤0.75D in the least astigmatic eye, ≤1.00D in the other. * Correctable to 6/9 (20/30) in both eyes * Have the use of a mobile phone to send and receive text messages throughout the day for the duration of the study. * Have read, understood and signed the informed consent * Willing to comply with the wear schedule (at least 40 hours per week) * Willing to comply with the study visit schedule

Exclusion criteria

- * Any active corneal infection, injury or inflammation * Systemic or ocular allergies, which might interfere with CL wear * Systemic disease, which might interfere with CL wear * Ocular disease, which might interfere with CL wear * Strabismus, amblyopia * Subjects who have undergone corneal refractive surgery and any anterior segment surgery * Subjects with keratoconus or other severe corneal irregularity contraindicating lens wear * Pregnant or lactating * Use of systemic/topical medication contraindicating CL wear * Use of gas permeable contact lenses within the last month * Employees of the investigational site or immediate family members of Investigators * Participation in any concurrent clinical trial or in the last 30 days

Design outcomes

Primary

Measure	Time frame	Description
Handling	two weeks and four weeks from baseline visit	Participant's subjective rating for lens handling of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (0-10, 10= very easy).
Satisfaction With Handling	two weeks and four weeks from baseline visit	Participant's subjective rating for overall satisfaction of lens handling of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (5 point Likert scale - Completely Dissatisfied, Somewhat Dissatisfied, Neither, Somewhat Satisfied, Completely Satisfied).

Secondary

Measure	Time frame	Description
Comfort	two weeks and four weeks from baseline visit	Participant's subjective rating for overall lens comfort of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (0-10, 10=can't feel).
Dryness	two weeks and four weeks from baseline visit	Participant's subjective rating for overall lens dryness of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (0-10, 10=no dryness).
Satisfaction With Dryness	two weeks and four weeks from baseline visit	Participant's subjective rating for overall satisfaction of lens dryness of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (5 point Likert scale - Completely Dissatisfied, Somewhat Dissatisfied, Neither, Somewhat Satisfied, Completely Satisfied).
Satisfaction With Comfort	two weeks and four weeks from baseline visit	Participant's subjective rating for overall satisfaction of lens comfort of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (5 point Likert scale - Completely Dissatisfied, Somewhat Dissatisfied, Neither, Somewhat Satisfied, Completely Satisfied).

Countries

United Kingdom

Participant flow

Recruitment details

Number subjects enrolled per site ranged six to 25. Two sites were asked to enroll more than 20 subjects to fulfill required number of subjects. Approval from Ethics Committee sought before sites were invited to recruit additional subjects. Of the 100 enrolled, 13 were existing etafilcon A wearers, falling short of the 25% target.

Pre-assignment details

All participants randomized to receive all interventions and combined into one Arm/Group, Overall All Study Population for the participant flow.

Participants by arm

Arm	Count
Stenfilcon A Then Etafilcon A All subjects assigned as overall study population wore both sets of lenses. Overall study population was randomized to wear either stenfilcon A followed by etafilcon A or etafilcon A followed by stenfilcon A.	48
Etafilcon A Then Stenfilcon A All subjects assigned as overall study population wore both sets of lenses. Overall study population was randomized to wear either stenfilcon A followed by etafilcon A or etafilcon A followed by stenfilcon A.	52
Total	100

Baseline characteristics

Characteristic	Stenfilcon A Then Etafilcon A	Etafilcon A Then Stenfilcon A	Total
Age, Categorical <=18 years	6 Participants	11 Participants	17 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	42 Participants	41 Participants	83 Participants
Region of Enrollment United Kingdom	48 participants	52 participants	100 participants
Sex: Female, Male Female	31 Participants	38 Participants	69 Participants
Sex: Female, Male Male	17 Participants	14 Participants	31 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 100	0 / 100
other Total, other adverse events	0 / 100	0 / 100
serious Total, serious adverse events	0 / 100	0 / 100

Outcome results

Primary

Handling

Participant's subjective rating for lens handling of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (0-10, 10= very easy).