Trial Outcomes & Findings for Multi-Centre Clinical Evaluation Of Two Daily Disposable Contact Lenses (NCT NCT01707238)

NCT ID: NCT01707238

Last Updated: 2020-08-03

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

100 participants

Primary outcome timeframe

two weeks and four weeks from baseline visit

Results posted on

2020-08-03

Participant Flow

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.

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

Participant milestones

Participant milestones
Measure	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.	Etafilcon A Then Stenfilcon A All subjects assigned as overall study population wore both sets of lenses. Study population was randomized to wear either stenfilcon A followed by etafilcon A or etafilcon A followed by stenfilcon A.
Overall Study STARTED	48	52
Overall Study COMPLETED	48	52
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Multi-Centre Clinical Evaluation Of Two Daily Disposable Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stenfilcon A Then Etafilcon A n=48 Participants 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.	Etafilcon A Then Stenfilcon A n=52 Participants 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.	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	6 Participants n=5 Participants	11 Participants n=7 Participants	17 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	42 Participants n=5 Participants	41 Participants n=7 Participants	83 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	38 Participants n=7 Participants	69 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	14 Participants n=7 Participants	31 Participants n=5 Participants
Region of Enrollment United Kingdom	48 participants n=5 Participants	52 participants n=7 Participants	100 participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Stenfilcon A n=100 Participants Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)	Etafilcon A n=100 Participants Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
Handling	8.84 units on a scale Standard Deviation 1.56	6.76 units on a scale Standard Deviation 2.89

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Stenfilcon A n=100 Participants Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)	Etafilcon A n=100 Participants Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
Satisfaction With Handling Completely Satisfied	65 percentage of participants 0.85	28 percentage of participants 1.37
Satisfaction With Handling Somewhat Satisfied	22 percentage of participants	31 percentage of participants
Satisfaction With Handling Neither	8 percentage of participants	13 percentage of participants
Satisfaction With Handling Somwhat Dissatisfied	5 percentage of participants	16 percentage of participants
Satisfaction With Handling Completely Dissatisfied	0 percentage of participants	12 percentage of participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Stenfilcon A n=100 Participants Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)	Etafilcon A n=100 Participants Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
Comfort	8.84 units on a scale Standard Deviation 1.32	8.09 units on a scale Standard Deviation 1.83

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Stenfilcon A n=100 Participants Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)	Etafilcon A n=100 Participants Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
Dryness	8.51 units on a scale Standard Deviation 1.81	8.07 units on a scale Standard Deviation 1.50

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Stenfilcon A n=100 Participants Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)	Etafilcon A n=100 Participants Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
Satisfaction With Dryness Completely Satisfied	58 percentage of participants 0.91	35 percentage of participants 1.00
Satisfaction With Dryness Somewhat Satisfied	30 percentage of participants	43 percentage of participants
Satisfaction With Dryness Neither	5 percentage of participants	8 percentage of participants
Satisfaction With Dryness Somwhat Dissatisfied	6 percentage of participants	14 percentage of participants
Satisfaction With Dryness Completely Dissatisfied	1 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Stenfilcon A n=100 Participants Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)	Etafilcon A n=100 Participants Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
Satisfaction With Comfort Completely Satisfied	65 percentage of participants 0.82	51 percentage of participants 1.09
Satisfaction With Comfort Somewhat Satisfied	27 percentage of participants	26 percentage of participants
Satisfaction With Comfort Neither	3 percentage of participants	13 percentage of participants
Satisfaction With Comfort Somwhat Dissatisfied	4 percentage of participants	7 percentage of participants
Satisfaction With Comfort Completely Dissatisfied	1 percentage of participants	3 percentage of participants

Adverse Events

Stenfilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Etafilcon A

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

Graeme Young

Visioncare Research Ltd.

Phone: 01252 718719

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The investigators will not be permitted to publish or present at scientific meetings results obtained from the clinical study without prior written consent from the sponsor.
Publication restrictions are in place

Restriction type: OTHER