Multi-Centre Clinical Evaluation Of Two Daily Disposable Contact Lenses

Myopia Clinical Trial

Official title:

Multi-Centre Clinical Evaluation Of Two Daily Disposable Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01707238
• Other study ID #: EX-MKTG-39
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Est. completion date: March 2013

Study information

• Verified date: July 2020
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• etafilcon 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.
• stenfilcon 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.

Locations

Country	Name	City	State
United Kingdom	Keith Tempany Opticians	Broadstone	Dorset
United Kingdom	Vision Express Optical Lab	Hendon	London
United Kingdom	Cameron-Davies Optometrists	Portchester	Hants
United Kingdom	David Gould Opticians	Rawtenstall	Lancashire
United Kingdom	Cameron-Davies Optometrists	Southsea	Hampshire
United Kingdom	Leightons Opticians	St. Albans	Hertfordshire
United Kingdom	S.H. Harrold	Uxbridge	London

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	two weeks and four weeks from baseline visit
Primary	Satisfaction With Handling	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).	two weeks and four weeks from baseline visit
Secondary	Comfort	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).	two weeks and four weeks from baseline visit
Secondary	Dryness	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).	two weeks and four weeks from baseline visit
Secondary	Satisfaction With Dryness	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).	two weeks and four weeks from baseline visit
Secondary	Satisfaction With Comfort	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).	two weeks and four weeks from baseline visit