Multi-Centre Clinical Evaluation Of Two Daily Disposable Contact Lenses

NCT01707238 | Completed Results DMC

• 1 other identifier: EX-MKTG-39
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 7

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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Comfort

  two weeks and four weeks from baseline visit

• Dryness

  two weeks and four weeks from baseline visit

• Satisfaction With Dryness

  two weeks and four weeks from baseline visit

• Satisfaction With Comfort

  two weeks and four weeks from baseline visit

Study Arms (2)

stenfilcon A

EXPERIMENTAL

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

Device: etafilcon A

etafilcon A

ACTIVE COMPARATOR

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

Device: stenfilcon A

Interventions

etafilcon A DEVICE

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

Also known as: etafilcon A (Daily Disposable Contact Lens)

stenfilcon A

stenfilcon A DEVICE

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

Also known as: stenfilcon A (Daily Disposable Contact Lens)

etafilcon A

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (7)

Keith Tempany Opticians

Broadstone, Dorset, MH18, United Kingdom

Location

Cameron-Davies Optometrists

Southsea, Hampshire, PO5 2AT, United Kingdom

Location

Cameron-Davies Optometrists

Portchester, Hants, PO16 9UN, United Kingdom

Location

Leightons Opticians

St Albans, Hertfordshire, AL1 3LH, United Kingdom

Location

David Gould Opticians

Rawtenstall, Lancashire, BB4 7QN, United Kingdom

Location

Vision Express Optical Lab

Hendon, London, NW4 3FB, United Kingdom

Location

S.H. Harrold

Uxbridge, London, UB8 1JX, United Kingdom

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Graeme Young
• Organization: Visioncare Research Ltd.

g.young@visioncare.co.uk

01252 718719

Study Officials

• Graeme Young

  Visioncare Research Ltd.

  STUDY DIRECTOR

• Ruth Craven

  Visioncare Research Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2012
• First Posted: October 16, 2012
• Study Start: October 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: March 1, 2013
• Last Updated: August 3, 2020
• Results First Posted: August 27, 2014

Record last verified: 2020-07

Locations

GB (7)