Multi-Centre Clinical Evaluation Of Two Daily Disposable Contact Lenses
This study has been completed.
Sponsor:
Coopervision, Inc.
Information provided by (Responsible Party):
Coopervision, Inc.
ClinicalTrials.gov Identifier:
NCT01707238
First received: September 21, 2012
Last updated: May 17, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The stenfilcon A daily disposable contact lens will provide non-inferior handling compared to etafilcon A daily disposable contact lens.
| Condition | Intervention | Phase |
|---|---|---|
|
Myopia |
Device: etafilcon A; stenfilcon A Device: stenfilcon A; etafilcon A |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) |
Resource links provided by NLM:
Further study details as provided by Coopervision, Inc.:
Primary Outcome Measures:
- Lens handling [ Time Frame: after 2 weeks of lens wear ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | October 2012 |
| Study Completion Date: | March 2013 |
| Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: etafilcon A
etafilcon A
|
Device: etafilcon A; stenfilcon A Device: stenfilcon A; etafilcon A |
|
Experimental: stenfilcon A
stenfilcon A
|
Device: etafilcon A; stenfilcon A Device: stenfilcon A; etafilcon A |
Eligibility| Ages Eligible for Study: | 16 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:-
- Be between 16 and 45 years of age (inclusive)
- Adapted soft 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01707238
Locations
| United Kingdom | |
| Keith Tempany Opticians | |
| Broadstone, Dorset, United Kingdom, MH18 | |
| Cameron-Davies Optometrists | |
| Southsea, Hampshire, United Kingdom, PO5 2AT | |
| Cameron-Davies Optometrists | |
| Portchester, Hants, United Kingdom, PO16 9UN | |
| Leightons Opticians | |
| St. Albans, Hertfordshire, United Kingdom, AL1 3LH | |
| David Gould Opticians | |
| Rawtenstall, Lancashire, United Kingdom, BB4 7QN | |
| Vision Express Optical Lab | |
| Hendon, London, United Kingdom, NW4 3FB | |
| S.H. Harrold | |
| Uxbridge, London, United Kingdom, UB8 1JX | |
Sponsors and Collaborators
Coopervision, Inc.
More Information
No publications provided
| Responsible Party: | Coopervision, Inc. |
| ClinicalTrials.gov Identifier: | NCT01707238 History of Changes |
| Other Study ID Numbers: | EX-MKTG-39 |
| Study First Received: | September 21, 2012 |
| Last Updated: | May 17, 2013 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Additional relevant MeSH terms:
|
Myopia Refractive Errors Eye Diseases |
ClinicalTrials.gov processed this record on May 21, 2013