Clinical Evaluation of Two Daily Disposable Contact Lenses
1 other identifier
interventional
279
1 country
11
Brief Summary
The objective of this study is to compare the ease of removing two daily disposable soft contact lenses off the eye.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2013
Shorter than P25 for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 7, 2013
CompletedFirst Posted
Study publicly available on registry
June 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedResults Posted
Study results publicly available
June 4, 2015
CompletedJune 19, 2018
May 1, 2016
2 months
June 7, 2013
May 6, 2015
June 18, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Subjective Ease of Lens Removal
After 1-week of lens wear, each subject was asked to rate a question, 'Ease of taking the lenses off of your eyes', using 5-point scale (1=Excellent, 2=Very Good, 3=Good, 4=Fair, 5=Poor).
Day 7
Study Arms (2)
delefilcon A
ACTIVE COMPARATORSpherical daily disposable soft contact lens
narafilcon A
EXPERIMENTALSpherical daily disposable soft contact lens Class 1 UV blocking
Interventions
Daily disposable soft contact lens to be worn at least 8 hours daily
Daily disposable contact lens to be worn at least 8 hours daily
Eligibility Criteria
You may qualify if:
- The subject must be between 18 and 45 years of age (inclusive)with no presbyopic add.
- The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. This should be recorded on the Case Report Form (CRF).
- The subject must be willing to wear the study lenses for at least 8 hours per day, at least 6 days between visits.
- The subject must be a current successful spherical soft contact lens wearer in both eyes.
- The subject must appear willing and able to adhere to the instructions set forth in this clinical protocol.
- The subject's subjective refraction must result in a vertex corrected spherical contact lens prescription in the range of -1.00D to -6.00D (inclusive) in each eye.
- The subject's refractive astigmatism must be less than or equal to -0.75D in both eyes.
- The subject must have corrective visual acuity of 6/9 (20/30) or better in each eye.
- The subject must require a visual correction in both eyes (no monofit or monovision allowed).
You may not qualify if:
- Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
- Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
- Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or infiltrates or any other abnormalities of the cornea which would contraindicate contact lens wear.
- Clinically significant (Grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
- Any ocular infection.
- Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
- Currently pregnant or lactating (subject who become pregnant during the study will be discontinued).
- Diabetes.
- Infectious diseases (e.g. hepatitis, tuberculosis) or an immunosuppressive disease (e.g. HIV).
- Amblyopia
- Evidence of lid abnormality or infection (including blepharitis/meibomitis)
- Conjunctival abnormality or infection.
- Any active ocular disease.
- Employee or family member of the staff of the investigational site.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Unknown Facility
Knowle, Bristol, BS4 2AL, United Kingdom
Unknown Facility
Portchester, Hampshire, PO16 9UN, United Kingdom
Unknown Facility
Hay-on-wye, Herefordshire, HR3 5EQ, United Kingdom
Unknown Facility
St Albans, Herts, AL1 3LH, United Kingdom
Unknown Facility
Eastcote, Pinner, Middlesex, HA5 1RJ, United Kingdom
Unknown Facility
Cardiff, South Glamorgan, CF24 3RQ, United Kingdom
Unknown Facility
Farnham, Surrey, GU9 7EN, United Kingdom
Unknown Facility
Brighton, BN1 1RH, United Kingdom
Unknown Facility
London, N2 8AG, United Kingdom
Unknown Facility
London, NW4 3FB, United Kingdom
Unknown Facility
Norwich, NR2 1PB, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Daria Wicks
- Organization
- Johnson & Johnson Vision Care
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2013
First Posted
June 11, 2013
Study Start
June 1, 2013
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
June 19, 2018
Results First Posted
June 4, 2015
Record last verified: 2016-05