Clinical trial NCT01875471: Clinical Evaluation of Two Daily Disposable Contact Lenses
Official title: Clinical Evaluation of Two Daily Disposable Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Error
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2013-06-11
Enrollment: 279
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The objective of this study is to compare the ease of removing two daily disposable soft contact lenses off the eye.


Eligibility criteria: Inclusion Criteria:

1. The subject must be between 18 and 45 years of age (inclusive)with no presbyopic add.
2. 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).
3. The subject must be willing to wear the study lenses for at least 8 hours per day, at least 6 days between visits.
4. The subject must be a current successful spherical soft contact lens wearer in both eyes.
5. The subject must appear willing and able to adhere to the instructions set forth in this clinical protocol.
6. 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.
7. The subject's refractive astigmatism must be less than or equal to -0.75D in both eyes.
8. The subject must have corrective visual acuity of 6/9 (20/30) or better in each eye.
9. The subject must require a visual correction in both eyes (no monofit or monovision allowed).

Exclusion Criteria:

1. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
2. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
3. 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.
4. Clinically significant (Grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
5. Any ocular infection.
6. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
7. Currently pregnant or lactating (subject who become pregnant during the study will be discontinued).
8. Diabetes.
9. Infectious diseases (e.g. hepatitis, tuberculosis) or an immunosuppressive disease (e.g. HIV).
10. Amblyopia
11. Evidence of lid abnormality or infection (including blepharitis/meibomitis)
12. Conjunctival abnormality or infection.
13. Any active ocular disease.
14. Employee or family member of the staff of the investigational site.

Primary outcomes:
measure: Subjective Ease of Lens Removal
timeFrame: Day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Knowle
country: United Kingdom
state: Bristol
city: Portchester
country: United Kingdom
state: Hampshire
city: Hay-on-Wye
country: United Kingdom
state: Herefordshire
city: St. Albans
country: United Kingdom
state: Herts
city: Eastcote, Pinner
country: United Kingdom
state: Middlesex
city: Cardiff
country: United Kingdom
state: South Glamorgan
city: Farnham
country: United Kingdom
state: Surrey
city: Brighton
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: Norwich
country: United Kingdom
Study officials:
References: