Clinical trial NCT02081677: One Month Daily Wear Clinical Evaluation of New Prototype Contact Lenses in Habitual and Neophyte Contact Lens Wearers
Official title: One Month Daily Wear Clinical Evaluation of Three Prototype Soft Contact Lenses in a Population of Habitual and Neophyte Contact Lens Wearers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Correction
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2014-03-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There will be four study lenses tested; one marketed lens, and three prototype study lenses. Subjects will be randomized to one of the four study lenses which will be worn in a daily wear modality, with a two week replacement.


Eligibility criteria: Inclusion Criteria:

1. The subject must be between 18 and 39 years of age.
2. The subject must be able to read and understand English.
3. The subject read, understand, and sign the Statement of Informed Consent and receive a fully executed copy of the form.
4. The subject must not have been a participant in a contact lens or contact lens solution study/investigation in the previous seven days.
5. The subject must be willing to wearthe study lenses for at least 6 hours per day, 7 days per week (e.g. does not regularly swim).
6. The subject must appear able and willing and able to the adhere to the instructions set forth in this clinical protocol.
7. The subject's subjective refraction must result in a vertex corrected spherical contact lens prescription in the range of -1.00D to -4.00D in each eye.
8. The subject's refractive astigamatism must be less than or equal to -1.00D in both eyes.
9. The subjet must have best corrected visual acuity of 20/30 (6/9 or +0.20 logMAR) or better in each eye.
10. The subject must require a visual correction in both eyes (no monofit or monovision allowed).
11. The subject must have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:

    * No amblyopia
    * No evidence of lid abnormality or infection (including blepharitis/meibomitis)
    * No conjunctival abnormality or infection.
    * No clinically significant slit lamp findings (i.e. stromal edema, vascularization, corneal scaring, infiltrates or abnormal opacities).
    * No other active ocular diseases.

Exclusion Criteria:

1. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
2. Any systemic diseases, autoimmune disease, or use of medication, which may interfere with contact lens wear.
3. Clinically significant (Grade 3 or 4) corneal edeam, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
4. Any ocular infection.
5. Any corneal distortion resulting from previous hard or rigid permeable contact lens wear.
6. Pregnancy or lactation (subjects who become pregnant during the study will be discontinued).
7. No extended wear in the last 3 months.
8. Diabetes.
9. Infectious diseases (e.g. hepatitis, tuberculosis) or immunosuppressive disease (e.g. HIV).
10. Has had refractive surgery.
11. Employee of VRF with direct involvement in the study or a family member of the clinic.

Primary outcomes:
measure: Corneal Staining (Area)
timeFrame: Baseline and 4-Week Follow-up
measure: Corneal Staining (Depth)
timeFrame: Baseline and 4-Week Follow-up
measure: Corneal Staining (Type)
timeFrame: Baseline and 4-Week Follow-up
measure: Limbal Conjunctival Redness
timeFrame: Baseline and 2-Week Follow-up
measure: Bulbar Conjunctival Redness
timeFrame: Baseline and 2-Week Follow-up
measure: Visual Acuity (LogMAR)
timeFrame: 4-Week Follow-up
measure: Lens Fitting Characteristics
timeFrame: Post Lens Fitting and 4-Week Follow-up
measure: Percentage of Reported Ocular Symptoms (Burning/Stinging)
timeFrame: Baseline and 4-Week Follow-up
measure: Corneal Edema
timeFrame: Baseline and 4-Week Follow-up
measure: Conjunctival Injection
timeFrame: Baseline and 4-Week Follow-up
measure: Corneal Neovascularization
timeFrame: Baseline and 4-Week Follow-up
measure: Corneal Staining
timeFrame: Baseline and 4-Week Follow-up
measure: Tarsal Abnormalities
timeFrame: 1-, 2- and 4-Week Follow-up
measure: Percentage of Reported Ocular Symptoms (Cloudy/Blurry/Hazy)
timeFrame: Baseline and 4-Week Follow-up
measure: Percentage of Reported Ocular Symptoms (Dryness)
timeFrame: Baseline and 4-Week Follow-up
measure: Percentage of Reported Ocular Symptoms (Grittiness/Foreign Body Sensation)
timeFrame: Baseline and 4-Week Follow-up
measure: Percentage of Reported Ocular Symptoms (Irritation/Discomfort)
timeFrame: Baseline and 4-Week Follow-up
measure: Percentage of Reported Ocular Symptoms (Itchiness/Scratchiness)
timeFrame: Baseline and 4-Week Follow-up
measure: Percentage of Reported Ocular Symptoms (Lens Awareness)
timeFrame: Baseline and 4-Week Follow-up
measure: Percentage of Reported Ocular Symptoms (Redness)
timeFrame: Baseline and 4-Week Follow-up
measure: Percentage of Reported Ocular Symptoms (Variable Vision)
timeFrame: Baseline and 4-Week Follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Chennai
country: India
state: Tamil Nadu
Study officials:
References: