Clinical trial NCT01765972: Open Eye Corneal Swelling With Daily Disposable Contact Lenses and no Lens Wear
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Corneal Swelling
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2013-01-11
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary purpose of this clinical trial is to evaluate the eye's response to three test soft contact lenses as well as no lens wear, with respect to Corneal Staining.


Eligibility criteria: Inclusion Criteria:

1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
2. The subject must appear able and willing to adhere to the instructions set forth in the clinical protocol.
3. The subject must be between 18 and 45 years of age.
4. The subject must be an adapted soft contact lens wearer in both eyes.
5. The subject must be of East or Southeast Asian descent, e.g. ethnic Chinese, Japanese, Korean, Malay, Vietnamese, Indonesian, Filipino, etc. (it is preferred but not required that both the subject's biological parents are East or Southeast Asian ethnicity, by self report).
6. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 to -6.00 D in each eye.
7. The subject's refractive cylinder must be no more than 1.00D in each eye.
8. The subject must have best corrected visual acuity of +0.14 logMAR (equivalent to 20/25-2) or better in each eye.
9. Subjects must own a wearable pair of spectacles and wear them on the day of the initial visit, during the washout before each phase and during the no lens wear phase.
10. The subject must have normal eyes (i.e., no ocular medications or infections of any type).

Exclusion Criteria:

1. Are currently pregnant or lactating by self report (subjects who become pregnant during the study will be discontinued).
2. Have any ocular or systemic allergies or diseases that may interfere with contact lens wear.
3. Have any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but may not be limited to, diabetes. hyperthyroidism, recurrent herpes simplex/zoster, Sjogren's syndromes, xerophthalmia, acne rosacea, Stevens-Johnson syndromes, HIV/AIDS, hepatitis, and tuberculosis.
4. Use of any topical medications such aas eye drops or ointments.
5. Have entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosion, or aphakia.
6. Had any previous, or planned ocular or intraocular surgery (e.g. cataract surgery, radial keratotomy, PRK, LASIK, etc.).
7. Have any grade 2.0 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the Efron classification scale or any other ocular abnormality that may contraindicate contact lens wear.
8. Have any known hypersensitivity or allergic reaction to one of the study products.
9. Have any ocular infection.
10. Have any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
11. Have participated in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
12. Have any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV by self report).
13. Currently wear their contact lenses on an extended wear basis.
14. Are an employee of the investigational clinic (e.g. Investigator, Coordinator, Technician)

Primary outcomes:
measure: Percentage Change From Baseline of Corneal Swelling 8 Hours Post Fit
timeFrame: 8 hours post fit
Secondary outcomes:
Other outcomes:
Locations:
city: Waterloo
country: Canada
state: Ontario
Study officials:
References: