Open Eye Corneal Swelling With Daily Disposable Contact Lenses and no Lens Wear

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT01765972
First received: January 8, 2013
Last updated: August 21, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Corneal Swelling
Device: etafilcon A with print
Device: etafilcon A with print w Lacreon
Device: etafilcon A with Lacreon
Device: No Contact Lenses

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by Vistakon:

Primary Outcome Measures:
  • Corneal Swelling [ Time Frame: 7 hours post fit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Endothelial bleb response [ Time Frame: 20 minutes post fit ] [ Designated as safety issue: No ]
  • Corneal Swelling [ Time Frame: 7 hours post fit ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: December 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: etafilcon A with print
Lenses to be worn in a daily wear modality
Device: etafilcon A with print Device: etafilcon A with print w Lacreon Device: etafilcon A with Lacreon Device: No Contact Lenses
Active Comparator: etafilcon A with print w Lacreon
Lenses to be worn in a daily wear modality
Device: etafilcon A with print Device: etafilcon A with print w Lacreon Device: etafilcon A with Lacreon Device: No Contact Lenses
Active Comparator: etafilcon A with Lacreon
Lenses to be worn in a daily wear modality
Device: etafilcon A with print Device: etafilcon A with print w Lacreon Device: etafilcon A with Lacreon Device: No Contact Lenses
Placebo Comparator: No Contact Lenses
Lenes to be worn as instructed by investigator
Device: etafilcon A with print Device: etafilcon A with print w Lacreon Device: etafilcon A with Lacreon Device: No Contact Lenses

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01765972

Locations
Canada, Ontario
Waterloo, Ontario, Canada
Sponsors and Collaborators
Vistakon
  More Information

No publications provided

Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT01765972     History of Changes
Other Study ID Numbers: CR-5252
Study First Received: January 8, 2013
Last Updated: August 21, 2013
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Edema
Signs and Symptoms

ClinicalTrials.gov processed this record on August 18, 2014