Toric Eye Strain and Stability Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Vistakon
Sponsor:
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT01857102
First received: May 8, 2013
Last updated: September 5, 2013
Last verified: September 2013
  Purpose

The purpose of this study is to determine the benefits of fitting low astigmats with soft toric contact lenses versus spherical contact lenses with regard to visual comfort, eyestrain, fitting efficiency, and visual performance.


Condition Intervention
Astigmatism
Device: Etafilcon A
Device: Etafilcon A Astigmatism

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Vistakon:

Primary Outcome Measures:
  • Objective Comfort [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Measured by electromyography


Secondary Outcome Measures:
  • Monocular high contrast visual performance on LogMAR scale [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Monocular low contrast visual performance on LogMAR scale [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Monocular over refraction visual performance on LogMAR scale [ Time Frame: 1 Week ] [ Designated as safety issue: No ]
  • Monocular spherical aberration [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Assessed by aberrometry

  • Subjective assessment of visual comfort, eyestrain, fatigue [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Participants will respond to a sponsor provided questionnaire

  • Lens Fitting Efficiency and Timing [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    Number of lens trials needed to determine an acceptable fit.


Estimated Enrollment: 96
Study Start Date: September 2013
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Etafilcon A Device: Etafilcon A
Soft contact lens to be worn in a daily wear modality for one week
Device: Etafilcon A Astigmatism
Soft contact lens to be worn by participants in a daily wear modality for one week.
Experimental: Etafilcon A Astigmatism Device: Etafilcon A
Soft contact lens to be worn in a daily wear modality for one week
Device: Etafilcon A Astigmatism
Soft contact lens to be worn by participants in a daily wear modality for one week.

  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 have read, understand, and sign the statement of informed consent and receive a fully executed copy of the Informed Consent Form.
  2. The subject must appear able and willing to adhere to the instructions set forth in this protocol.
  3. The subject must be between 18 years and 45 years of age (inclusive).
  4. The subject must have best-corrected Snellen visual acuity of 20/30 or better in each eye.
  5. If the subject has ever worn contact lenses, the subject must be a current wearer of soft spherical contact lenses for at least 5 days/week and at least 8 hours/day during the month prior to enrollment.
  6. Subjective refraction must result in a vertex-corrected astigmatic contact lens prescription requiring at least -0.75 DC but not more than -1.75 DC cylindrical contact lens correction in each eye.
  7. Subjective refraction must result in a vertex-corrected spherical contact lens prescription between +0.25D to +4.00D or between-0.50D to -9.00D in each eye.
  8. The subject must not have the need for presbyopic correction (i.e., they must not be using as add in spectacles or wearing multifocal or monofocal contact lenses).
  9. The subject must have normal eyes with no evidence of abnormality or disease that in the opinion of the investigator would contraindicate contact lens wear.
  10. The subject must have access to the internet throughout the day (either desktop and/or smartphone) and be willing to answer a web-based survey within 1 hour of receiving a text message based notification throughout the day for up to 8 days, throughout the study duration.

Exclusion Criteria:

  1. Self-reported current pregnancy or lactation or plans to become pregnant during the study period (subjects who report becoming pregnant during the study will be discontinued)
  2. Any previous ocular or intra-ocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.)
  3. Any clinically meaningful slit lamp findings contraindicating contact lens wear (e.g. greater than or equal to grade 3 finding of edema, corneal neovascularization, corneal staining, conjunctival injection, blepharitis/meibomian gland dysfunction) on the FDA classification scale or any other ocular abnormality that in the opinion of the investigator may contraindicate contact lens wear.
  4. Any ocular infection
  5. Current use of topical ophthalmic medications other than artificial tears/rewetting drops.
  6. History of binocular vision abnormality or strabismus.
  7. Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV) by self-report.
  8. Other active ocular disease that in the opinion of the investigator would contraindicate contact lens wear.
  9. Employee of the investigational clinic (e.g. investigator, coordinator, technician)
  10. Subject does not have a wearable pair of spectacles.
  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: NCT01857102

Contacts
Contact: Tina Chen 1-713-743-2809

Locations
United States, Texas
Recruiting
Houston, Texas, United States, 77204
Sponsors and Collaborators
Vistakon
  More Information

No publications provided

Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT01857102     History of Changes
Other Study ID Numbers: CR-5363
Study First Received: May 8, 2013
Last Updated: September 5, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Astigmatism
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on August 28, 2014