Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Visual Performance of Prototype Contact Lens Designs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02193555
Recruitment Status : Completed
First Posted : July 17, 2014
Last Update Posted : November 6, 2014
Sponsor:
Information provided by (Responsible Party):
Brien Holden Vision

Brief Summary:
The aim of this study is to assess the visual performance of prototype soft contact lens designs compared to a commercially available contact lens

Condition or disease Intervention/treatment Phase
Presbyopia Refractive Error Device: Etafilcon A, Senofilcon A Not Applicable

Detailed Description:
Prospective, participant-masked, randomised, stratified, crossover, bilateral wear, dispensing clinical trial where participants will wear the prototype (test) and the commercial (control) lens. A minimum of an overnight washout period is required between the fitting /assessment visits.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Official Title: Visual Performance of Prototype Contact Lens Designs
Study Start Date : July 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Non-presbyopic group

Non-presbyopic group: age ranging from 7 to 39 years

At each scheduled lens fitting visit, subjects will be allocated one pair of CLs to correct their refractive error. One pair of control (Acuvue 1- Day Moist, etafilcon A) or prototype (Iteration X, etafilcon A) CLs will be allocated for each lens fitting/assessment visit. Lenses will be worn for approximately 1 hour per visit.

For each fitting visit, lenses will be fitted bilaterally.

Device: Etafilcon A, Senofilcon A
1 pair of either test or control lenses will be fitted on the subject for up to 1 hour of lens wear per visit (total of 2 fitting visits).
Other Names:
  • Control lenses
  • Non-presbyopic group
  • Brand name: 1-Day Acuvue® Moist®
  • Lens material: Etafilcon A
  • Presbyopic group
  • Brand name: Acuvue® Oasys® for Presbyopia
  • Lens material: Senofilcon A
  • Test lens
  • Brand name: Iteration X

Presbyopic group

Presbyopic group: age 40 and above

At each scheduled lens fitting visit, subjects will be allocated one pair of CLs to correct their refractive error. One pair of control (Acuvue Oasys for Presbyopia, senofilcon A) or prototype (Iteration X, etafilcon A) CLs will be allocated for each lens fitting/assessment visit. Lenses will be worn for approximately 1 hour per visit.

For each fitting visit, lenses will be fitted bilaterally.

Device: Etafilcon A, Senofilcon A
1 pair of either test or control lenses will be fitted on the subject for up to 1 hour of lens wear per visit (total of 2 fitting visits).
Other Names:
  • Control lenses
  • Non-presbyopic group
  • Brand name: 1-Day Acuvue® Moist®
  • Lens material: Etafilcon A
  • Presbyopic group
  • Brand name: Acuvue® Oasys® for Presbyopia
  • Lens material: Senofilcon A
  • Test lens
  • Brand name: Iteration X




Primary Outcome Measures :
  1. Visual performance [ Time Frame: After about 20 minutes of lens wear ]
    Visual acuity


Secondary Outcome Measures :
  1. Subjective responses [ Time Frame: After about 40 minutes of lens wear ]
    Subjective ratings of vision



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   7 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
  • Be at least 7 years old, male or female.
  • Willing to comply with the wearing and clinical trial visit schedule as directed by the Investigator.
  • Have ocular health findings considered to be "normal" and which would not prevent the participant from safely wearing contact lenses.
  • Correctable to at least 6/12 (20/40) or better with both eyes with contact lenses.
  • Be suitable and willing to wear contact lenses.

Exclusion Criteria:

  • Any pre-existing ocular irritation, injury or condition (including infection or disease) of the cornea, conjunctiva or eyelids that would preclude contact lens fitting and safe wearing of contact lenses.
  • Any systemic disease that adversely affects ocular health e.g. diabetes, Graves' disease, and auto immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants.
  • Use of or a need for concurrent category S3 and above ocular medication at enrolment and/or during the clinical trial.
  • Use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participant's ocular health / physiology or contact lens performance either in an adverse or beneficial manner at enrolment and/or during the clinical trial.
  • Eye surgery within 12 weeks immediately prior to enrolment for this trial.

NB: Systemic antihistamines are allowed on an "as needed basis", provided they are not used prophylactically during the trial and at least 24 hours before the clinical trial product is used.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02193555


Locations
Layout table for location information
Australia, New South Wales
Brien Holden Vision Institute, Clinical Research Trials Center
Sydney, New South Wales, Australia, 2052
Sponsors and Collaborators
Brien Holden Vision
Investigators
Layout table for investigator information
Principal Investigator: Jiyoon Chung, BOptom Brien Holden Vision Institute