Visual Performance of Prototype Contact Lens Designs

NCT02193555 | Completed

• 1 other identifier: CRTC2014-02
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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

Conditions

Presbyopia; Refractive Error

Keywords

Presbyopia; Refractive error correction; Contact lenses

Outcome Measures

Primary Outcomes (1)

• Visual performance

  Visual acuity

  After about 20 minutes of lens wear

Secondary Outcomes (1)

• Subjective responses

  After about 40 minutes of lens wear

Study Arms (2)

Non-presbyopic group

OTHER

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

Presbyopic group

OTHER

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

Interventions

Etafilcon A, Senofilcon A DEVICE

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).

Also known as: 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

Non-presbyopic group; Presbyopic group

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brien Holden Vision: lead

Study Sites (1)

Brien Holden Vision Institute, Clinical Research Trials Center

Sydney, New South Wales, 2052, Australia

Location

Related Publications (4)

• Morgan PB, Efron N. A decade of contact lens prescribing trends in the United Kingdom (1996-2005). Cont Lens Anterior Eye. 2006 May;29(2):59-68. doi: 10.1016/j.clae.2006.02.008. Epub 2006 Mar 31.

  PMID: 16580247 BACKGROUND

• Stapleton F, Keay L, Edwards K, Naduvilath T, Dart JK, Brian G, Holden BA. The incidence of contact lens-related microbial keratitis in Australia. Ophthalmology. 2008 Oct;115(10):1655-62. doi: 10.1016/j.ophtha.2008.04.002. Epub 2008 Jun 5.

  PMID: 18538404 BACKGROUND

• Anstice NS, Phillips JR. Effect of dual-focus soft contact lens wear on axial myopia progression in children. Ophthalmology. 2011 Jun;118(6):1152-61. doi: 10.1016/j.ophtha.2010.10.035. Epub 2011 Jan 26.

  PMID: 21276616 BACKGROUND

• Sankaridurg P, Holden B, Smith E 3rd, Naduvilath T, Chen X, de la Jara PL, Martinez A, Kwan J, Ho A, Frick K, Ge J. Decrease in rate of myopia progression with a contact lens designed to reduce relative peripheral hyperopia: one-year results. Invest Ophthalmol Vis Sci. 2011 Dec 9;52(13):9362-7. doi: 10.1167/iovs.11-7260.

  PMID: 22039230 BACKGROUND

MeSH Terms

Conditions

Presbyopia; Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Jiyoon Chung, BOptom

  Brien Holden Vision Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2014
• First Posted: July 17, 2014
• Study Start: July 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: November 1, 2014
• Last Updated: November 6, 2014

Record last verified: 2014-07

Locations

AU (1)