Clinical trial NCT02193555: Visual Performance of Prototype Contact Lens Designs
Official title: Visual Performance of Prototype Contact Lens Designs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Refractive Error
Keywords: Presbyopia
Refractive error correction
Contact lenses
Lead sponsor: Brien Holden Vision
Sponsor class: INDUSTRY
First posted: 2014-07-17
Enrollment: 91
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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

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.

Eligibility 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.

Primary outcomes:
measure: Visual performance
timeFrame: After about 20 minutes of lens wear
Secondary outcomes:
measure: Subjective responses
timeFrame: After about 40 minutes of lens wear
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Brien Holden Vision Institute, Clinical Research Trials Center
state: New South Wales
Study officials:
affiliation: Brien Holden Vision Institute
name: Jiyoon Chung, BOptom
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.