Clinical trial NCT02214797: Dispensing Study to Assess Visual Performance of Prototype Contact Lenses
Official title: Dispensing Study to Assess Visual Performance of Prototype Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Refractive Error
Keywords: Presbyopia
Refractive Error
Contact Lenses
Lead sponsor: Brien Holden Vision
Sponsor class: INDUSTRY
First posted: 2014-08-12
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study is to assess visual performance of prototype soft contact lens designs compared to commercially available contact lenses over one-week of lens wear.

Detailed description: Prospective, participant-masked, multiple arm, crossover dispensing clinical trial where participants will wear prototype (test) and commercial (control) lenses bilaterally. Participants will be stratified based on their refractive error into either presbyopic or non-presbyopic group. Each of the stratified group will have a maximum of 4 parallel arms. Up to 4 test lens designs will be assessed against the control/s in each parallel arm in a randomized cross over fashion, with a minimum 2 day washout period between the lens types. Each lens assessment will require 2 scheduled clinic attendances - a fitting visit and an evaluation visit.

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 18 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 in each eye with contact lenses
* Be willing to not wear contact lenses for a minimum of 2 days before each stage of the clinical trial (after informed consent)

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 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
* Eye surgery within 12 weeks immediately prior to enrolment for this trial.
* Previous corneal refractive surgery
* Contraindications to contact lens wear
* Known allergy or intolerance to ingredients in any of the clinical trial products

The Investigator may, at his/her discretion, exclude anyone who they believe may not be able to fulfil the clinical trial requirements or it is believed to be in the participant's best interests

Primary outcomes:
measure: Change in visual performance over 1-week lens wear
timeFrame: after about 20 minutes of lens wear and after about 1 week of lens wear
Secondary outcomes:
measure: Change in subjective response over 1-week of lens wear
timeFrame: After about 40 mins of lens wear and after 2 days, 4 days and 1 week of lens wear
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Brien Holden Vision Institue, Clinical Research Trials Center
state: New South Wales
Study officials:
affiliation: Brien Holden Vision Institute
name: Jiyoon Chung, BOptom
role: PRINCIPAL_INVESTIGATOR
References:
citation: Young G, Veys J, Pritchard N, Coleman S. A multi-centre study of lapsed contact lens wearers. Ophthalmic Physiol Opt. 2002 Nov;22(6):516-27. doi: 10.1046/j.1475-1313.2002.00066.x.
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: Jong M, Tilia D, Sha J, Diec J, Thomas V, Bakaraju RC. The Relationship between Visual Acuity, Subjective Vision, and Willingness to Purchase Simultaneous-image Contact Lenses. Optom Vis Sci. 2019 Apr;96(4):283-290. doi: 10.1097/OPX.0000000000001359.