Clinical trial NCT02484586: Dispensing Study to Assess the Visual Performance of Optimised Prototype Contact Lenses
Official title: Dispensing Study to Assess the Visual Performance of Optimised Prototype Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Refractive Error
Keywords: Presbyopia
Refractive error
Contact lens
Lead sponsor: Brien Holden Vision
Sponsor class: INDUSTRY
First posted: 2015-06-29
Enrollment: 161
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 the visual performance of multiple optimised prototype soft contact lens designs compared to commercially available contact lenses.

Detailed description: Prospective, double-masked, crossover, bilateral wear, dispensing clinical trial where participants will wear multiple prototype (test) and commercial (control) lenses.

Multiple prototype contact lens designs will be assessed against commercial control lenses during the study, where each design will be worn for up to a week. There will be a minimum 1 night washout period between lens designs.

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.
* Is correctable to at least 6/12 (20/40) or better in each eye 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, Sjogrens 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. Ocular medication can be prescribed during the course of the trial as per standard optometric practice.
* 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. Note: 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.

Primary outcomes:
measure: Visual acuity on a LogMAR (logarithm of the minimum angle of resolution) scale
timeFrame: Approximately 1 week after lens fitting
Secondary outcomes:
measure: Subjective rating of vision on a 1-10 visual analogue scale
timeFrame: Approximately 1 week after lens fitting
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Brien Holden Vision Institute
state: New South Wales
Study officials:
affiliation: Brien Holden Vision Institute
name: Jennifer Sha, BOptom/BSc
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Sha J, Tilia D, Kho D, Amrizal H, Diec J, Yeotikar N, Jong M, Thomas V, Bakaraju RC. Visual Performance of Daily-disposable Multifocal Soft Contact Lenses: A Randomized, Double-blind Clinical Trial. Optom Vis Sci. 2018 Dec;95(12):1096-1104. doi: 10.1097/OPX.0000000000001311.