Dispensing Study to Assess the Visual Performance of Optimised Prototype Contact Lenses
1 other identifier
interventional
161
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2015
CompletedFirst Posted
Study publicly available on registry
June 29, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 7, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 7, 2017
CompletedSeptember 11, 2017
September 1, 2017
1.4 years
June 24, 2015
September 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visual acuity on a LogMAR (logarithm of the minimum angle of resolution) scale
For each lens, visual acuity will be measured at distance with a computerised LogMAR chart and at near with a near LogMAR chart. Data will be summarised as means +/- standard deviations. No transformation is likely to be required. Visual acuity will be compared between each lens design and control lens types. The significance of lens design will be determined for each visit. Repeated effects linear mixed model with subject random intercepts or paired t tests will be employed for the analysis of visual acuity. Analysis will be performed within each study arm namely presbyopes and non-presbyopes.
Approximately 1 week after lens fitting
Secondary Outcomes (1)
Subjective rating of vision on a 1-10 visual analogue scale
Approximately 1 week after lens fitting
Study Arms (2)
Presbyope group
OTHER40 years and over with a reading add. Control lens: Etafilcon A, Nelfilcon A, Nesofilcon A, Somofilcon A, 58% Poly-HEMA Test lens: Etafilcon A Up to 10 prototype contact lens designs and at least 1 commercially available contact lens designs will be worn by each participant for up to a week on a daily disposable modality. Participants will attend separate fitting and assessment visits for each lens type (Fitting Visit on Day 1, and Assessment Visit as late as Day 7, but may be as early as 6 hours after the Fitting Visit). There will be a minimum 1 night washout period between lens designs, i.e. after an assessment visit but before the next fitting visit.
Non-Presbyope group
OTHER18-39 years with no reading add. Control lens: Etafilcon A, Nelfilcon A, Omafilcon A Test lens: Etafilcon A Up to 10 prototype contact lens designs and at least 1 commercially available contact lens designs will be worn by participants for up to a week on a daily disposable modality. Participants will attend separate fitting and assessment visits for each lens type (Fitting Visit on Day 1, and Assessment Visit as late as Day 7, but may be as early as 6 hours after the Fitting Visit). There will be a minimum 1 night washout period between lens designs, i.e. after an assessment visit but before the next fitting visit.
Interventions
Control lens for presbyope group
Control lens for presbyope group
Control lens for presbyope group
Control lens for presbyope group
Control lens for non-presbyope group
Eligibility Criteria
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 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.
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, 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Brien Holden Vision Institute
Sydney, New South Wales, 2052, Australia
Related Publications (2)
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.
PMID: 30907859DERIVEDSha 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.
PMID: 30451806DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer Sha, BOptom/BSc
Brien Holden Vision Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2015
First Posted
June 29, 2015
Study Start
October 1, 2015
Primary Completion
February 7, 2017
Study Completion
February 7, 2017
Last Updated
September 11, 2017
Record last verified: 2017-09