Dispensing Study to Assess the Visual Performance of Optimised Prototype Contact Lenses
NCT ID: NCT02484586
Last Updated: 2017-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
161 participants
INTERVENTIONAL
2015-10-31
2017-02-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Dispensing Study to Assess Visual Performance of Prototype Contact Lenses
NCT02214797
Visual Performance of Prototype Contact Lens Designs
NCT02193555
Evaluation of Investigational Daily Disposable Multifocal Contact Lenses Produced With Different Manufacturing Processes in Myopes
NCT04889625
Performance Assessment of a Modified Daily Disposable Contact Lens
NCT03762668
Asian Clinical Evaluation of an Investigational Contact Lens for Cosmetic Effect
NCT01446835
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Presbyope group
40 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.
Etafilcon A
Prototype lens material
Etafilcon A
Control lens for presbyope group
Nelfilcon A
Control lens for presbyope group
Nesofilcon A
Control lens for presbyope group
Somofilcon A
Control lens for presbyope group
58% Poly-HEMA
Control lens for presbyope group
Non-Presbyope group
18-39 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.
Etafilcon A
Prototype lens material
Nelfilcon A
Control lens for non-presbyope group
Etafilcon A
Control lens for non-presbyope group
Omafilcon A
Control lens for non-presbyope group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Etafilcon A
Prototype lens material
Etafilcon A
Control lens for presbyope group
Nelfilcon A
Control lens for presbyope group
Nesofilcon A
Control lens for presbyope group
Nelfilcon A
Control lens for non-presbyope group
Etafilcon A
Control lens for non-presbyope group
Somofilcon A
Control lens for presbyope group
58% Poly-HEMA
Control lens for presbyope group
Omafilcon A
Control lens for non-presbyope group
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
18 Years
70 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Brien Holden Vision
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jennifer Sha, BOptom/BSc
Role: PRINCIPAL_INVESTIGATOR
Brien Holden Vision Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Brien Holden Vision Institute
Sydney, New South Wales, Australia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CRTC2014-04
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.