Fitting Evaluation of Hydrogel and Silicone Hydrogel Spherical Contact Lenses
NCT ID: NCT03235115
Last Updated: 2019-09-12
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
40 participants
INTERVENTIONAL
2017-06-23
2017-09-22
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.
Clinical Performance of Hydrogel vs. Silicone Hydrogel Contact Lenses
NCT02131402
Fitting Evaluation of Hydrogel and Silicone Hydrogel Sphere Design Contact Lenses
NCT03098745
Non-dispensing Fitting Study Comparing the Clinical Performance Hydrogel Sphere Design Contact Lenses.
NCT02727816
Clinical Evaluation of Two Silicone Hydrogel Contact Lenses
NCT05313412
Clinical Evaluation of Hydrogels vs Silicone Hydrogel Contact Lenses
NCT01966770
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Methafilcon A IV
Subjects are randomized to wear Methafilcon A IV for 1 hour during the cross over study.
Ocufilcon B
Contact Lens
Omafilcon A
Contact Lens
Ocufilcon B
Subjects are randomized to wear Ocufilcon B for 1 hour during the cross over study.
Methafilcon A IV
Contact Lens
Omafilcon A
Contact Lens
Omafilcon A
Subjects are randomized to wear Omafilcon A for 1 hour during the cross over study.
Methafilcon A IV
Contact Lens
Ocufilcon B
Contact Lens
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Methafilcon A IV
Contact Lens
Ocufilcon B
Contact Lens
Omafilcon A
Contact Lens
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
* They are willing and able to follow the protocol.
* They agree not to participate in other clinical research for the duration of this study.
* They have a contact lens spherical prescription between -1.00 to - 6.00D (inclusive)
* They have a spectacle cylindrical correction of -0.75D or less in each eye (based on the ocular refraction).
* They can attain at least 0.10 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.
* They currently use soft contact lenses or have done so in the previous six months.
Exclusion Criteria
* They have a systemic disorder which would normally contra-indicate contact lens wear.
* They are using any topical medication such as eye drops or ointment.
* They have had cataract surgery.
* They have had corneal refractive surgery.
* They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
* They are pregnant or lactating.
* They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
* They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.
* They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
18 Years
40 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
CooperVision, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Eurolens Research - The University of Manchester
Manchester, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EX-MKTG-85
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.