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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02847169 |
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Date of registration:
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25/07/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Clinical Performance of Toric Hydrogel Contact Lenses Following One Week of Daily Wear
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Scientific title:
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Clinical Performance of Toric Hydrogel Contact Lenses Following One Week of Daily Wear |
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Date of first enrolment:
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September 2016 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02847169 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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N/A
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Countries of recruitment
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Mexico
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Contacts
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Name:
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Velázquez Guerrero, MSc., FIACLE |
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Address:
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Telephone:
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Email:
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Affiliation:
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School of Optometry, National Autonomous University (UNAM) |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- A person is eligible for inclusion in the study if he/she:
- Is between 18 and 40 years of age (inclusive)
- Has had a self-reported visual exam in the last two years
- Is an adapted soft toric contact lens wearer
- Has a contact lens spherical prescription between +6.00 to - 9.00 (inclusive)
- Have no less than -0.75D of astigmatism and no more than -2.00 D in both eyes.
- Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10
logMAR) or better in each eye.
- Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye
with the study contact lenses.
- Has clear corneas and no active ocular disease
- Has read, understood and signed the information consent letter.
- Patient contact lens refraction should fit within the available parameters of the
study lenses.
- Is willing to comply with the wear schedule (at least 5 days per week, > 8
hours/day assuming there are no contraindications for doing so).
- Is willing to comply with the visit schedule
Exclusion Criteria:
- A person will be excluded from the study if he/she:
- Has a CL prescription outside the range of the available parameters of the study
lenses.
- Has a spectacle cylinder less than -0.75D or more than -2.00 D of cylinder in
either eye.
- Has a history of not achieving comfortable CL wear (5 days per week; > 8
hours/day)
- Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in
either eye.
- Presence of clinically significant (grade 2-4) anterior segment abnormalities
- Presence of ocular or systemic disease or need of medications which might
interfere with contact lens wear. Confidential EX-MKTG-66 Clinical Performance of
Toric Hydrogel Contact Lenses Following One Week of Daily Wear 10
- Slit lamp findings that would contraindicate contact lens wear such as:
- Pathological dry eye or associated findings
- Pterygium, pinguecula, or corneal scars within the visual axis
- Neovascularization > 0.75 mm in from of the limbus
- Giant papillary conjunctivitis (GCP) worse than grade 1
- Anterior uveitis or iritis (past or present)
- Seborrheic eczema, Seborrheic conjunctivitis
- History of corneal ulcers or fungal infections
- Poor personal hygiene
- Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
- Has aphakia, keratoconus or a highly irregular cornea.
- Has Presbyopia or has dependence on spectacles for near work over the contact
lenses.
- Has undergone corneal refractive surgery.
- Is participating in any other type of eye related clinical or research study.
Age minimum:
18 Years
Age maximum:
40 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Astigmatism
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Intervention(s)
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Device: filcon IV1 toric lens
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Device: ocufilcon D toric lens
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Primary Outcome(s)
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Lens Centration
[Time Frame: Baseline and 1 week]
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Rotational Recovery in Degrees After 60 Seconds
[Time Frame: Baseline and 1 week]
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Lens Orientation in Primary Position of Gaze
[Time Frame: Baseline and 1 week]
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Post-blink Movement
[Time Frame: Baseline and 1 week]
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Corneal Coverage
[Time Frame: Baseline and 1 week]
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Overall Fit Acceptance
[Time Frame: Baseline and 1 week]
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Overall Stability
[Time Frame: Baseline and 1 week]
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Secondary ID(s)
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EX-MKTG-66
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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