Astigmatism Clinical Trial
Official title:
Clinical Performance of Toric Hydrogel Contact Lenses Following One Week of Daily Wear
Verified date | December 2016 |
Source | Coopervision, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Mexico: Ethics Committee |
Study type | Interventional |
The aim of this prospective study is to evaluate the clinical performance of filcon IV1 toric and ocufilcon D toric contact lenses after 1 week of wear in each pair.
Status | Completed |
Enrollment | 30 |
Est. completion date | December 2016 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 40 Years |
Eligibility |
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. |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Mexico | Optometry Clinic, National Autonomous University | Mexico D.F. |
Lead Sponsor | Collaborator |
---|---|
Coopervision, Inc. |
Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall fit acceptance | Investigator's preference for lens fit acceptance for filcon IV1 and ocufilcon D. Scale 0-4, 0=should not be worn, 1=borderline but unacceptable, 2= minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect | Up to 1 week | No |
Primary | Lens centration | Lens centration for filcon IV1 and ocufilcon D. (Centered - optimal, decentered slightly, or substantially decentered). | Up to 1 week | No |
Primary | Post-blink movement | Post-blink movement for filcon IV1 and ocufilcon D. Scale 0-4, 0=insufficient, 1=minimal, but acceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement. | Up to 1 week | No |
Primary | Overall stability | Overall lens stability for falcon IV1 and ocufilcon D. Scale 0-4, 0=very poor, 4=excellent | Up to 1 week | No |
Primary | Corneal coverage | Corneal coverage for filcon IV1 and ocufilcon D. (yes or no) | Up to 1 week | No |
Primary | Lens orientation in primary position of gaze | Lens orientation in primary position of gaze for filcon IV1 and ocufilcon D by slit lamp. | Up to 1 week | No |
Primary | Rotational recovery in degrees after 60 seconds | Rotational recovery in degrees after 60 seconds for filcon IV1 and ocufilcon D by slit lamp. | Up to 1 week | No |
Status | Clinical Trial | Phase | |
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