Astigmatism Clinical Trial
Official title:
Performance of Toric Silicone Hydrogel Contact Lenses Following Two Weeks of Daily Wear
Verified date | November 2019 |
Source | Coopervision, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Prospective study to evaluate the clinical performance of fanfilcon A toric contact lens and senofilcon A toric contact lens after two weeks of wear.
Status | Completed |
Enrollment | 45 |
Est. completion date | October 8, 2018 |
Est. primary completion date | October 8, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - 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 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 -2.25 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: - 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 -2.50 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. - 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. |
Country | Name | City | State |
---|---|---|---|
Mexico | Optometry Clinic, National Autonomous University | Mexico City |
Lead Sponsor | Collaborator |
---|---|
Coopervision, Inc. |
Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lens Centration | Centration of lens on eye (Optimum, Decentration acceptable, Decentration unacceptable) | Baseline | |
Primary | Lens Centration | Centration of lens on eye (Optimum, Decentration acceptable, Decentration unacceptable) | 2 weeks | |
Primary | Corneal Coverage | Lens covering the cornea (Yes, No) | Baseline | |
Primary | Corneal Coverage | Lens covering the cornea (Yes, No) | 2 weeks | |
Primary | Post Blink Movement | Amount of lens movement after blink (0-5 Likert Scale, 0=Insufficient, 2=Optimal, 4=Excessive movement) | Baseline | |
Primary | Post Blink Movement | Amount of lens movement after blink (0-5 Likert Scale, 0=Insufficient, 2=Optimal, 4=Excessive movement) | 2 weeks | |
Secondary | Wearing Time | Average daily wearing time (hours/day) | 2 weeks | |
Secondary | Comfortable Wearing Time | Comfortable daily wearing time (hours/day) | 2 weeks |
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