NCT02356692CompletedNot Applicable
Clinical Comfort Evaluation of Two Marketed Spherical Contact Lenses
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Coopervision, Inc.
- Enrollment
- 60
- Locations
- 6
- Primary Endpoint
- Comfort at Insertion
Study Overview
Brief Summary
The purpose of this study was to investigate the overall clinical comfort performance of enfilcon A (test) lens and senofilcon A (control) lens over 15-minutes of lens wear.
Detailed Description
This was a non-dispensing, single-masked, randomized, contralateral study comparing Enfilcon A (test) against Senofilcon A (control). Each subject was randomized to wear the test lens in one eye and the control lens in the other eye.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 38 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Based on his/her knowledge, must be in good general health.
- •Be 18 to 38 years old.
- •Be able and willing to adhere to the instructions set forth in this protocol and complete all specified evaluation.
- •Read, indicate understanding of, and sign Written Informed Consent.
- •Be existing or successfully adapted users of soft contact lenses, but not currently wearing either of the study lenses (Avaira or Oasys) being evaluated in this trial.
- •Require a visual correction in both eyes.
- •Require a prescription between +8.00D and -12.00D and have less than or equal to 0.75D of astigmatism in both eyes.
- •Achieve visual acuity of 20/25 or better in each eye with a spherical contact lens prescription.
- •Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
- •No amblyopia.
- •No evidence of lid abnormality or infection (e.g. entropion, ectropion, chalazia, recurrent styes).
- •lamp findings Grade 2 or above: corneal edema, tarsal abnormalities, and conjunctival injection).
- •No other active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, cornea [infiltrates], conjunctiva, lids, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology).
- •No aphakia.
Exclusion Criteria
- •0.75D or greater of refractive astigmatism in either eye.
- •Presbyopic or current monovision contact lens wear.
- •Cannot be currently wearing either lenses (Avaira or Oasys).
- •Presence of clinically significant (grade 2-4) anterior segment abnormalities; inflammation such as iritis; or any infection of the eye, lids, or associated structures.
- •Presence of ocular or systemic disease or need of medication 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 the limbus
- •Giant papillary conjunctivitis (GPC) worse than Grade 1
- •Anterior uveitis or iritis (past or present)
- •Seborrheic eczema, seborrheic conjunctivitis
- •History of corneal ulcer or fungal infections
- •Poor personal hygiene
- •A known history of corneal hypoesthesia (reduced corneal sensitivity)
- •Contact Lens best corrected Snellen visual acuities (VA) worse than 20/
- •Aphakia, Keratoconus or a highly irregular cornea.
Outcomes
Primary Outcomes
Comfort at Insertion
Time Frame: 15 minutes
Participant's response for comfort at 15 minutes. (Scale 0-10; 0=poor/intolerable, 10=comfortable/ cannot be felt) Obtained at 15 minutes.
Comfort Preference
Time Frame: 15 minutes
Participant's response for comfort of enfilcon A (test) lens, senofilcon A (control) lens at 15 minutes wear.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (6)
Loading locations...
Similar Trials
Completed
Phase 4
Comparing Patient Comfort and Safety Between Iodixanol and Iopamidol in Patients Undergoing Peripheral ArteriographyDrug SafetyNCT01475097GE Healthcare255
Completed
Phase 4
Iodixanol Versus Iopamidol in Patients Undergoing Contrast-Enhanced Computed Tomographic Imaging of Abdomen/PelvisPatient Comfort and SafetyNCT01376089GE Healthcare304
Completed
Not Applicable
Evaluation of Comfilcon A and Senofilcon A LensesMyopiaNCT01695369Coopervision, Inc.61
Unknown
Not Applicable
Comparison of Patient Perceived Pain and Satisfaction Between Lightweight and Heavyweight Mesh for Laparoscopic Inguinal Hernia RepairInguinal HerniaNCT01638221Ascension Health200
Completed
Not Applicable
Pain Perception With a Comfort-ın Jet Injection and Conventional Dental InjectionPainLocal InfiltrationAnesthesiaFearNeedle PhobiaAnxietyNCT04682080Tokat Gaziosmanpasa University94