N/A
N=120
Clinical Comfort Evaluation of Two Marketed Spherical Contact Lenses
Astigmatism
Bottom Line
View on ClinicalTrials.gov: NCT02356692 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Comfort at Insertion — 8.7; 8.5 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- enfilcon A (Device); senofilcon A (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- CooperVision, Inc.
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comfort at Insertion |
8.1; 8.7 | — |
| PRIMARY Comfort at Insertion |
8.1; 8.7 | — |
| PRIMARY Comfort Preference |
25; 35 | — |
| PRIMARY Comfort Preference |
25; 35 | — |
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.
Eligibility Criteria
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 20/30.
- Aphakia, Keratoconus or a highly irregular cornea.
Data sourced from ClinicalTrials.gov (NCT02356692). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.