N/A
Completed N=88
Evaluation of Silicone Hydrogel Daily Wear Contact Lenses for Up to One (1) Month of Daily Wear
Source: ClinicalTrials.gov NCT03722784 ↗Enrolled (actual)
88
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcomePrimary: Number of Eyes With Epithelial Edema - Slit Lamp Findings — 112; 56; 0; 0 Eyes
Summary
The aim of the study is to evaluate if the performance of Invigor A is substantially equivalent to Invigor B contact lenses when used in a one month recommended replacement, daily wear modality.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Eyes With Epithelial Edema - Slit Lamp Findings |
110; 54; 0; 0; 0; 0 | — |
| PRIMARY Number of Eyes With Epithelial Edema - Slit Lamp Findings |
110; 54; 0; 0; 0; 0 | — |
| PRIMARY Number of Eyes With Stromal Edema - Slit Lamp Findings |
110; 54; 0; 0; 0; 0 | — |
| PRIMARY Number of Eyes With Stromal Edema - Slit Lamp Findings |
110; 54; 0; 0; 0; 0 | — |
| PRIMARY Number of Eyes With Corneal Vascularization - Slit Lamp Findings |
98; 54; 12; 0; 0; 0 | — |
| PRIMARY Number of Eyes With Corneal Vascularization - Slit Lamp Findings |
98; 54; 12; 0; 0; 0 | — |
| PRIMARY Number of Eyes With Corneal Staining - Slit Lamp Findings |
20; 9; 90; 45 | — |
| PRIMARY Number of Eyes With Corneal Staining - Slit Lamp Findings |
20; 9; 90; 45 | — |
| PRIMARY Number of Eyes With Corneal Infiltrates - Slit Lamp Findings |
0; 0; 110; 54 | — |
| PRIMARY Number of Eyes With Corneal Infiltrates - Slit Lamp Findings |
0; 0; 110; 54 | — |
| PRIMARY Number of Eyes With Limbal Hyperemia - Slit Lamp Findings |
110; 52; 0; 2; 0; 0 | — |
| PRIMARY Number of Eyes With Limbal Hyperemia - Slit Lamp Findings |
110; 52; 0; 2; 0; 0 | — |
| PRIMARY Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings |
90; 46; 20; 8; 0; 0 | — |
| PRIMARY Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings |
90; 46; 20; 8; 0; 0 | — |
| PRIMARY Number of Eyes With Palpebral Conjunctival Observations - Slit Lamp Findings |
36; 20; 76; 36 | — |
| PRIMARY Number of Eyes With Palpebral Conjunctiva - Slit Lamp Findings |
42; 12; 68; 42 | — |
| PRIMARY Number of Eyes With Other Findings - Conjunctival Infection, Epidemic Keratoconjunctivitis, Corneal Ulcers, Iritis, Lens Adhesions and Recurrent Erosion - Slit Lamp Findings |
106; 52; 4; 2; 0; 0 | — |
| PRIMARY Number of Eyes With Other Findings - Conjunctival Infection, Epidemic Keratoconjunctivitis, Corneal Ulcers, Iritis, Lens Adhesions and Recurrent Erosion - Slit Lamp Findings |
106; 52; 4; 2; 0; 0 | — |
| SECONDARY Number of Eyes With Visual Acuity for an Effective Visual Distance of 20 Feet |
92; 45; 7; 4; 11; 5 | — |
Eligibility Criteria
- Inclusion Criteria:
- Be at least 18 years of age as of the date of evaluation for the study
- Have
- Read the informed consent document
- Been given an explanation of the informed consent document
- indicated understanding of the informed consent document
- Signed the informed consent document
- Be willing and able to adhere to the instructions provided by the investigational site and be willing to keep all specified appointments.
- Be an adapted, frequent replacement, current full - time silicone hydrogel or soft contact lens wearer. An adapted full- time wearer is defined as wearing contact lenses at least 5 days per week for at least 8 hours per day for at least one month prior to participation in the study.
- Possess or obtain prior to dispensing, wearable and visually functional (20/40 or better) eyeglasses.
- Be in good general health, based on his/her knowledge.
- Exclusion Criteria:
- Wearing lenses in a monovision modality and is unwilling to be fit with distance lenses in both eyes for the duration of the study. Note: Subjects may not wear lenses in a monovision modality at any time during the study as it will interfere with the visual acuity analysis.
- Poor personal hygiene.
- Any active participation in another clinical trial during this trial or within 30 days prior to this study.
- To the best of the subject's knowledge, she is currently pregnant, is lactating or is planning a pregnancy within the next 3 months.
- A member, relative or household member of the investigator(s) or of the investigational office staff.
- A known sensitivity to the ingredients used in the multi-purpose solution approved for use in the study and is unable or unwilling to use the alternate care system.
- Had previous refractive surgery; or current or previous orthokeratology treatment.
- Aphakic or pseudophakic.
- Ocular or systemic disease such as, but not limited to: anterior uveitis or iritis (past or present), glaucoma, Sjögren's syndrome, lupus erythematosus, scleroderma, keratoconus or uncontrolled diabetes.
- The need for topical ocular medications or any systemic medication which might interfere with contact lens wear or require the lenses to be removed during the day.
- A known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates, iritis, bacterial or fungal infections.
- A history of papillary conjunctivitis that has interfered with contact lens wear.
Data sourced from ClinicalTrials.gov (NCT03722784). 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. Informational only — not medical advice.