A Dispensing Clinical Trial of a Study Test Silicone Hydrogel Lens Against Control Lens Over 1 Week
Source: ClinicalTrials.gov NCT02500368 ↗Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comfort |
90; 91; 92; 90; 79; 81 | — |
| PRIMARY Dryness |
94; 94; 94; 92; 75; 78 | — |
| SECONDARY Lens Wettability |
1.09; 1.18; 1.17; 1.38 | — |
| SECONDARY Surface Appearance |
77; 72; 1; 4; 2; 4 | — |
| SECONDARY High Contrast Acuity at High Room Illumination |
-0.10; -0.09; -0.10; -0.08 | — |
| SECONDARY Lens Deposition |
0.06; 0.12; 0.28; 0.38 | — |
| SECONDARY Lens Problems |
0; 2; 0; 1; 0; 1 | — |
| SECONDARY Lens Centration |
43; 51; 1; 1; 12; 6 | — |
| SECONDARY Post-blink Movement |
0.26; 0.25; 0.24; 0.27 | — |
| SECONDARY Lens Tightness |
50.9; 48.1; 48.8; 47.9 | — |
| SECONDARY Visual Quality |
94; 93; 95; 94; 88; 88 | — |
| SECONDARY Ease of Lens Insertion |
97; 92; 91; 90 | — |
| SECONDARY Ease of Lens Removal |
86; 90 | — |
| SECONDARY Overall Lens Fit |
3.35; 3.33; 3.36; 3.38 | — |
| SECONDARY Bulbar Hyperemia |
1.96; 1.96; 1.87; 1.95 | — |
| SECONDARY Limbal Hyperemia |
1.76; 1.76; 1.68; 1.71 | — |
| SECONDARY Corneal Dehydration Staining |
3; 1; 2; 2 | — |
| SECONDARY Corneal Staining (Extent) |
1.21; 1.21; 0.64; 0.75; 4.76; 4.76 | — |
| SECONDARY Conjunctival Indentation |
0.01; 0.01; 0.36; 0.01; 0.00; 0.00 | — |
| SECONDARY Conjunctival Staining |
0.48; 0.48; 0.67; 0.46; 0.47; 0.47 | — |
Eligibility Criteria
Inclusion criteria
-A person is eligible for inclusion in the study if he/she:
- Is at least 17 years of age and has full legal capacity to volunteer
- Has read and understood the information consent letter
- Is willing and able to follow instructions and maintain the appointment schedule
- Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual correction and the assigned study lenses
- Is an adapted soft contact lens wearer (For the purpose of this study: Current lens wear at least 3 days per week, 8 hours each day.)
Exclusion Criteria
-A person will be excluded from the study if he/she:
- Is participating in any concurrent clinical or research study
- Has any known active* ocular disease and/or infection
- Has a systemic condition that in the opinion of the investigator may affect a study outcome variable**
- Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable
- Has known sensitivity to the diagnostic pharmaceuticals to be used in the study
- Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit).
- Is aphakic
- Has undergone corneal refractive surgery.
For the purposes of this study, active* ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active. Participants will be excluded with significant slit lamp findings (e.g. infiltrates or other slit lamp findings Grade 3 or above: corneal edema, tarsal abnormalities, and conjunctival injection) or active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology)
For the purposes of this study, participants will be excluded**, if currently taking medication, such as oral antihistamines, antihistamine eye drops, oral and ophthalmic beta-adrenergic blockers (e.g. Propanolol, Timolol), anticholinergics, oral steroids and any prescribed or over-the-counter eye medication, except artificial tears or eye lubricants
Data sourced from ClinicalTrials.gov (NCT02500368). 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.