N/A
Completed N=10
Clinical Evaluation of Investigational Multifocal Toric Contact Lenses
Presbyopia · Astigmatism
Source: ClinicalTrials.gov NCT03519282 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
May 2020
Primary outcomePrimary: Visual Acuity — -0.08; -0.06; 0.00; -0.01 logMAR
Summary
This non-dispensing study is to evaluate the clinical performance of a test multifocal toric silicone hydrogel contact lens compared to a marketed multifocal toric contact lens (control).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Acuity |
-0.08; -0.06; 0.00; -0.01; 0.02; 0.01 | — |
| SECONDARY Assessment of Visual Performance: Distance Navigation Tasks for Vision Quality and Clarity |
93; 87 | — |
| SECONDARY Assessment of Visual Performance: Intermediate Task for Vision Quality and Clarity |
95; 95 | — |
| SECONDARY Assessment of Visual Performance: Near Task for Vision Quality and Clarity |
94; 90 | — |
Eligibility Criteria
Inclusion Criteria
- Has had a self-reported oculo-visual examination in the last two years.
- Is aged 40-75 years, inclusive and has full legal capacity to volunteer.
- Has read and understood the participant information sheet.
- Is willing and able to follow instructions and maintain the appointment schedule.
- Is able to participate in Parts A and B related to this work.
- Has a contact lens spherical prescription between +10.00 to -10.00D (inclusive).
- Has an Add component to their spectacle refraction (between +0.75 and +2.50DS).
- Has astigmatism between -0.75 and -5.75DC (based on the vertexed ocular refraction in each eye.
- Can be satisfactorily fitted with the study lenses.
- Is correctable to a visual acuity of 20/40 (0.30 logMAR) or better (in each eye) with their habitual vision correction or 20/25 (0.10 logMAR) best-corrected.
- They have successfully worn soft contact lenses in the last six months
- Has clear corneas and no active ocular disease.
- Has not worn lenses for at least 12 hours before the examination.
- Has an up-to-date pair of spectacles.
Exclusion Criteria
- Has never worn contact lenses before.
- Has any systemic disease affecting ocular health.
- Is using any systemic or topical medications that will affect ocular health.
- Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would, in the opinion of the investigator, affect the wearing of contact lenses.
- Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye that would, in the opinion of the investigator, be problematic for their participation in the study.
- Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
- Is aphakic.
- Has undergone corneal refractive surgery.
- Has a history of anaphylaxis or severe allergic reaction.
- Has diabetes or an infectious or immunosuppressive disease which could contraindicate contact lens wear or pose a risk to the investigator.
- They are pregnant or breast-feeding.
- Is participating in any other type of eye-related clinical or research study.
Data sourced from ClinicalTrials.gov (NCT03519282). 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.