N/A Completed N=24 Randomized Single-blind Treatment

A Clinical Comparison of 2 Multifocal Toric XR (Extended Range) Contact Lenses

Astigmatism

Source: ClinicalTrials.gov NCT03006458 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2020

Primary outcomePrimary: Stability — 3.2; 2.9 units on a scale

Summary

This study aims to compare the clinical performance and subjective acceptance of the comfilcon A and the omafilcon B soft contact lenses.

Outcome Measures

Outcome	Result	p-value
PRIMARY Stability	3.2; 2.5	—
PRIMARY Overall Toric Lens Fit Acceptance	3.5; 2.8	—
PRIMARY Comfort	79.8; 70.6	—
PRIMARY Overall Satisfaction	63.0; 63.3	—
PRIMARY Dryness	80.4; 77.2	—
PRIMARY Visual Fluctuation/ Stability	81.0; 73.8	—
PRIMARY Handling	84.5; 85.8	—
PRIMARY Quality of Near Vision	38.5; 56.4	—
PRIMARY Quality of Intermediate Vision	50.2; 65.3	—
PRIMARY Quality of Distance Vision	86.2; 67.3	—
PRIMARY Quality of Vision While Driving During the Day	87.3; 76.2	—
PRIMARY Quality of Vision While Driving During the Night	78.0; 67.0	—
PRIMARY Ghosting at Near	66.5; 78.1	—
PRIMARY Ghosting at Distance	83.3; 86.9	—

Eligibility Criteria

Inclusion Criteria

Subjects will only be eligible for the study if:
They are aged 40 - 70 years, inclusive.
They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
They are willing and able to follow the protocol.
They have successfully completed the non-dispensing study (C16-597) as the lenses to be worn on this study (C16-599) are predetermined from their participation on study C16-597.
They have a contact lens spherical prescription between +10.00 to -10.00D (Diopters) (inclusive).
They have astigmatism between of -0.75 and -5.75DC (based on the calculated ocular refraction) in each eye.
They have an Add component to their spectacle refraction (between +0.75 and

+2.50DS).

They can be satisfactorily fitted with the study lenses.
They can attain at least 0.30 logMAR binocular distance high contrast visual acuity with the study lenses within the available power range.
They have successfully worn soft contact lenses in the last two years.
They are willing to comply with the wear schedule (at least five days per week and for at least six hours per day).
They agree not to participate in other clinical research for the duration of this study.
They own a wearable pair of spectacles.

Exclusion Criteria

Subjects will not be eligible to take part in the study if:
They have an ocular disorder which would normally contra-indicate contact lens wear.
They have a systemic disorder which would normally contra-indicate contact lens wear.
They are using any topical medication such as eye drops or ointment.
They have had cataract surgery.
They have had corneal refractive surgery.
They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
They are pregnant or breast-feeding.
They have any clinically meaningful slit lamp findings contraindicating contact lens wear (e.g. ≥ Grade 3 finding of oedema, corneal neovascularisation, corneal staining, tarsal abnormalities, conjunctival injection, blepharitis/meibomian gland dysfunction) on the Efron classification scale or any other ocular abnormality that in the opinion of the investigator would contraindicate contact lens wear.
They have any infectious disease (e.g. hepatitis) which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV).
They have a history of anaphylaxis or severe allergic reaction.
They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03006458). 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.