N/A Completed N=30 Randomized Single-blind Treatment

A Clinical Assessment of the Hemacopolymer Daily Disposable Limbal Ring Soft Contact Lens

Myopia

Source: ClinicalTrials.gov NCT01965262 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2016

Primary outcomePrimary: Visual Acuity - Hema-copolymer and Etafilcon A — -0.08; -0.04; 0.17; 0.20 logMAR

Summary

This purpose of this study is to compare the clinical performance and subjective acceptance of two different daily disposable limbal ring lenses.

Outcome Measures

Outcome	Result	p-value
PRIMARY Visual Acuity - Hema-copolymer and Etafilcon A	-0.08; -0.04; 0.18; 0.23	—
PRIMARY Biomicroscopy - Hema-copolymer and Etafilcon A	0.96; 0.96; 0.86; 0.79; 0.10; 0.11	—
PRIMARY Lens Surface - Deposition - Hema-copolymer and Etafilcon A	26; 14; 3; 6; 0; 0	—
PRIMARY Lens Surface - Debris - Hema-copolymer and Etafilcon A	29; 18; 0; 2; 0; 0	—
PRIMARY Lens Surface - Wettability - Hema-copolymer and Etafilcon A	19; 13; 6; 6; 4; 1	—
PRIMARY Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A	0; 0; 2; 0; 11; 13	—
PRIMARY Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A	0; 0; 35; 11; 16; 17	—
PRIMARY Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A	0; 0; 3; 0; 53; 40	—
PRIMARY Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A	0; 0; 5; 2; 33; 28	—
PRIMARY Comfort Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A	80.8; 76.0; 69.1; 66.6; 75.8; 69.5	—
PRIMARY Vision Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A	85.6; 71.6; 83.3; 65.0; 83.1; 67.4	—
PRIMARY Peripheral Blur (Subjective Assessment) - Hema-copolymer and Etafilcon A	80.2; 76.4	—
PRIMARY Ocular Redness (Subjective Assessment) - Hema-copolymer and Etafilcon A	87.2; 89.0	—
PRIMARY Handling (Subjective Assessment) - Hema-copolymer and Etafilcon A	92.0; 77.5; 95.2; 90.5	—
PRIMARY Attractiveness (Subjective Assessment) - Hema-copolymer and Etafilcon A	66.7; 68.0	—
PRIMARY Overall Impression (Subjective Assessment) - Hema-copolymer and Etafilcon A	75.0; 63.9	—

Eligibility Criteria

Inclusion Criteria

Subjects will only be eligible for the study if:

They are 18 years of age and above.
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 agree not to participate in other clinical research for the duration of this study.
They can attain at least 6/9 in each eye with the study lenses within the available power range.
They can be fitted with study lenses within the available power range.
The currently use soft contact lenses, or have done so within the last six months.

Exclusion Criteria

Subjects will not be able to take part in the study if:

They have an ocular disorder which would normally contraindicate contact lens wear.
They have a systemic disorder which would normally contraindicate 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 lactating.
They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
They have any infectious disease which would normally contraindicate contact lens wear, or may, in the opinion of the investigator, pose a risk to study personnel; or any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reactions.
They have taken part in any other clinical trial or research, within two weeks prior to starting this study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01965262). 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.