Assessment of Comfort & Ocular Surface Parameters w Novel Designs of Daily Disposable Silicone Hydrogel Contact Lenses (BASS)

Menicon

Status: Completed

Conditions: Visual Acuity; Contact Lens Comfort

Treatments: Device: Menicon Modified Lens Design

Study type: Interventional

Funder types: Industry

Identifiers

NCT03454542

P/626/17/M

Details and patient eligibility

About

A comparison of two lens designs manufactured in the same material. The hypothesis is the subjectively rated performance of comfort, vision and lens handling will be better with the modified design compared to the initial design

Full description

The objectives of the study are

1. to identify possible reasons for the different comfort and vision experience in Japanese CL wearers compared to Caucasian CL wearers and
2. to assess whether the modification of lens thickness in the optical zone results in increased comfort and reduced visual acuity fluctuations in Caucasian eyes.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Is at least 18 years of age and has full legal capacity to volunteer;

2. Has read and signed an information consent letter;

3. Is willing and able to follow instructions and maintain the appointment schedule;

4. Is of Caucasian heritage;

5. Habitually wears soft spherical daily disposable contact lenses with a power between

   -0.50 to -2.75D (inclusive);

6. Demonstrates an acceptable fit with both study CL designs (initial & modified);

7. Is correctable to a visual acuity of 0.20 LogMAR (approximately 20/30) or better (in each eye) with both study CL designs;

8. Has a manifest cylindrical spectacle refraction that does not exceed -1.00DC in either eye;

9. Should own a wearable pair of spectacles. -

Exclusion criteria

1. Is participating in any concurrent clinical or research study;
2. Has any known active* ocular disease and/or infection;
3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
5. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
6. Is pregnant, lactating or planning a pregnancy at the time of enrolment (by self-report);
7. Is aphakic;
8. Has undergone refractive error surgery; -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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16 participants in 2 patient groups

Menicon DSRB Redesign

Experimental group

Description:

Menicon DSRB Modified Lens Design is a single use contact lens with revised thickness specifications worn for 6 hours or more.

Treatment:

Device: Menicon Modified Lens Design

Menicon DSRB Original Design

Active Comparator group

Description:

Menicon DSRB Initial Lens Design is a single use contact lens with the original thickness specifications worn for 6 hours or more.

Treatment:

Device: Menicon Modified Lens Design