Comparison of Clinical Performance and Subjective Preference of Three Contact Lenses

Myopia Clinical Trial

Official title:

Comparison of Clinical Performance and Subjective Preference Out of Three Cosmetic Contact Lenses (Limbal Ring-enhancing Lenses, LRE Lenses)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03134599
• Other study ID #: CV_BSCHU
• Status: Completed
• Phase: N/A
• Start date: May 23, 2017
• Est. completion date: June 24, 2017

Study information

• Verified date: December 2019
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the clinical performance and subject's preference out of three LRE (Limbal Ring Enhancing) lens types: etafilcon A (Johnson&Johnson), methafilcon A (Interozzo), and methafilcon A (CooperVision).

Description:

This will be a subject-masked, bilateral, randomized, crossover dispensing study to compare clinical performance and subjective preference out of three lens types. Sixty subjects will be assigned into three groups and each group will wear the test and control lenses as matched pairs for one week in random order. Lenses will be worn on a daily wear, daily disposable schedule.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 24, 2017
• Est. primary completion date: June 24, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age of 18 years and above and has full legal capacity as a volunteer Understand the rights as a research subject and willing and able sign a statement of informed consent

• Existing soft contact lens wearers or previous experience of contact lens wear

• Being able to wear the study lenses for at least eight hours a day

• At least 6/9 visual acuity in each eye with the study lenses

• Astigmatism less than 1.50 D (Diopter) in both eyes

• Agreed to follow the protocol and not to participate in other clinical research for the duration of this study

Exclusion Criteria:

• Have an ocular disorder which would normally contraindicate contact lens wear

• Have a systemic disorder or any infectious diseases which would normally contraindicate contact lens wear

• Have previously had any ocular surgery such as corneal refractive surgery

• Have less than 6/9 visual acuity in each eye with the study lenses

• Are currently using any topical medication such as eye drops or ointment

• Have any corneal distortion resulting from previous rigid lens wear or have keratoconus

• Are currently pregnant or lactating

• No previous contact lens wear

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• etafilcon A
contact lens
• methafilcon A - Interozzo
contact lens
• methafilcon A - CVI (CooperVision)
contact lens

Locations

Country	Name	City	State
Korea, Republic of	School of Optometry & Vision Science, Catholic University of Daegu, Korea (Rep)	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comfort	Subjective ratings of comfort for each lens pair was assessed. Scale 0-100, 0=causes pain, 100=very comfortable.	1 week per intervention