A Two-Week Crossover Dispensing Evaluation Of Orion Daily Wear Soft Contact Lens

NCT04585646 | Completed Results DMC FDA Device

• 1 other identifier: CV-20-18
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study is to evaluate the clinical performance of test lens (Orion) in comparison with control lens (Gemini) over a period of two weeks of wear.

Conditions

Myopia

Outcome Measures

Primary Outcomes (6)

• Subjective Response for Vision Satisfaction

  Subjective Response for Vision Satisfaction assessed on 7-point Likert (Very satisfied, Satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied)

  Baseline - After 10 minutes of lens dispense

• Subjective Response for Overall Vision Satisfaction

  Subjective Response for Vision satisfaction assessed on 7-point Likert (Very satisfied, Satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied)

  2 Weeks

• Subjective Response for Overall Vision Satisfaction

  Subjective Response for Vision satisfaction assessed on 7-point Likert (Very satisfied, Satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied)

  2 Weeks - at night

• Subjective Response for Overall Vision Quality

  Subjective Response for Overall Vision quality assessed on a 0-100 scale (0- Unacceptable, 100- Excellent Vision)

  Baseline - After 10 minutes of lens dispense

• Subjective Response for Overall Vision Quality

  Subjective Response for Overall Vision Quality assessed on a 0-100 scale (0- Unacceptable, 100- Excellent Vision)

  2 weeks

• Subjective Response for Overall Vision Quality

  Subjective Response for Overall Vision Quality assessed on a 0-100 scale (0- Unacceptable, 100- Excellent Vision)

  2 weeks - Night Driving

Secondary Outcomes (19)

• Subjective Overall Comfort Satisfaction

  Baseline - After 10 minutes of lens dispense

• Subjective Overall Comfort Satisfaction

  2 Weeks

• Subjective Preference for Comfort

  2 weeks

• Lens Surface Wettability Performance

  Baseline - After 10 minutes of lens dispense

• Lens Surface Wettability Performance

  2 weeks

Study Arms (2)

Orion then Gemini

EXPERIMENTAL

Subjects will be randomized to wear Orion daily disposable contact lens then Gemini daily disposable contact lens for 2 weeks in this randomized, cross-over bilateral dispensing study.

Device: Orion daily disposable contact lens; Device: Gemini daily disposable contact lens

Gemini then Orion

EXPERIMENTAL

Subjects will be randomized to wear Gemini daily disposable contact lens then Orion daily disposable contact lens for 2 weeks in this randomized, cross-over bilateral dispensing study.

Device: Orion daily disposable contact lens; Device: Gemini daily disposable contact lens

Interventions

Orion daily disposable contact lens DEVICE

Subjects will be randomized to wear Orion lens for 2 weeks.

Gemini then Orion; Orion then Gemini

Gemini daily disposable contact lens DEVICE

Subjects will be randomized to wear Gemini lens for 2 weeks.

Gemini then Orion; Orion then Gemini

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Is at least 18 years of age and has full legal capacity to volunteer.
• Is no greater than 55 years of age.
• Has read and understood the information consent letter.
• Is willing and able to follow instructions and maintain the appointment schedule.
• Is an adapted soft contact lens wearer having worn lenses for a minimum of 4 weeks prior to the study.
• Has spectacle cylinder ≤1.00D in both eyes.
• Has spherical contact lens power requirement between -1.00D and -6.00D in both eyes.
• Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/20 in each eye.
• Wears CLs in both eyes (monovision acceptable, but not monofit)
• Has clear corneas and no active ocular disease.
• Has not worn lenses for at least 12 hours before the examination.
• Is willing to wear the study contact lenses for a minimum 8 hours per day/6 days per week

You may not qualify if:

• 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 affect the wearing of contact lenses.
• Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
• Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
• Is aphakic.
• Has strabismus/amblyopia.
• Has undergone corneal refractive surgery.
• Is pregnant, lactating or planning a pregnancy.
• Is participating in any concurrent clinical or research study.

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

CORL, Indiana University

Bloomington, Indiana, 47405, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Lee Hall, PhD
• Organization: CooperVision, Inc

lhall@coopervision.com

(925) 251 6684

Study Officials

• Pete S Kollbaum

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 14, 2020
• Study Start: September 14, 2020
• Primary Completion: November 30, 2020
• Study Completion: December 31, 2020
• Last Updated: May 10, 2022
• Results First Posted: May 10, 2022

Record last verified: 2022-04

Locations

US (1)