Clinical Evaluation of Daily Disposable Contact Lenses

NCT02097030 | Completed Results

• 1 other identifier: EX-MKTG-46
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to compare the overall subjective preference of filcon II 3 daily disposable silicone hyrogel contact lenses compared to etafilcon A and nelfilcon A daily disposable conventional hydrogel contact lenses.

Conditions

Myopia

Outcome Measures

Primary Outcomes (2)

• Overall Lens Preference - All Study Lenses

  Participant's subjective response for overall lens preference after 3 days of daily disposable wear of each pair of lenses. Surveyed at exit. (4 possible ratings: Strongly prefer pair#1, Slightly prefer pair #1, Slightly prefer pair #2, Strongly prefer pair #2).

  Study Exit

• Overall Lens Preference - Hydrogel vs. Filcon II 3

  Participant's subjective response for overall lens preference after 3 days of daily disposable wear of each pair. Surveyed at exit. (4 possible ratings: Strongly prefer pair#1, Slightly prefer pair #1, Slightly prefer pair #2, Strongly prefer pair #2).

  Study Exit

Secondary Outcomes (17)

• Subjective Response for Comfort

  Baseline and 3 day follow-up

• Subjective Response for Vision

  Baseline and 3 day follow-up

• Subjective Response for Insertion

  Baseline

• Subjective Response for Handling (Insertion and Removal)

  3 days follow-up

• Subjective Response for Dryness

  3 Days Follow-up

Study Arms (3)

etafilcon A lens

ACTIVE COMPARATOR

Participants were randomized to either the etafilcon A or the nelfilcon A lens for three days and then both groups wore the filcon II 3 lens for three days, without washout period between lens types.

Device: etafilcon A

nelfilcon A lens

ACTIVE COMPARATOR

Participants were randomized to either the etafilcon A or the nelfilcon A lens for three days and then both groups wore the filcon II 3 lens for three days, without washout period between lens types.

Device: nelfilcon A

filcon II 3 lens

ACTIVE COMPARATOR

Participants were randomized to either the etafilcon A or the nelfilcon A lens for three days and then both groups wore the filcon II 3 lens for three days, without washout period between lens types.

Device: filcon II 3

Interventions

filcon II 3 DEVICE

Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.

Also known as: Silicone Hydrogel Daily Disposable Contact Lens

filcon II 3 lens

etafilcon A DEVICE

Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.

Also known as: Hydrogel Daily Disposable Contact Lens

etafilcon A lens

nelfilcon A DEVICE

Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.

Also known as: Hydrogel Daily Disposable Contact Lens

nelfilcon A lens

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Is between 18 and 40 years of age (inclusive)
• Has had a self-reported visual exam in the last two years
• Is an adapted soft CL wearer
• Must be able to wear their lenses at least 3 full days, 10 hours per day, assuming there are no contraindications for doing so
• Has a CL spherical prescription between - 1.00 and - 6.00 (inclusive)
• Has less than 1.25 D spectacle cylinder in each eye.
• Baseline vision of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
• Is correctable to at least 20/25 distance visual acuity with study contact lenses in each eye
• Has clear corneas and no active ocular disease
• Has read, understood and signed the information consent letter
• Is willing to comply with the wear schedule (at least 3 full days)
• Is willing to comply with the visit schedule

You may not qualify if:

• Has never worn contact lenses before.
• Currently wears rigid gas permeable contact lenses.
• Has a history of not achieving comfortable CL wear (3 days per week; \> 8 hours/day)
• Has a CL prescription outside the range of - 1.00 to -6.00D
• Has a spectacle cylinder greater than -1.25D of cylinder in either eye.
• Has best corrected spectacle distance vision worse then 20/25 in either eye.
• Has any systemic disease affecting ocular health.
• Is using any systemic or topical medications, (includes rewetting drops, artificial tears and allergy drops), that will affect ocular health. Occasional use is acceptable but not during the trial.
• Has any ocular pathology or severe insufficiency of lacrimal secretion
• Has persistent, clinically significant corneal or conjunctival staining
• Has active neovascularization or any central corneal scars.
• Is aphakic.
• Is presbyopic.
• Has undergone corneal refractive surgery.
• Is participating in any other type of eye related clinical or research study.

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

University of California, Berkeley Clinical Research Center (UCB-CRC)

Berkeley, California, 94720-2020, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Jose A. Vega, OD, Sr. Manager Global Medical Scientific Affairs
• Organization: CooperVision

jvega@coopervision.com

(925) 621-3761

Study Officials

• Meng C Lin, OD, PhD

  University of California, Berkeley

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: March 24, 2014
• First Posted: March 26, 2014
• Study Start: March 1, 2014
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: July 31, 2020
• Results First Posted: February 15, 2016

Record last verified: 2020-07

Locations

US (1)