Clinical Evaluation of Daily Disposable Contact Lenses

NCT ID: NCT02097030

Last Updated: 2020-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2014-04-30

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.

Detailed Description

Double-masked, randomised, controlled crossover trial. Subjects were randomized to wear one or the other of the conventional hydriogel lenses; all subjects wore the filcon II 3 lenses. The first randomly assigned lens type was worn for 3 days, with daily replacement, followed by 3 days of wear of the other lens type, with daily replacement.

Conditions

Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

etafilcon A lens

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.

Group Type: ACTIVE_COMPARATOR

etafilcon A

Intervention Type: DEVICE

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

nelfilcon A lens

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.

Group Type: ACTIVE_COMPARATOR

nelfilcon A

Intervention Type: DEVICE

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

filcon II 3 lens

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.

Group Type: ACTIVE_COMPARATOR

filcon II 3

Intervention Type: DEVICE

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

Interventions

filcon II 3

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

Intervention Type: DEVICE

etafilcon A

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

Intervention Type: DEVICE

nelfilcon A

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

Intervention Type: DEVICE

Other Intervention Names

Silicone Hydrogel Daily Disposable Contact Lens; Hydrogel Daily Disposable Contact Lens; Hydrogel Daily Disposable Contact Lens

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CooperVision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Meng C Lin, OD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Berkeley

Locations

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

Berkeley, California, United States

Countries

United States

Other Identifiers

EX-MKTG-46

Identifier Type: -

Identifier Source: org_study_id