Clinical Evaluation of Daily Disposable Contact Lenses

Myopia Clinical Trial

Official title:

Single-Center Clinical Evaluation of Daily Disposable Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02097030
• Other study ID #: EX-MKTG-46
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: April 2014

Study information

• Verified date: July 2020
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of California, Berkeley Clinical Research Center (UCB-CRC)	Berkeley	California

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Subjective Response for Comfort	Participant's subjective response for comfort measured at baseline and 3 day follow-up. (Continuous Comfort Scale 0-100, 0=cannot be worn/causes pain, 100=cannot be felt ever)	Baseline and 3 day follow-up
Secondary	Subjective Response for Vision	Participant's subjective response for vision measured at baseline and at 3 day follow-up of daily disposable wear of lenses. (Vision Scale 0-100, 0=very blurry, 100=very clear).	Baseline and 3 day follow-up
Secondary	Subjective Response for Insertion	Participant's subjective response for insertion measured at baseline. (Insertion Handling Scale 0-100, 0=very hard to handle, 100=very easy to handle).	Baseline
Secondary	Subjective Response for Handling (Insertion and Removal)	Participant's subjective response for handling (insertion and removal) measured at 3 day follow-up of daily disposable wear of lenses. (Handling Scale 0-100, 0=very hard to handle, 100=very easy to handle).	3 days follow-up
Secondary	Subjective Response for Dryness	Participant's subjective response for dryness, measured at baseline and after 3 day follow-up of daily disposable wear of lenses. (Dryness Scale 0-100, 0=Cannot be worn/extremely dry, 100=no dryness experienced at any time).	3 Days Follow-up
Secondary	Overall Satisfaction, Vision	Participant's subjective response for overall vision satisfaction. Measured after 3 days daily disposable wear of lenses. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.	3 Days Follow-up
Secondary	Overall Satisfaction, Comfort	Participant's subjective response for overall comfort satisfaction. Measured after 3 days daily disposable wear of lenses. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.	3 Days Follow-up
Secondary	Overall Satisfaction, Handling	Participant's subjective response for overall handling satisfaction. Measured after 3 days of daily disposable lens wear. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.	3 Days
Secondary	Overall Satisfaction, Dryness	Participant's subjective response for overall dryness satisfaction. Measured after 3 days daily disposable wear of lenses. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.	3 Days Follow-up
Secondary	Overall Satisfaction	Participant's subjective response for overall satisfaction. Measured after 3 days of daily disposable lens wear. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.	3 Days Follow-up
Secondary	Lens Fit and Performance - Wettability (Baseline and 3 Days Follow-up)	The investigator's objective assessment for contact lens fit and performance - wettability. Measured at baseline (10-15mins settling) for both study pairs. Wettability (scale 0-4, 0.25 steps, 0=excellent, 4 severely reduced).	Baseline and 3 days follow-up
Secondary	Lens Fit and Performance - Deposits (Baseline and 3 Days Follow-up)	The investigator's objective assessment for contact lens fit and performance - deposits. Measured at baseline (10-15mins settling) for both study pairs. Deposits (scale 0-4, 0.25 steps, 0=excellent, 4 severely reduced);	Baseline and 3 days follow-up
Secondary	Lens Fit and Performance - Debris (Baseline and 3 Day Follow-up)	The investigator's objective assessment for contact lens fit and performance - debris. Measured at baseline (10-15mins settling) for both study pairs. (Debris scale 0-4; 0.25 steps; 0=no debris, 4=significant debris)	Baseline and 3 day follow-up
Secondary	Lens Fit and Performance - Movement (Baseline and 3 Days Follow-up)	The investigator's objective assessment for contact lens fit and performance - movement. Measured at baseline (10-15mins settling) for both study pairs. Movement (scale in millimeters).	Baseline and 3 days follow-up
Secondary	Lens Fit and Performance - Fit Acceptance	The investigator's objective assessment for contact lens fit and performance - fit acceptance. Measured at baseline and 3 day follow-up (10-15mins settling) for both study pairs. Fit acceptance (Scale 0-4, 0.25 steps, 0=Should not be worn, 4=Perfect).	Baseline and 3 day follow-up
Secondary	Lens Fit and Performance - Tightness (Baseline and 3 Day Follow-up)	The investigator's objective assessment for contact lens fit and performance - tightness. Measured at baseline (10-15mins settling) for both study pairs. Tightness (Scale 0-4, 0.25 steps, 0=Should not be worn, 4=Perfect).	Baseline and 3 day follow-up
Secondary	Ocular Health - Biomicroscopy	The investigator's objective assessment of ocular health assessed for each study Pair after 3 days wear by biomicroscopy. Bulbar and Limbal Hyperemia; Corneal Staining Type, Extent and Depth, Conjunctival Staining and Indentation. BrienHolden Vision Institute Continuous Scale: 1-4, 0.5 steps (1=Very, 2=Slight, 3=Moderate, 4=Severe)	3 Days Follow-up