Dispensing Evaluation of a Prototype Contact Lens and a Marketed Contact Lens

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01094743

Enrollment

Registered

2010-03-29

Start date

2010-02-01

Completion date

2010-03-01

Last updated

2018-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

Brief summary

The purpose of this study is to compare visual acuity and redness of eyes between a prototype contact lens and an already marketed contact lens.

Interventions

DEVICEgalyfilcon A prototype lens

Silicone hydrogel contact lens

DEVICElotrafilcon B lens

Silicon Hydrogel contact lens

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 39 Years

Healthy volunteers

Inclusion criteria

1. The subject must be at least 18 years of age and no more than 39 years of age. 2. The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of DW for a minimum of 1 month prior to the study) and willing to wear the study lenses on a daily wear basis (defined as a minimum of 6 hours of wear per day at least five days of the week) for the duration of the study. 3. The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 9.00D. 4. Any cylinder power must be ≤ -0.75D. 5. The subject must have visual acuity best correctable to 20/25+3 or better for each eye. 6. The subject must read and sign the Statement of Informed Consent. 7. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion criteria

1. Ocular or systemic allergies or disease which might interfere with contact lens wear. 2. Systemic disease or use of medication which might interfere with contact lens wear. 3. Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear. 4. Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear. 5. Any ocular infection. 6. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. 7. Pregnancy or lactation. 8. Diabetes. 9. Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV). 10. Habitual contact lens type is toric, multifocal, or is worn as extended wear.

Design outcomes

Primary

Measure	Time frame	Description
Visual Acuity Monocular	after 1 week of lens wear	Snellen monocular visual acuity measurement
Visual Acuity Binocular	after 1 week of lens wear	Snellen binocular visual acuity measurement
Subjective Assessment of Lens Comfort	after 1 week of lens wear	Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.
Subjective Assessment of Quality of Vision	after 1 week of lens wear	Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.

Secondary

Measure	Time frame	Description
Bulbar Redness	after 1 week of lens wear	Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.
Subjective Assessment of Lens Comfort	10 minutes after lens insertion at time of initial lens fitting	Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.
Limbal Redness	after 1 week of lens wear	Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Galyfilcon A Prototype Lens / Lotrafilcon B Lens All enrolled subjects were to wear both lenses through the course of the study.	52
Total	52

Withdrawals & dropouts

Period	Reason	FG000
Period 1	Unsatisfactory comfort at lens fitting	2

Baseline characteristics

Characteristic	Galyfilcon A Prototype Lens / Lotrafilcon B Lens
Age, Continuous	28 years STANDARD_DEVIATION 5.76
Region of Enrollment United States	52 participants
Sex: Female, Male Female	17 Participants
Sex: Female, Male Male	35 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 52
serious Total, serious adverse events	0 / 52

Outcome results

Primary

Subjective Assessment of Lens Comfort

Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.