Comparative Study of Two Marketed 1-day Soft Contact Lenses

Myopia Clinical Trial

Official title:

Clinical Performance of Ocufilcon D With a Wetting Agent to Ocufilcon B

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01464255
• Other study ID #: CV-OMC-01
• Status: Completed
• Phase: N/A
• First received: October 26, 2011
• Last updated: August 15, 2014
• Start date: August 2011
• Est. completion date: November 2011

Study information

• Verified date: August 2014
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study is designed to evaluate ocufilcon D lens compared to ocufilcon B lens in a 1-week crossover, daily wear regimen.

Description:

This study is designed to evaluate 2 daily disposable contact lenses that are both currently cleared for the USA market. Study of the ocufilcon D lens compared to the ocufilcon B lens in a 1-week crossover, daily wear regimen. The primary objective is the comparison of fitting characteristics. The secondary objective is the comparison of comfort, end of day comfort and dryness measures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: November 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Has had a self reported oculo-visual examination in the last two years.

• Is able to wear the study lenses for at least eight hours a day, seven days a week

• Aged 18-40 years and has full legal capacity as a volunteer

• Has a distance contact lens prescription from -0.25 and -6.00D inclusive

• Has spectacle astigmatism of < 1.00D in each eye

• Baseline vision of 20/20 best-corrected in each eye.

• Is correctable to at least 20/25 distance visual acuity with study contact lenses in each eye

• Has read and understood the consent form and willing to sign consent form

• Willing and able to follow participant instructions and attend the required study visits Has worn soft contact lenses for at least two weeks prior to the study (daily wear only).

Exclusion Criteria:

• Currently wears contact lenses on an extended wear basis.

• Not a current or past wearer of the ocufilcon B 52% 1-day lenses.

• Has undergone anterior ocular surgery

• Is aphakic

• Has never worn contact lenses before

• Has any systemic disease which clinically contraindicates contact lenses

• Has active ocular disease or severe insufficiency of lacrimal secretion (dry eye)

• Use of systemic or topical medications that will affect ocular health or visual performance

• Slit lamp findings with a grading of greater than 1.0 using the grading scales in Appendix 3

• Not possible to achieve a satisfactory fit with the lens design used in the study

• Has keratoconus or other corneal irregularity

• Participating in another eye-related clinical trial

• Pregnant, lactating or planning a pregnancy

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• ocufilcon D
Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
• ocufilcon B
Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.

Locations

Country	Name	City	State
United States	Clinical Research Center, U.C. Berkeley, School of Optometry	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	Lens Fit - Decentration After Insertion	The ophthalmologist's objective assessment of lens fit measurement of decentration after insertion (20 minutes settling) of Pair #1 (measured at baseline visit) and Pair #2 (measured at 7 days after baseline visit). (mm, horizontal and vertical).	Baseline and 7 days from baseline visit	No
Primary	Lens Fit - Decentration at One Week	The ophthalmologist's objective assessment of lens fit measurement of decentration of Pair #1 (measured at 7 days after baseline visit) and Pair #2 (measured at 14 days after baseline visit). Each pair worn for one week daily disposable wear basis (at least 8 hours per day, 7 days per week). Lenses worn minimum 2 hours prior to visit. (mm, horizontal and vertical).	7 days and 14 days from baseline visit	No
Primary	Lens Fit - Tightness After Insertion	The ophthalmologist's rating of lens fit measurement of push-up tightness after insertion (20 minutes settling) of Pair #1 (measured at baseline visit) and Pair #2 (measured at 7 days after baseline visit). (0-100%, 5% steps, 0%=excessively loose, 50%=optimum, 100%=excessively tight ).	Baseline and 7 days from baseline visit	No
Primary	Lens Fit - Tightness at One Week	The ophthalmologist's rating of lens fit measurement of push-up tightness of Pair #1 (measured at 7 days after baseline visit) and Pair #2 (measured at 14 days after baseline visit). Each pair worn for one week daily disposable wear basis (at least 8 hours per day, 7 days per week). Lenses worn minimum 2 hours prior to visit. (0-100%, 5% steps, 0%=excessively loose, 50%=optimum, 100%=excessively tight ).	7 days and 14 days from baseline visit	No
Primary	Lens Fit - Post-Blink Lens Movement After Insertion	The ophthalmologist's objective assessment of lens fit measurement of post-blink lens movement after insertion (20 minutes settling) of Pair #1 (measured at baseline visit) and Pair #2 (measured at 7 days after baseline visit). (mm).	Baseline and 7 days from baseline visit	No
Primary	Lens Fit - Post-Blink Lens Movement Prior to Removal	The ophthalmologist's objective assessment of lens fit measurement of post-blink lens movement prior to removal of Pair #1 (measured at 7 days after baseline visit) and Pair #2 (measured at 14 days after baseline visit). (mm).	7 days and 14 days from baseline visit	No
Secondary	Overall Preference - Comfort After Insertion	Participant's subjective rating for overall preference of lens comfort immediately after insertion for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices - Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.	14 days from baseline visit	No
Secondary	Overall Preference - Comfort Before Removal	Participant's subjective rating for overall preference of lens comfort immediately before removal for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices - Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.	14 days from baseline visit	No
Secondary	Overall Preference - Dryness After Insertion	Participant's subjective rating for overall preference of lens dryness immediately after insertion for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices - Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.	14 days from baseline visit	No
Secondary	Overall Preference - Dryness Before Removal	Participant's subjective rating for overall preference of lens dryness immediately before removal for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices - Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.	14 days from baseline visit	No
Secondary	Overall Preference - Handling, Inserting	Participant's subjective rating for overall preference of lens ease of handling at inserting for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices - Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.	14 days from baseline visit	No
Secondary	Overall Preference - Handling, Removing	Participant's subjective rating for overall preference of lens ease of handling at removing for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices - Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.	14 days from baseline visit	No
Secondary	Overall Lens Pair Preference	Participant's subjective rating for overall preference for lens pair #1 or Pair #2 based on comfort, vision and handling. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices - Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.	14 days from baseline visit	No