Back to resultsOPTI-FREE® PureMoist® for Presbyopic Contact Lens Wearers
Primary Purpose
Presbyopia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Opti-Free® PureMoist® contact lens solution
Habitual Multi-Purpose Contact Lens Solution
Habitual Contact Lenses
Sponsored by
About this trial
This is an interventional supportive care trial for Presbyopia focused on measuring Contact lens induced dryness
Eligibility Criteria
Inclusion Criteria:
- Must sign an informed consent document;
- Current adapted two-week/monthly replacement soft contact lens wearers (at least 2 months) with symptoms of contact lens induced dryness;
- Near spectacle add of +0.50 or greater;
- Best corrected visual acuity (BCVA) to 20/30 or better in each eye at distance;
- Willing to wear lenses for a minimum of 5 days per week, 6 hours per day, and attend all study visits;
- Currently using a non-Alcon multi-purpose solution to care for lenses (at least 2 months);
- Use of digital devices (eg, smart phone, tablet, laptop computer, or desktop computer) for 20 consecutive minutes at least twice a week and willing to continue the same pattern for the duration of the study;
- Other protocol-specific inclusion criteria may apply.
Exclusion Criteria:
- Extended wear contact lens wearer (sleeps in lenses 1 or more nights per week);
- Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear as determined by the investigator;
- Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator, including use of any topical ocular medications that would require instillation during contact lens wear;
- Monocular (only 1 eye with functional vision) or fit with only 1 lens;
- Known sensitivity to any ingredients in OFPM;
- Prior refractive surgery;
- History of herpetic keratitis, ocular surgery, or irregular cornea;
- Pathological dry eye that precludes contact lens wear;
- Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study;
- Participation in any clinical study within 30 days of Visit 1;
- Currently using or have not discontinued Restasis®, Xiidra® or a topical steroid within the past 7 days;
- Other protocol-specific exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
OFPM, then HMPS
HMPS, then OFPM
Arm Description
OPTI-FREE® PureMoist® multi-purpose contact lens solution in Period 1, followed by subject's habitual multi-purpose contact lens solution (HMPS) in Period 2. Each product used daily per packaging instructions with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles.
Subject's habitual multi-purpose contact lens solution in Period1, followed by OPTI-FREE® PureMoist® contact lens solution in Period 2. Each product used daily per packaging instructions with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles.
Outcomes
Primary Outcome Measures
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score at Day 30
CLDEQ-8 score (assessment of contact lens discomfort) was obtained by adding the numerical responses to each of 8 items. Individual scales ranged from 0-4, 0-5, and 1-6, with a resultant overall score from 1 minimum to 37 maximum. A lower CLDEQ-8 score indicates less frequent or less intense symptoms.
Secondary Outcome Measures
Full Information
NCT ID
NCT02965820
First Posted
November 15, 2016
Last Updated
June 15, 2018
Sponsor
Alcon, a Novartis Company
1. Study Identification
Unique Protocol Identification Number
NCT02965820
Brief Title
OPTI-FREE® PureMoist® for Presbyopic Contact Lens Wearers
Official Title
Clinical Study of OPTI-FREE® PureMoist® for Presbyopic Contact Lens Wearers
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
December 16, 2016 (Actual)
Primary Completion Date
April 1, 2017 (Actual)
Study Completion Date
April 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon, a Novartis Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate OPTI-FREE® PureMoist® (OFPM) compared to non-HYDRAGLYDE® multi-purpose contact lens solutions in presbyopes currently wearing soft contact lenses and experiencing symptoms of dryness.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia
Keywords
Contact lens induced dryness
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
122 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OFPM, then HMPS
Arm Type
Other
Arm Description
OPTI-FREE® PureMoist® multi-purpose contact lens solution in Period 1, followed by subject's habitual multi-purpose contact lens solution (HMPS) in Period 2. Each product used daily per packaging instructions with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles.
Arm Title
HMPS, then OFPM
Arm Type
Other
Arm Description
Subject's habitual multi-purpose contact lens solution in Period1, followed by OPTI-FREE® PureMoist® contact lens solution in Period 2. Each product used daily per packaging instructions with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles.
Intervention Type
Device
Intervention Name(s)
Opti-Free® PureMoist® contact lens solution
Other Intervention Name(s)
OPTI-FREE® PureMoist®
Intervention Type
Device
Intervention Name(s)
Habitual Multi-Purpose Contact Lens Solution
Intervention Type
Device
Intervention Name(s)
Habitual Contact Lenses
Intervention Description
Subject's habitual contact lens brand worn in a daily wear modality for 30 days.
Primary Outcome Measure Information:
Title
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score at Day 30
Description
CLDEQ-8 score (assessment of contact lens discomfort) was obtained by adding the numerical responses to each of 8 items. Individual scales ranged from 0-4, 0-5, and 1-6, with a resultant overall score from 1 minimum to 37 maximum. A lower CLDEQ-8 score indicates less frequent or less intense symptoms.
Time Frame
Day 30, each product
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must sign an informed consent document;
Current adapted two-week/monthly replacement soft contact lens wearers (at least 2 months) with symptoms of contact lens induced dryness;
Near spectacle add of +0.50 or greater;
Best corrected visual acuity (BCVA) to 20/30 or better in each eye at distance;
Willing to wear lenses for a minimum of 5 days per week, 6 hours per day, and attend all study visits;
Currently using a non-Alcon multi-purpose solution to care for lenses (at least 2 months);
Use of digital devices (eg, smart phone, tablet, laptop computer, or desktop computer) for 20 consecutive minutes at least twice a week and willing to continue the same pattern for the duration of the study;
Other protocol-specific inclusion criteria may apply.
Exclusion Criteria:
Extended wear contact lens wearer (sleeps in lenses 1 or more nights per week);
Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear as determined by the investigator;
Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator, including use of any topical ocular medications that would require instillation during contact lens wear;
Monocular (only 1 eye with functional vision) or fit with only 1 lens;
Known sensitivity to any ingredients in OFPM;
Prior refractive surgery;
History of herpetic keratitis, ocular surgery, or irregular cornea;
Pathological dry eye that precludes contact lens wear;
Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study;
Participation in any clinical study within 30 days of Visit 1;
Currently using or have not discontinued Restasis®, Xiidra® or a topical steroid within the past 7 days;
Other protocol-specific exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager, CPM
Organizational Affiliation
Alcon, A Novartis Division
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
OPTI-FREE® PureMoist® for Presbyopic Contact Lens Wearers
We'll reach out to this number within 24 hrs