- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02965820
OPTI-FREE® PureMoist® for Presbyopic Contact Lens Wearers
June 15, 2018 updated by: Alcon, a Novartis Company
Clinical Study of OPTI-FREE® PureMoist® for Presbyopic Contact Lens Wearers
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
122
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: OFPM, then HMPS
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.
|
Other Names:
Subject's habitual contact lens brand worn in a daily wear modality for 30 days.
|
Other: HMPS, then OFPM
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.
|
Other Names:
Subject's habitual contact lens brand worn in a daily wear modality for 30 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score at Day 30
Time Frame: Day 30, each product
|
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.
|
Day 30, each product
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 16, 2016
Primary Completion (Actual)
April 1, 2017
Study Completion (Actual)
April 1, 2017
Study Registration Dates
First Submitted
November 15, 2016
First Submitted That Met QC Criteria
November 15, 2016
First Posted (Estimate)
November 17, 2016
Study Record Updates
Last Update Posted (Actual)
July 12, 2018
Last Update Submitted That Met QC Criteria
June 15, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LCO115-P001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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