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OPTI-FREE® PureMoist® for Presbyopic Contact Lens Wearers

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ClinicalTrials.gov Identifier: NCT02965820
Recruitment Status : Completed
First Posted : November 17, 2016
Results First Posted : April 26, 2018
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( Alcon, a Novartis Company )

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.

Condition or disease Intervention/treatment Phase
Presbyopia Device: Opti-Free® PureMoist® contact lens solution Device: Habitual Multi-Purpose Contact Lens Solution Device: Habitual Contact Lenses Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Clinical Study of OPTI-FREE® PureMoist® for Presbyopic Contact Lens Wearers
Actual Study Start Date : December 16, 2016
Actual Primary Completion Date : April 1, 2017
Actual Study Completion Date : April 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
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.
Device: Opti-Free® PureMoist® contact lens solution
Other Name: OPTI-FREE® PureMoist®

Device: Habitual Multi-Purpose Contact Lens Solution
Device: Habitual Contact Lenses
Subject's habitual contact lens brand worn in a daily wear modality for 30 days.

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.
Device: Opti-Free® PureMoist® contact lens solution
Other Name: OPTI-FREE® PureMoist®

Device: Habitual Multi-Purpose Contact Lens Solution
Device: Habitual Contact Lenses
Subject's habitual contact lens brand worn in a daily wear modality for 30 days.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02965820


Sponsors and Collaborators
Alcon, a Novartis Company
Investigators
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Study Director: Clinical Project Manager, CPM Alcon, A Novartis Division
  Study Documents (Full-Text)

Documents provided by Alcon Research ( Alcon, a Novartis Company ):
Study Protocol  [PDF] January 3, 2017
Statistical Analysis Plan  [PDF] December 11, 2016


Additional Information:
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Responsible Party: Alcon, a Novartis Company
ClinicalTrials.gov Identifier: NCT02965820     History of Changes
Other Study ID Numbers: LCO115-P001
First Posted: November 17, 2016    Key Record Dates
Results First Posted: April 26, 2018
Last Update Posted: July 12, 2018
Last Verified: March 2018
Keywords provided by Alcon Research ( Alcon, a Novartis Company ):
Contact lens induced dryness
Additional relevant MeSH terms:
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Presbyopia
Refractive Errors
Eye Diseases
Contact Lens Solutions
Pharmaceutical Solutions
Disinfectants
Anti-Infective Agents