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Evaluation of Contact Lens Saline Solutions With Scleral GP Contact Lens Wearers Experiencing Fogging

Sponsor
Contamac Ltd (Industry)
Overall Status
Completed
CT.gov ID
NCT03525704
Collaborator
Andre Vision and Device Research (Other), The Contact Lens Center at Optique (Other), Premiere Vision Group (Other), Havasu Eye Center (Other)
36
Enrollment
1
Location
2
Arms
8.2
Actual Duration (Months)
4.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Evaluation of saline solutions used with scleral rigid gas permeable contact lens wearers experiencing debris in the post lens tear reservoir

Condition or Disease Intervention/Treatment Phase
  • Device: Saline Solution Enriched
  • Device: Saline Rinse Solution
 N/A

Detailed Description

One-month, approximately 36 subjects enrolled (~12/site), randomized, double-masked crossover trial.

Existing scleral rigid gas permeable (RGP) contact lens wearing subjects are randomly assigned (block) to different arms of the trial and receive different saline solutions for use sequentially for 2-week periods. The subjects will continue to wear their existing scleral GP lenses if lens fit is acceptable following an initial evaluation. Subjects will agree to complete a survey administered daily (via email) that will address contact lens wear time and subjective symptoms.

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
One-month, approximately 36 subjects enrolled (~12/site), randomized, double-masked crossover trial.One-month, approximately 36 subjects enrolled (~12/site), randomized, double-masked crossover trial.
Masking:
Double (Participant, Investigator)
Masking Description:
Randomized, Double-Masked
Primary Purpose:
Treatment
Official Title:
Evaluation of Contact Lens Saline Solutions With Scleral GP Contact Lens Wearers Experiencing Fogging
Actual Study Start Date :
Apr 9, 2018
Actual Primary Completion Date :
Dec 15, 2018
Actual Study Completion Date :
Dec 15, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Saline Solution Enriched

Saline Solution enriched with electrolytes and PH balanced to mimic normal tears

Device: Saline Solution Enriched
Sterile single dose, Preservative Free, PH Balanced, Enriched with IONs rinsing and Insertion Solution
Other Names:
  • NutriFill
  • GatorFill

    		•
    Active Comparator: Saline Rinse Solution

    Saline Solution .9% NaCL

    Device: Saline Rinse Solution
    sterile unit dose non-preserved, 0.9% NaCl (normal saline) solution i
    Other Names:
  • LacriPure
  • ScleralFil

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Patient Subjective Symptoms and Wear Time Survey [1 Month]

      Participant Survey on Lens Comfort (based on a scale of 0 to 5), Symptoms (graded based on frequency (rarely/sometimes/often/always) and severity(slight/moderate/severe)), Total Wear Time (reported as hours per day) and How Many Times Lenses are Removed Daily (reported as number of times per day)

    Secondary Outcome Measures

    1. Biomicroscopy Findings [1 Month]

      Edema, Bulbar Redness, Limbal Redness, Corneal Vascularization, Corneal Infiltrates, Palpebral Conjunctival Observations and Corneal Staining are evaluated on a grading scale of 0 to 4.

    2. Visual Acuity [1 Month]

      Visual acuity (in units of Logmar) is evaluated with subject wearing habitual contact lenses.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    Inclusion Criteria:•

    • Daily wear large diameter (scleral) rigid gas permeable contact lens wearers in design with acceptable fit

    • 18 years old or above.

    • Agree to and sign Informed Consent.

    • Correctable to at least 20/40 distance visual acuity in each eye.

    • Presence of debris or "fogging" in post lens tear film reservoir (PLTR).

    Exclusion Criteria:

    • Extended wear contact lens wearers

    • Require concurrent ocular medication.

    • Grade 2 or more slit lamp findings (does not include fogging assessment).

    • Eye injury or surgery within twelve weeks immediately prior to enrolment for this trial.

    • Currently enrolled in an ophthalmic clinical trial.

    • Pregnant or lactating

    • Evidence of active ophthalmic disease or abnormality including glaucoma, chorioretinitis, central retinal artery or vein occlusion, intraocular or ocular infection.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Andre Vision and Device Research West Linn Oregon United States 97068

    Sponsors and Collaborators

    • Contamac Ltd
    • Andre Vision and Device Research
    • The Contact Lens Center at Optique
    • Premiere Vision Group
    • Havasu Eye Center

    Investigators

    • Study Director: Bret Andre, MS, ABOe, AVD Research

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Contamac Ltd
    ClinicalTrials.gov Identifier:
    NCT03525704
    Other Study ID Numbers:
    • AVDR 2018-01 v1.2
    First Posted:
    May 16, 2018
    Last Update Posted:
    Jan 27, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Contamac Ltd
    Fogging
    Insertion Solutions
    RGP
    Scleral
    Contact Lenses
    Additional relevant MeSH terms:
    Pharmaceutical Solutions

    Study Results

    No Results Posted as of Jan 27, 2021