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OpenTrials
Completed

NCT Number: NCT03525704

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

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

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Andre Vision and Device Research

West Linn, Oregon, 97068, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Saline Solution Enriched

Device

Sterile single dose, Preservative Free, PH Balanced, Enriched with IONs rinsing and Insertion Solution

Other names: NutriFill, GatorFill

Saline Rinse Solution

Device

sterile unit dose non-preserved, 0.9% NaCl (normal saline) solution i

Other names: LacriPure, ScleralFil

Primary outcomes

  1. Patient Subjective Symptoms and Wear Time Survey

    Time frame: 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 outcomes

  1. Biomicroscopy Findings

    Time frame: 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

    Time frame: 1 Month

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

Sponsors and collaborators

Lead sponsor

Contamac Ltd

Industry

Collaborators

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

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 16, 2018
Registry last updated
Jan 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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