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

NCT03525704 | Completed FDA Device

• 1 other identifier: AVDR 2018-01 v1.2
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Contact Lens Complication; Debris in Post Lens Tear Reservoir

Keywords

Fogging; Insertion Solutions; RGP; Scleral; Contact Lenses

Outcome Measures

Primary Outcomes (1)

• Patient Subjective Symptoms and Wear Time Survey

  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)

  1 Month

Secondary Outcomes (2)

• Biomicroscopy Findings

  1 Month

• Visual Acuity

  1 Month

Study Arms (2)

Saline Solution Enriched

EXPERIMENTAL

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

Device: Saline Solution Enriched

Saline Rinse Solution

ACTIVE COMPARATOR

Saline Solution .9% NaCL

Device: Saline Rinse Solution

Interventions

Saline Solution Enriched DEVICE

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

Also known as: NutriFill, GatorFill

Saline Solution Enriched

Saline Rinse Solution DEVICE

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

Also known as: LacriPure, ScleralFil

Saline Rinse Solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Andre Vision and Device Research

West Linn, Oregon, 97068, United States

Location

Study Officials

• Bret Andre, MS, ABOe

  AVD Research

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Randomized, Double-Masked
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: March 30, 2018
• First Posted: May 16, 2018
• Study Start: April 9, 2018
• Primary Completion: December 15, 2018
• Study Completion: December 15, 2018
• Last Updated: January 27, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)