Trials Sponsors Conditions Drugs Pricing

Conditions

Contact Lens Complication Debris in Post Lens Tear Reservoir

Keywords

FoggingInsertion SolutionsRGPScleralContact 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 EnrichedDevice

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

Also known as: NutriFill, GatorFill

Saline Solution Enriched

Saline Rinse SolutionDevice

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

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (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.

Sponsors & Collaborators

The Contact Lens Center at Optique
Type not reportedcollaborator
Premiere Vision Group
Type not reportedcollaborator
Havasu Eye Center

Study Sites (1)

Andre Vision and Device Research

West Linn, Oregon, 97068, United States

Study Officials

Bret Andre, MS, ABOe
AVD Research
STUDY DIRECTOR

Enrollment

36 participants (actual enrollment reported by the registry).

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

Study Record Dates

First Submitted

March 30, 2018

First Posted

May 16, 2018

Study Start

April 9, 2018

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Saline Solution Enriched

Saline Rinse Solution

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Saline Solution Enriched

Saline Rinse Solution

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations