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

Not Applicable

Completed

• Conditions: Debris in Post Lens Tear Reservoir; Contact Lens Complication
• Interventions: Device: Saline Rinse Solution; Device: Saline Solution Enriched

• Registration Number: NCT03525704
• Lead Sponsor: Contamac Ltd

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-03-30
• Study Start: 2018-04-09
• Study First Submitted QC: 2018-05-03
• Study First Posted: 2018-05-16
• Primary Completion: 2018-12-15
• Study Completion: 2018-12-15
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-25
• Last Update Posted: 2021-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Saline Rinse Solution	Saline Rinse Solution	Saline Solution .9% NaCL
Saline Solution Enriched	Saline Solution Enriched	Saline Solution enriched with electrolytes and PH balanced to mimic normal tears

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Visual Acuity	1 Month	Visual acuity (in units of Logmar) is evaluated with subject wearing habitual contact lenses.
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.

Trial Locations

Locations (1)

Andre Vision and Device Research; 🇺🇸 West Linn, Oregon, United States