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

Contamac

Status: Completed

Conditions: Debris in Post Lens Tear Reservoir; Contact Lens Complication

Treatments: Device: Saline Rinse Solution; Device: Saline Solution Enriched

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03525704

AVDR 2018-01 v1.2

Details and patient eligibility

About

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

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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36 participants in 2 patient groups

Saline Solution Enriched

Experimental group

Description:

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

Treatment:

Device: Saline Solution Enriched

Saline Rinse Solution

Active Comparator group

Description:

Saline Solution .9% NaCL

Treatment:

Device: Saline Rinse Solution