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

C

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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