Contact Lens Complication, Debris in Post Lens Tear Reservoir
Conditions
Keywords
Fogging, Insertion Solutions, RGP, Scleral, Contact Lenses
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.
Interventions
DEVICESaline Solution Enriched
Sterile single dose, Preservative Free, PH Balanced, Enriched with IONs rinsing and Insertion Solution
DEVICESaline Rinse Solution
sterile unit dose non-preserved, 0.9% NaCl (normal saline) solution i
Sponsors
Andre Vision and Device Research
The Contact Lens Center at Optique
Premiere Vision Group
Havasu Eye Center
Contamac Ltd
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Randomized, Double-Masked
Intervention model description
One-month, approximately 36 subjects enrolled (\ 12/site), randomized, double-masked crossover trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Visual Acuity | 1 Month | Visual acuity (in units of Logmar) is evaluated with subject wearing habitual contact lenses. |
Countries
United States
Outcome results
None listed