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

Contact Lens Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03525704
• Other study ID #: AVDR 2018-01 v1.2
• Status: Completed
• Phase: N/A
• Start date: April 9, 2018
• Est. completion date: December 15, 2018

Study information

• Verified date: January 2021
• Source: Contamac Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 15, 2018
• Est. primary completion date: December 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Contact Lens Complication
• Debris in Post Lens Tear Reservoir

Intervention

Device:
• Saline Solution Enriched
Sterile single dose, Preservative Free, PH Balanced, Enriched with IONs rinsing and Insertion Solution
• Saline Rinse Solution
sterile unit dose non-preserved, 0.9% NaCl (normal saline) solution i

Locations

Country	Name	City	State
United States	Andre Vision and Device Research	West Linn	Oregon

Sponsors (5)

Lead Sponsor	Collaborator
Contamac Ltd	Andre Vision and Device Research, Havasu Eye Center, Premiere Vision Group, The Contact Lens Center at Optique

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Biomicroscopy Findings	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.	1 Month
Secondary	Visual Acuity	Visual acuity (in units of Logmar) is evaluated with subject wearing habitual contact lenses.	1 Month