Evaluation of Contact Lens Saline Solutions With Scleral GP Contact Lens Wearers Experiencing Fogging
January 25, 2021 updated by: Contamac Ltd
Evaluation of saline solutions used with scleral rigid gas permeable contact lens wearers experiencing debris in the post lens tear reservoir
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oregon
-
West Linn, Oregon, United States, 97068
- Andre Vision and Device Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Saline Solution Enriched
Saline Solution enriched with electrolytes and PH balanced to mimic normal tears
|
Sterile single dose, Preservative Free, PH Balanced, Enriched with IONs rinsing and Insertion Solution
Other Names:
|
|
Active Comparator: Saline Rinse Solution
Saline Solution .9% NaCL
|
sterile unit dose non-preserved, 0.9% NaCl (normal saline) solution i
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Subjective Symptoms and Wear Time Survey
Time Frame: 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)
|
1 Month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Biomicroscopy Findings
Time Frame: 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.
|
1 Month
|
|
Visual Acuity
Time Frame: 1 Month
|
Visual acuity (in units of Logmar) is evaluated with subject wearing habitual contact lenses.
|
1 Month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Bret Andre, MS, ABOe, AVD Research
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 9, 2018
Primary Completion (Actual)
December 15, 2018
Study Completion (Actual)
December 15, 2018
Study Registration Dates
First Submitted
March 30, 2018
First Submitted That Met QC Criteria
May 3, 2018
First Posted (Actual)
May 16, 2018
Study Record Updates
Last Update Posted (Actual)
January 27, 2021
Last Update Submitted That Met QC Criteria
January 25, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AVDR 2018-01 v1.2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.