Contact Lens ComplicationNCT03525704
Evaluation of Contact Lens Saline Solutions With Scleral GP Contact Lens Wearers Experiencing Fogging
A study testing Saline Solution Enriched and Saline Rinse Solution in people with Contact Lens Complication and Debris in Post Lens Tear Reservoir, run by Contamac Ltd at 1 site in United States.
Trial summary
Evaluation of saline solutions used with scleral rigid gas permeable contact lens wearers experiencing debris in the post lens tear reservoir Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Contact Lens Complication, Debris in Post Lens Tear Reservoir
- What is being tested?
- Saline Solution Enriched and Saline Rinse Solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2018to 15 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Andre Vision and Device Research
West Linn, Oregon, 97068
About this study
Evaluation of saline solutions used with scleral rigid gas permeable contact lens wearers experiencing debris in the post lens tear reservoir
Read the 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.
- Being tested
- Saline Solution Enriched, Saline Rinse Solution
- Keywords
- Fogging, Insertion Solutions, RGP, Scleral, Contact Lenses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline Solution EnrichedDevice
Also called NutriFill, GatorFill
Sterile single dose, Preservative Free, PH Balanced, Enriched with IONs rinsing and Insertion Solution
Saline Rinse SolutionDevice
Also called LacriPure, ScleralFil
sterile unit dose non-preserved, 0.9% NaCl (normal saline) solution i
| Study group | Role | What they receive |
|---|---|---|
| Saline Solution Enriched | Experimental | Saline Solution enriched with electrolytes and PH balanced to mimic normal tears Receives: Device: Saline Solution Enriched |
| Saline Rinse Solution | Active comparator | Saline Solution .9% NaCL Receives: Device: Saline Rinse Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 Month
Secondary outcomes (2)
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.
Measured: 1 Month
Visual Acuity
Visual acuity (in units of Logmar) is evaluated with subject wearing habitual contact lenses.
Measured: 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2018
- Study start9 Apr 2018
- Primary completion15 Dec 2018
- Study completion15 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contact Lens ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- One-month, approximately 36 subjects enrolled (\~12/site), randomized, double-masked crossover trial.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Contamac Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Andre Vision and Device Research, The Contact Lens Center at Optique, Premiere Vision Group, Havasu Eye Center
- Responsible party
- Sponsor
- Investigators
- Bret Andre, MS, ABOe, Study director, AVD Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03525704
- Sponsor's protocol ID
- AVDR 2018-01 v1.2
- Status last verified
- Jan 2021
- First submitted
- 30 Mar 2018
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Contact Lens Saline Solutions With Scleral GP Contact Lens Wearers Experiencing Fogging
- ClinicalTrials.gov ID
- NCT03525704
- Acronym / sponsor ID
- AVDR 2018-01 v1.2
- Keywords
- Fogging, Insertion Solutions, RGP, Scleral, Contact Lenses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Contamac LtdIndustry (pharma, biotech, devices)
- Collaborators
- Andre Vision and Device Research, The Contact Lens Center at Optique, Premiere Vision Group, Havasu Eye Center
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- 15 Dec 2018 (actual)
- First posted
- 16 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- One-month, approximately 36 subjects enrolled (~12/site), randomized, double-masked crossover trial.
| Arm | Type | Receives |
|---|---|---|
| Saline Solution Enriched | Experimental | Device: Saline Solution EnrichedSaline Solution enriched with electrolytes and PH balanced to mimic normal tears |
| Saline Rinse Solution | Active comparator | Device: Saline Rinse SolutionSaline Solution .9% NaCL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saline Solution EnrichedAlso: NutriFill, GatorFillSterile single dose, Preservative Free, PH Balanced, Enriched with IONs rinsing and Insertion Solution | Device | Saline Solution Enriched |
| Saline Rinse SolutionAlso: LacriPure, ScleralFilsterile unit dose non-preserved, 0.9% NaCl (normal saline) solution i | Device | Saline Rinse Solution |
Primary outcome
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)
2 secondary outcomes
Biomicroscopy Findings
Time frame: 1 Month
Visual Acuity
Time frame: 1 Month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bret Andre, MS, ABOe study director
AVD Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saline Solution Enriched and Saline Rinse Solution in people with Contact Lens Complication and Debris in Post Lens Tear Reservoir, run by Contamac Ltd at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Subjective Symptoms and Wear Time Survey (time frame: 1 Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021.