Effect of Contact Lens With Alginic Acid in Dry Eye Patients
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|ClinicalTrials.gov Identifier: NCT01918410|
Recruitment Status : Completed
First Posted : August 7, 2013
Last Update Posted : May 20, 2015
|Condition or disease||Intervention/treatment||Phase|
|Dry Eyes||Device: Contact Lens with alginic acid Device: Contact Lens without alginic acid||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||To Evaluate Effect of Contact Lens With Alginic Acid (7 Days) in Patients With Dry Eye|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
|Active Comparator: Contact Lens with alginic acid||
Device: Contact Lens with alginic acid
Worn for 7 days, at least 8 hours a day
|Placebo Comparator: Contact lens without alginic acid||
Device: Contact Lens without alginic acid
Worn for 7 days, at least 8 hours a day
- • Difference of Visual Analogue Scale (VAS) for the ocular discomfort between control and treatment group. [ Time Frame: 7 days ]
A VAS will be applied to evaluate dry eye symptoms as described by Schaumberg et al. (Schaumberg, Gulati et al. 2007). The scores will be recorded separately for frequency and severity of dry eye symptoms. The patient will be asked to check a point on a 100-mm line that corresponds to the degree of the symptom. The location of the mark made by the patient for each question will be measured in mm from the left hand side of the 100 mm line and recorded in mm. For the follow up visits, which measured the distance between the mark made by the patient and the central anchor, a negative value will be recorded if left of the anchor and a positive value if right of the anchor.
A global score will be calculated by multiplying the frequency score by the severity score and taking the square root of the result (to transform back to the original scale).
- Tear lipid layer thickness measurements of LipiView [ Time Frame: 7 days ]During the measurement of each eye, the participants place their chins on a chin rest and look at a single white light source for 30 seconds. During this period, participants are encouraged to blink freely at a comfortable rate which the assessor measures the LLT.
- Schirmers I reading [ Time Frame: 7 days ]
This will be done with the standard strips currently used at SERI (5 mm wide with a notch for folding) (Sno strips, Bausch&Lomb, France) without anaesthetic. The strips will be positioned over the inferior temporal half of the lower lid margin in both eyes at the same time.
The study participant will be asked to close their eyes during the test. Any excessive irritation signs or reflex tearing will be noted. The extent of the wetting in each strip will be recorded after 5 minutes of testing. The strip will be collected and stored in 1.5ml eppendorf tubes at -80˚C until further tear lipid and protein analysis.
- Tear break up time (TBUT) [ Time Frame: 7 days ]Keratograph 5M will be used to perform the non invasive tear break up time. Patient will sit comfortably in front of the instrument and blink freely while fixing on a target directly ahead. Once the patient is ready, patient will be instructed to blink once and refrain from blinking. Keratograph 5M is fully automated and it will capture any break or distortion in the image and the time of the break will be noted. Three readings will be taken for each eye to get the average value.
- Corneal flourescein staining [ Time Frame: 7 days ]Routine anterior segment assessment with a slit lamp microscope will be carried out to evaluate corneal health and clinical signs. Assessment of positive fluorescein staining on cornea and conjunctiva will be assessed. A scoring system will be applied as adapted by Bron A, Evans VE, Smith JA. (2003).The grading scheme depends on the intensity and the area of the staining for each panel with scale from 0 to 5. Briefly, there will be corneal zone and exposed interpalpebral conjunctival regions as shown in Figure 2. The staining increases by 1 log unit for the first 2 panel and ½ unit log for the subsequent 3 panel.
- Tear proteomic analysis [ Time Frame: 7 days ]The strip will be collected and stored in 1.5ml eppendorf tubes at -80˚C until further tear lipid and protein analysis.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01918410
|Singapore National Eye Centre/ Singapore Eye Research Institute|
|Singapore, Singapore, 168751|