Effect of Contact Lens With Alginic Acid in Dry Eye Patients
To Evaluate Effect of Contact Lens With Alginic Acid (7 Days) in Patients With Dry Eye
1 other identifier
interventional
30
1 country
1
Brief Summary
Contact lens induced dry eyes leads to lens intolerance and discontinuation. Incidence of dry eye in contact lens wearer is significantly higher in Asian population compared to other ethnic group considering Asian has lower tear break up time. Disruptions of tear integrity in contact lens wearer will further exacerbate the condition. Factors for successful contact lens fitting derive from the biocompatibility of lens material, lens design and stability of tear film in front of the contact lens. This study aim to investigate the efficacy of a novel daily disposable contact lens with zwitterionic material that contains alginic acid which act as a moisturizing agent. The improved lens material may likely improve the comfort and treat symptomatic wearers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2013
CompletedFirst Posted
Study publicly available on registry
August 7, 2013
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedMay 20, 2015
June 1, 2014
10 months
August 6, 2013
May 18, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
• Difference of Visual Analogue Scale (VAS) for the ocular discomfort between control and treatment group.
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).
7 days
Secondary Outcomes (5)
Tear lipid layer thickness measurements of LipiView
7 days
Schirmers I reading
7 days
Tear break up time (TBUT)
7 days
Corneal flourescein staining
7 days
Tear proteomic analysis
7 days
Study Arms (2)
Contact Lens with alginic acid
ACTIVE COMPARATORContact lens without alginic acid
PLACEBO COMPARATORInterventions
Worn for 7 days, at least 8 hours a day
Worn for 7 days, at least 8 hours a day
Eligibility Criteria
You may qualify if:
- Age of 21 years old and above and has full legal capacity to volunteer
- Soft contact lens wearer
- Willing to wear study lenses for at least 8 hours/day for 7 days
- Reports dryness symptoms with contact lens wear on questionnaire.
- Schirmers I with no aneasthesia of less than 10mm
- Is willing and able to follow instructions and maintain the appointment schedule
- Vision correctable to 6/9 (Snellen) or better in each eye at distance with study lenses at baseline
- Has a contact lens prescription between +4.00 to -6.00D with astigmatism \<=-1.00
You may not qualify if:
- Requires concurrent ocular medication
- Is participating in any concurrent clinical or research study
- Has used Restasis® in the last 3 months
- Wears punctal plugs fitted in the last 1 month
- Any systemic illness which would contraindicate lens wear
- Diabetic
- Has had an eye injury or surgery within the last 3 months
- Keratoconus or other corneal irregularity
- Has had ocular surgery done within the previous 3 months
- Active ocular surface conditions such as infection or pterygium that may affect tear film stability.
- Is pregnant, lactating or planning a pregnancy
- Any other specified reason as determined by clinical investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Louis Tonglead
- Singapore Eye Research Institutecollaborator
- SEED Company Pte Ltdcollaborator
Study Sites (1)
Singapore National Eye Centre/ Singapore Eye Research Institute
Singapore, Singapore, 168751, Singapore
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinician-Scientist, Senior Consultant
Study Record Dates
First Submitted
August 6, 2013
First Posted
August 7, 2013
Study Start
February 1, 2014
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
May 20, 2015
Record last verified: 2014-06