Status:
COMPLETED
Effect of Contact Lens With Alginic Acid in Dry Eye Patients
Lead Sponsor:
Louis Tong
Collaborating Sponsors:
Singapore Eye Research Institute
SEED Company Pte Ltd
Conditions:
Dry Eyes
Eligibility:
All Genders
21-90 years
Phase:
NA
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 cons...
Detailed Description
This study will be conducted in compliance with the protocol, SGCP and the applicable regulatory requirements. Dry eye is a condition that affects 5-35% of the population.1 Common symptoms of this co...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01918410
Start Date
February 1 2014
End Date
December 1 2014
Last Update
May 20 2015
Active Locations (1)
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1
Singapore National Eye Centre/ Singapore Eye Research Institute
Singapore, Singapore, Singapore, 168751