Efficacy and Safety of Ocudox Lid Wipes Compared to Traditional Lid Cleaning

NCT03763006 | Completed Phase 1

• 2 other identifiers: R1451/34/20172017/2387
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The use of povidone iodine solution for prophylaxis of endophthalmitis is well established for intraocular procedures like cataract surgery and for injections of anti-VEGF agents for retinal diseases such as age-related macular degeneration. Unfortunately iodine is unfriendly to the ocular surface, and when repeated often enough (some patients require up to monthly injections of anti-VEGF agents for the entire year), corneal epitheliopathy and secondary dry eye results. Unfortunately, there is no good alternative to cleaning patient's eyelid at the moment. Ocudox is a relatively new antibacterial product (spraying on eyelid wipe) which contains Neutrox (pure hypochlorous acid) that kills many microbes, but remain very friendly and non-toxic for the ocular surface.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• SPEED Questionnaire

  To compare the frequency and severity of dry eye symptoms at baseline and after 21 days

  21 days

Study Arms (2)

Ocudox lid wiped

EXPERIMENTAL

Procedure: Eyelid cleaning

Povidone Iodine

ACTIVE COMPARATOR

Procedure: Eyelid cleaning

Interventions

Eyelid cleaning PROCEDURE

This is a pure hypochlorous acid that kills many microbes, but remain very friendly and non-toxic for the ocular surface.

Ocudox lid wiped; Povidone Iodine

Eligibility Criteria

• Age: 50 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must be 50 to 60 years old with Meibomian Gland Dysfunction (MGD)

You may not qualify if:

• Willing to perform all eye examinations in this study
• Participants diagnosed with diabetes
• No recent eye surgery or eye procedure within 1 month
• Participants who are unsuitable for Oculus K5M recording such as musculoskeletal problems
• Participants who are unable to tolerate Oculus K5M recording machine
• Is pregnant, lactating or planning a pregnancy
• Any other specified reason as determined by clinical investigator

Sponsors & Collaborators

• Singapore National Eye Centre: lead

Study Sites (1)

Singapore Eye Research Institute

Singapore, 169856, Singapore

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Louis Tong, PhD

  Singapore Eye Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Investigator will be masked
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician-Scientist, Senior Consultant

Model Details: Ocudox lid wipes

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 4, 2018
• Study Start: October 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: May 13, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)