The Effect of Eyelid Margin Debridement on Contact Lens Discomfort

NCT03311204 | Completed DMC

• 1 other identifier: UNewSouthwales
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, clinical variables related to eyelids that potentially have an effect on contact lens discomfort will be investigated such as eyelid signs and secretions, eyelid sensitivity, eyelid microbiome, Demodex infestation and tear film properties. The main aim of this study is to understand the duration of efficacy of debridement of the eyelid margin and its impact on various eyelid signs (such as lid wiper epitheliopathy, lid-parallel conjunctival folds, eyelid sensitivity, meibomian gland morphology and meibum secretions, palpebral conjunctival reaction, eyelid microbiome and Demodex infestation, tear properties (both biophysical properties such as tear volume, tear meniscus height, tear evaporation, tear osmolarity and tear breakup time; and biochemical properties that are tear lipid analysis). To observe these variables, this study employs a cross-sectional design to study the effect of treatment at three instances, that is at baseline and two follow-up visits.

Conditions

Contact Lens Discomfort

Keywords

Eyelid margin; Tear Film; Debridement; Contact Lens; Ocular Discomfort

Outcome Measures

Primary Outcomes (1)

• Lid Wiper Epitheliopathy

  The eyelids will be examined using a slit lamp before and after instillation of sodium fluorescein. This stain helps to disclose changes to the eyelid surface .

  5 minutes

Secondary Outcomes (10)

• Discomfort Rating - CLDEQ-8 Questionnaire

  5 minutes

• End of the Day Discomfort Rating

  30 minutes

• Tear Analysis

  15 minutes

• Meibum Analysis

  10 minutes

• Meibography

  5 minutes

Study Arms (2)

Microblepharon Exfoliation

EXPERIMENTAL

This treatment is provided using BlephEx tool from Optimed Pty Ltd.

Device: BlephEx

Eyelid cleansing using Lid Hygenix

EXPERIMENTAL

Foam-based hypoallergenic cleanser used as a control treatment in this study.

Other: Lid Hygenix

Interventions

BlephEx DEVICE

BlephEx is an instrument that contains a hand piece used to spin a medical grade micro-sponge along the edge of eyelids and lashes that helps in removing scurf and debris from eyelids and helps in exfoliating the lids. A new micro-sponge will be used for every subject to avoid cross-contamination. This procedure lasts for 6-8 mins.

Microblepharon Exfoliation

Lid Hygenix OTHER

Foam-based hypoallergenic cleanser used to clean eyelid margins is used as a control intervention for the study.

Eyelid cleansing using Lid Hygenix

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age of 18 years or above
• Understand their rights as a research subject
• Willing and able to sign a statement of informed consent
• Normal ocular status, defined as a minimum of 20/40 visual acuity in each eye; clear corneas without scarring, opacities, or vascularization, as determined by biomicroscopic examination
• Normal external examination
• Normal puncta without punctal plugs
• Ability to cooperate with the required procedures of diagnostic agent installation, eyelid eversion, and examination.
• Contact lens wearers who have worn lenses for at least 6 months, used contact lenses for 3 weeks before the evaluation visit and used these lenses at least four times a week. These contact lens wearers will be on daily wearing modality, where the subject is supposed to wear it for at least for 6 hours, only during the day and remove the lenses during sleep.

You may not qualify if:

• Any ocular or systemic disease that might influence the tear film and especially subjects with a history of episodes of epilepsy.
• Subjects with eyelid inflammation of more than grade 2 will be excluded from the study as they need therapeutic intervention.
• All conjunctival abnormalities, including pingueculae greater than 1 mm in diameter, location closer than 2 mm to the limbus, or elevated more than 0.2 mm
• All forms of conjunctivitis, including allergic conjunctivitis
• Fluorescein corneal staining of grade 2 or more, after a single installation of non-preserved fluorescein solution followed by examination 1 minute after installation
• Current ocular infection or treatment of such infections with ocular or systemic medications
• Current use of any prescription or non-prescription ocular or systemic medications, including antihistamines
• Use of artificial tear preparations during the period 2 hours before the examination
• Use of any ocular ointment during the 3 days before the examination
• Any history of ocular surgery

Sponsors & Collaborators

• The University of New South Wales: lead

Study Sites (1)

University of New South Wales

Kensington, New South Wales, 2152, Australia

Location

Study Officials

• Mark Willcox, D Sc

  University of New South Wales

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The clinical signs are photographed and an outcomes accessor grades the clinical signs. This process ensures that there is no bias in recording the results. This method was specially chosen, due to the lack or inability to mask the treatment procedures, due to their nature of treatment.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ms

Model Details: Single-center, randomized, cross-over, open-label interventional study

Study Record Dates

• First Submitted: October 11, 2017
• First Posted: October 17, 2017
• Study Start: November 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: February 1, 2018
• Last Updated: March 20, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)