Contact Lens Discomfort Clinical Trial
Official title:
The Effect and Duration of Efficacy of Eyelid Margin Debridement on Signs and Secretions of Eyelids, Tear Film and Discomfort in Contact Lens Wearers
Verified date | March 2020 |
Source | The University of New South Wales |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 42 |
Est. completion date | February 1, 2018 |
Est. primary completion date | January 1, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Australia | University of New South Wales | Kensington | New South Wales |
Lead Sponsor | Collaborator |
---|---|
The University of New South Wales |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Discomfort Rating - CLDEQ-8 Questionnaire | Discomfort will be measured using the CLDEQ-8 questionnaire that involves questions about participants' experience of discomfort. This will be employed on all the study visits in the clinic. | 5 minutes | |
Secondary | End of the Day Discomfort Rating | End of the day discomfort will be assessed using a visual analog scale, where questions will be posed to participants about their level of comfort with contact lens wear at a specific time of day. This questionnaire will be a web-based survey, sent in the form of an email on the day before the baseline visit, and day 4, 9, 14, 19 and 24 from baseline visit. | 30 minutes | |
Secondary | Tear Analysis | Change in tear lipids at day 4, 9, 14, 19 and 24 compared to baseline | 15 minutes | |
Secondary | Meibum Analysis | Change in meibum lipids at day 4, 9, 14, 19 and 24 compared to baseline. | 10 minutes | |
Secondary | Meibography | Meibomian gland (glands in eyelids) morphology will be compared at day 4, 9, 14, 19 and 24 compared to baseline. | 5 minutes | |
Secondary | Demodex Infestation | Highly magnified images of eyelids will be captured with a microscope to count the number of Demodex on eyelids. these images will be compared at day 4, 9, 14, 19 and 24 compared to baseline. | 15 minutes | |
Secondary | Lid Microbiota | Change in colony forming units of cultivable eyelid microbiota will be compared at day 4, 9, 14, 19 and 24 compared to baseline. | 5 minutes | |
Secondary | LipiView Interferometry | The change in absolute thickness of the tear film lipid layer will be compared at day 4, 9, 14, 19 and 24 compared to baseline. | 10 minutes | |
Secondary | Lid Sensitivity | Change in eyelid sensitivity assessed using Cochet Bonnet aesthesiometer will be compared at day 4, 9, 14, 19 and 24 compared to baseline. | 5 minutes | |
Secondary | Tear Osmolarity | Change in tear osmolarity using TearLab osmometer will be compared at day 4, 9, 14, 19 and 24 compared to baseline. | 5 minutes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03682809 -
Evaluation of Systane Complete for the Treatment of Contact Lens Discomfort
|
Phase 4 | |
Completed |
NCT05416528 -
Chinese Translation and Validation of the 8-item Contact Lens Dry Eye Questionnaire (CLDEQ-8)
|
||
Completed |
NCT05548491 -
Safety, Tolerability and Pharmacodynamics of AZR-MD-001 in Contact Lens Discomfort (CLD)
|
Phase 2 | |
Active, not recruiting |
NCT03652337 -
Meibomian Gland Dysfunction Management
|
N/A | |
Not yet recruiting |
NCT05801991 -
Neurolens and Contact Lens Discomfort
|
N/A | |
Completed |
NCT03994406 -
Prolongation of Contact Lens Comfortable Wear Duration by CLM2 Topical Gel
|
Phase 2 | |
Completed |
NCT02848222 -
Pilot Study for Investigating the Effect of the Bruder Eye Hydrating Compress on Contact Lens Discomfort in Contact Lens Wearers
|
N/A | |
Completed |
NCT03686878 -
Lifitegrast 5% Ophthalmic Solution and Contact Lens Dryness
|
Phase 4 |