Ignite Creation Date:
2024-10-25 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06537349
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
Effects of 3 Diquafosol on Tear Film and Vision-related Quality of Life in Orthokeratology Lens Related Dry Eye
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of 3 Diquafosol on Tear Film and Vision-related Quality of Life in Orthokeratology Lens Related Dry Eye
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Investigate the effect of 3 Diquafosol on tear film and vision-related quality of life in dry eye patients wearing orthokeratology lensesOK lens and to provide reference for clinical treatmentThis prospective open label study will include 60 eyes of 30 OK lens related dry eye patientsParticipants will receive 3 Diquafosol ophthalmic solution The dosage for both drugs will be one drop six times per day for 4 weeks Pediatric Refractive Error ProfiletearPREP tear film lipid layer TFLLnon-invasive breakup time NITBUT corneoconjunctival staining score CS tear meniscus height TMH objective visual qualityocular surface disease index OSDI will be assessed and compared at baseline day-14 and day-28
Detailed Description:
Keratoplasty is gaining popularity worldwide as a method of controlling myopia progression Several clinical studies have shown that overnight wear of Orthokeratology lenses OK is an effective method of slowing myopia progression in adolescentsHowever wearing corneal contact lenses tends to interfere with tear homeostasis which may lead to ocular discomfort dryness and ocular surface disorders More than 50 of contact lens wearers report symptoms of dry eyeProlonged contact with the cornea can have an effect on the corneal layerWith the rapid increase in the use of OK lenses worldwide potential complications have become a major concern for parents Potential complications include keratitis and corneal epithelial damage In addition overnight OK lens wear has been associated with decreased tear production and reduced tear film stability Recently a four-week study by Carracedo et al demonstrated that OK lens wear did not significantly change fluorescein-stained tear film breakup time or Schirmers test I results but subjects had increased dry eye symptoms one month after wear Decrease in cupped cell density
Diquafosol Ophthalmic Solution DQS is a potent purinergic P2Y2 receptor agonist a stabilized synthetic derivative of the naturally-occurring nucleotide uridine 5-triphosphate it stimulates the secretion of mucin and tears by conjunctival cup cells and conjunctival epithelial cells Several studies have shown that Diquafosol sodium is effective in the treatment of dry eye In addition some studies have shown that Diquafosol sodium eye drops have significantly alleviated dry eye symptoms and improved ocular surface parameters in children wearing keratomileusis lenses at night However the available research lacks the ability of the DQS to assess the effect of DQS on visual acuity and quality of life improvement in patients with dry eye after wearing OK lenses The results would inform clinicians to improve comfort and compliance with keratoplasty lenses in adolescents
Diquafosol Ophthalmic Solution DQS is a potent purinergic P2Y2 receptor agonist a stabilized synthetic derivative of the naturally-occurring nucleotide uridine 5-triphosphate it stimulates the secretion of mucin and tears by conjunctival cup cells and conjunctival epithelial cells Several studies have shown that Diquafosol sodium is effective in the treatment of dry eye In addition some studies have shown that Diquafosol sodium eye drops have significantly alleviated dry eye symptoms and improved ocular surface parameters in children wearing keratomileusis lenses at night However the available research lacks the ability of the DQS to assess the effect of DQS on visual acuity and quality of life improvement in patients with dry eye after wearing OK lenses The results would inform clinicians to improve comfort and compliance with keratoplasty lenses in adolescents
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None