An interventional study of 3% Diquafosol tetrasodium in Dry Eye, sponsored by He Eye Hospital. Not yet recruiting. Open to participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-08-12.
Sponsored by He Eye Hospital · Not applicable, Interventional, and Treatment
Investigate the effect of 3% Diquafosol on tear film and vision-related quality of life in dry eye patients wearing orthokeratology lenses(OK lens), and to provide reference for clinical treatment.This prospective, open label study will include 60 eyes of 30 OK lens related dry eye patients.Participants 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 Profiletear(PREP), tear film lipid layer (TFLL),non-invasive breakup time (NITBUT), corneoconjunctival staining score (CS), tear meniscus height (TMH), objective visual quality,ocular surface disease index (OSDI) will be assessed and compared at baseline, day-14, and day-28
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 adolescents.However, 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 eye.Prolonged contact with the cornea can have an effect on the corneal layer.With 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 Schirmer's 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.
1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →He Eye Hospital is the lead sponsor of 31 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
Participants in DQS group will be administered one drop of 3% DQS (Diquas, Santen Pharmaceutical Co.,Ltd., Osaka, Japan) six times per day for 4 weeks
Drug: 3% Diquafosol tetrasodium
3% Diquafosol tetrasodium eye drops will be used to assess its usefulness in OK lens related dry eye
Also known as: Diquas
Pediatric Refractive Error Profile(PREP) questionnaire score
Specifically to assess children's vision related quality of life, a total of 26 problem, original score for each from 5 points (positive) to 1 (negative), and then the original score for each minus 1 multiplied by 25, from 100 points (life quality) to 0 rating (poor quality of life), the average score for all 26 PREP problem of. "Strongly disagree" corresponds to 5 points when the statement is reversed.
Time frame: Day-0 (baseline), 2-weeks, 4-weeks
Non-invasive tear break-up time
Changes in non-invasive initial tear film breaking time will be assessed using the Keratograph 5M (Oculus, Germany) topographer. Three sequentially readings will be captured, and the median value will be included in the final analysis. The median value will be recorded.
Time frame: Day-0 (baseline), 2-weeks, 4-weeks
Tear Film Lipid Layer
Tear Film Lipid Layer interferometry will be assessed using DR-1 (Kowa, Nagoya, Japan).
Time frame: Day-0 (baseline), 2-weeks, 4-weeks
Conjunctivocorneal staining grade
Using fluorescein sodium solution or fluorescein sodium test paper to contact the lower eyelid margin, corneal and conjunctival epithelial defects under the cobalt blue light of the slit lamp microscope showed different morphology, such as green spots, erosion, lamellar defects, ulcers and so on. The following categories: according to the severity of the symptoms can be mild, slit lamp microscope check no obvious signs of ocular surface damage (corneal fluorescein staining point \< 5); Moderate: the extent of corneal damage under the slit lamp microscope did not exceed 2 quadrants and (or) the number of corneal fluorescein staining spots was \>5 and \<30. Severe: the range of corneal damage was 2 quadrants or more and (or) the corneal fluorescent staining spots were more than 30. The fluorescein staining spots in the cornea fused into thick spots, sheets or with filaments.
Time frame: Day-0 (baseline), 2-weeks, 4-weeks
Tear meniscus height
Changes in TMH will be assessed using the Keratograph 5M (Oculus, Germany) topographer. Three sequentially readings will be captured, and the median value will be included in the final analysis. The median value will be recorded.
Time frame: Day-0 (baseline), 2-weeks, 4-weeks
Ocular Surface Disease Index(OSDI) questionnaire score
the Chinese language-validated OSDI, which is a questionnaire consisting of 12 questions for evaluating the effects of dry eye syndrome on vision, ocular symptoms, and any condition associated with DED, will be used. Te patient will answer each question on a scale ranging from 0 to 4, with 0 indicating "none of the time" and 4 indicating "all of the time." If a certain question is deemed irrelevant, it will be marked as "not applicable (N/A)" and excluded from the analysis. The OSDI total score is calculated according to the proprietary formula proposed by the authors of the original OSDI. The scale ranges from 0 to 100, with higher scores representing more severe cases of DED.
Time frame: Day-0 (baseline), 2-weeks, 4-weeks
Objective visual quality assessment
Using SCHWIND SIRIUS eyes analyzer objective visual quality assessment, including: total higher-order aberrations, spherical aberration, coma makes, clover, and RMS values etc..
Time frame: Day-0 (baseline), 2-weeks, 4-weeks
No study locations are listed for this record.
Plan to share: No
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He Eye Hospital