Compare the Clinical Efficacy of 3% Diquafosol and 0.1% Hyaluronic Acid in Patients With Dry Eye After LASIK

NCT07097922 | Not Yet Recruiting

• 1 other identifier: LASIK2025
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief Summary

The prevalence of refractive ametropia is rising year by year. Refractive surgery has become the main approach for adults to correct refractive ametropia, and postoperative complications have aroused extensive attention from clinicians. Dry eye after refractive surgery is one of the postoperative complications, which is an important cause of affecting the postoperative visual quality and satisfaction of patients. It was reported that 3% diquafosol (DQS) and 0.1% hyaluronic acid (HA) can relieve dry eye symptoms. This study aims to compare the efficacy of 3% DQS and 0.1% HA in treating dry eye after LASIK

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• Non-invasive tear break-up time (NITBUT)

  The Keratograph 5M (Oculus, Germany) topographer will assess non-invasive tear breakup time. Three sequential readings will be captured, and the median value will be included in the final analysis. The median value will be recorded

  Baseline, week 4, week 12 and week 24

Secondary Outcomes (9)

• Conjunctivocorneal staining (CS)

  Baseline, week 4, week 12 and week 24

• Tear film lipid layer (TFLL) score

  Baseline, week 4, week 12 and week 24

• Corneal Sensitivity Score

  Baseline, week 4, week 12 and week 24

• Tear meniscus height (TMH)

  Baseline, week 4, week 12 and week 24

• Conjunctival hyperemia (RS score)

  Baseline, week 4, week 12 and week 24

Study Arms (2)

Study group

EXPERIMENTAL

dry eye patients after LASIK

Drug: 3% Diquafosol Sodium Eye Drops

Control group

OTHER

dry eye patients after LASIK

Drug: 0.1% hyaluronic acid

Interventions

3% Diquafosol Sodium Eye Drops DRUG

3% Diquafosol Sodium Eye Drops were instilled into the inferior conjunctival vault of both eyes

Study group

0.1% hyaluronic acid DRUG

0.1% sodium hyaluronate eye drops were instillation into the inferior conjunctival vault of both eyes

Control group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• History of LASIK surgery for more than six months
• Confirmed dry eye: patients complained of one of the subjective symptoms of ocular dryness, foreign body sensation, burning sensation, fatigue, discomfort, redness of the eyes, and fluctuating visual acuity; as well as (a) OSDI questionnaire score of ≥13 and (b) non-invasive tear break-up time (NITBUT) of \<10 s or (c) ocular surface staining assessed in \>5 corneal patches/greater than 9 conjunctival patches
• Participants were able to co-operate with the use of eye drops as required, complete the examination, and return to the hospital within the specified time for follow-up examinations to complete the follow-up visit.

You may not qualify if:

• Suspected of having keratoconus, a definite diagnosis of keratoconus or another type of corneal dilatation disease.
• There is active inflammation or symptoms of infection in the eye
• There are serious lesions in the accessory structures of the eye, such as defects or deformations of the eyelids
• Patients with Connective tissue diseases and Autoimmune disorders (e.g., SLE, RA)

Sponsors & Collaborators

• He Eye Hospital: lead

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 1, 2025
• Study Start: August 1, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: August 1, 2025

Record last verified: 2025-07