NCT03640351

Clinical Effects of Diquas-S for Patients With Dry Eye After Cataract Surgery

Completed NA Last updated 30 September 2020

What this trial tests

NA trial testing 1. Use of preservative free diquafosol ophthalmic solution after cataract surgery in Dry Eye in 150 participants. Completed in 13 February 2019.

Timeline

15 August 2017

Primary endpoint
13 February 2019

13 February 2019

Quick facts

Lead sponsor	Yonsei University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	150
Start date	15 August 2017
Primary completion	13 February 2019
Estimated completion	13 February 2019
Sites	1 location across South Korea

Drugs / interventions tested

• 1. Use of preservative free diquafosol ophthalmic solution after cataract surgery — full drug profile →
• 2. Use of preservative containing diquafosol ophthalmic solution after cataract surgery — full drug profile →
• 3. Use of preservative free sodium hyaluronate ophthalmic solution after cataract surgery — full drug profile →

Conditions studied

• Dry Eye — all drugs for Dry Eye →
• Cataract Surgery — all drugs for Cataract Surgery →

Sponsor

Yonsei University

Who can join

20 and older, any sex, with Dry Eye or Cataract Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Today, cataract surgery has become one of the safest and most effective eye surgical procedures performed on many people through the development and development of surgical techniques and instruments. However, a significant number of patients who underwent cataract surgery still complain about postoperative symptoms, such as irritation, pain, dryness, burning sensation, and foreign body sensation. The reasons of dry eye (DE) development after cataract surgery include thermal and light toxicity from the microscope, corneal epithelial damage, and frequent irrigation of ocular surface during operation, sterilization of conjunctival sac and eyelid with chemicals, transection of the corneal nerves by corneal incision, use of topical anesthetics, and preservatives in topical eye drops. In this era of high expectation of patients and premium intraocular lenses, the postoperative discomforts cannot be accepted to many patients. Several studies have recently reported that the common cause of postoperative symptoms of the patients is DE. Furthermore, if the ocular surface is deformed due to DE syndrome after surgery, the optical quality is greatly affected which results in a decrease of the quality of vision. If the tear film becomes irregular, the higher-order aberration can change due to local irregular total radius of curvature of ocular surface and result in decreased visual acuity.

There have been many attempts to treat DE syndrome after cataract surgery. Artificial tears are commonly used for the first line treatment of postoperative DE and several studies revealed its effectiveness on management of DE symptoms and signs. The postoperative use of cyclosporine 0.05 % topical eye drop improved DE symptoms and visual quality after cataract surgery. Recently, diquafosol sodium ophthalmic solution has been used for the management of DE after cataract. Diquafosol is a dinucleotide derivative and functions as agonist to the purinergic P2Y2 receptor. Diquafosol is known to stimulate not only the mucin secretion from the goblet cells but also water secretion from conjunctival epithelial cells and accessory lacrimal glands. According to previous studies, diquafosol has been found to be very effective in treating DE after cataract and to alleviate symptoms of DE syndrome. Furthermore, several studies have shown that topical diquafosol has a better efficacy in managing DE after cataract surgery than artificial tears. The preservative free diquafosol ophthalmic solution has been released recently. The use of eye drops without preservatives has also been shown to play an important role in the treatment of DE after cataract surgery. Until now, there is no study that evaluated the effect of preservative free diquafosol ophthalmic solution. Thus the investigators try to investigate the efficacy of preservative free diquafosol ophthalmic solution compared to preservative containing diquafosol ophthalmic solution and sodium hyaluronate ophthalmic solution, which are widely used in patients with DE after cataract surgery.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effects of Preservative-free 3% Diquafosol in Patients with Pre-existing Dry Eye Disease after Cataract Surgery: A Randomized Clinical Trial.
   Jun I, Choi S, Lee GY, Choi YJ, et al · · 2019 · cited 27× · PMID 31477748 · DOI 10.1038/s41598-019-49159-0