Application of HYLO CARE® eye drops in dry eyes after cataract surgery

Not Applicable

Completed

• Conditions: Postoperative lubricating disorders after cataract surgery; Eye Diseases

• Registration Number: ISRCTN31223901
• Lead Sponsor: RSAPHARM (Germany)

Brief Summary

2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38893624/ (added 03/07/2024)

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-06-10
• Study Start: 2023-04-17
• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

1. Male and female patients >18 years
2. Age-appropriate cataract (uni- or bilateral)
3. Standard cataract surgery is possible, according to the surgeon
4. Preoperatively subjective complaints indicating a dry eye (foreign body sensation, dryness, burning, tearing, tired eyes) for at least 3 months:
4.1. VAS =2/10
4.2. OSDI =16
4.3. Fluorescein TBUT =10 s
5. Stable therapy (topical and systemic) =4 weeks
6. Patient is willing to participate in the trial
7. Patient is willing and able to fulfil the requirements of the trial protocol

Exclusion Criteria

1. Dry eye due to systemic disease, concomitant medication, or malign conditions
2. Simultaneous preoperative use of other therapeutic ophthalmics
3. Ocular or systemic pathologies that could, according to the surgeon’s medical evaluation, have an influence on postoperative irritation (acute viral or bacterial inflammation of the conjunctiva/cornea, chronic inflammatory/infectious uveitis)
4. History of ocular surgery during the past 3 months
5. Malposition of the lids and/or lagophthalmos
6. Punctum plugs during the past 3 months
7. Contact lens wearers (no wearing of contact lenses 3 months before surgery)
8. Hypersensitivity against one of the ingredients of HYLO CARE®
9. Patient is a pregnant or breastfeeding woman
10. The patient is a woman with childbearing potential without the regular and correct use of contraception with error quote <1 % (e.g. sexual abstinence, estrogenic- and metagene-containing contraceptive, vasectomy, intrauterine pessary with hormones)
11. Concomitant participation in a clinical trial or another trial within the last 4 weeks and 4 weeks after the end of the trial
12. Earlier participation in this clinical trial or the patient being an investigator or a member of the personnel involved in this clinical trial.
13. Inability for linguistic or content comprehension of written patient information

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Tear Break-up Time (TBUT) measured in seconds rounded to 1 decimal place using a non-automated method as described by Jacobi and Cursifen 2010 from first measurement preoperatively (D0) compared to measurement on day 35 (D35) ± 5 days (= 5 weeks) postoperatively