Observation of patients with dry eyes treated with HYLO NIGHT® eye ointment

Not Applicable

• Conditions: Dry eye disease; Eye Diseases; Other disorders of lacrimal gland

• Registration Number: ISRCTN94067011
• Lead Sponsor: RSAPHARM (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-08-23
• Last Update Posted: 8 January 2024
• Study Completion: 2024-12-19

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

1. Male and female patients, at least 18 years of age
2. Patients with binocular moderate dry eyes, defined as follows:
2.1. Non-invasive tear breakup time (NIBUT) =9 sec
2.2. Ocular surface staining grade is between =4 and = 9 on the 15-point Oxford Grading Scale
3. Subjective complaints in terms of a moderately dry eye (frequency, severity, foreign body sensation, dryness, burning, tearing, tired eyes) for at least 3 months:
3.1. VAS =3/10 (each for frequency, severity)
3.2. OSDI =15
4. Corneal sensitivity =5
5. Stable therapy (systemic) =4 weeks
6. Patient's ability to provide consent
7. The patient is able and willing to meet the requirements of the protocol

Exclusion Criteria

1. Dry eye caused by systemic disease, concomitant pharmacological therapy, or malignancy
2. Other therapeutic interventions at the discretion of the investigator, e.g. mechanical cleaning of the eyelid margins, LipiflowTM, IPL. Maskin probing, administration of tear substitutes containing lipids, water-free or containing preservatives
3. Ocular surgeries within the last 3 months
4. Lid misalignment and/or lagophthalmos
5. Use of punctum plugs within the last 3 months
6. Contact lens wearers
7. Use of other pharmacological ophthalmic drugs within the last 4 weeks
8. Hypersensitivity to any of the ingredients
9. The patient is a pregnant or breastfeeding woman
10. The patient is a woman of childbearing potential without regular and correct use of a contraceptive method with a failure rate <1% (e.g., sexual abstinence, estrogen- and progestin-containing contraceptives, vasectomy, intrauterine device (IUD) with hormones)
11. Simultaneous participation in a clinical trial or another clinical trial within the last 4 weeks
12. Previous participation in this clinical investigation or the patient is the investigator himself or a member of the staff involved in the clinical investigation
13. Inability to understand the language and/or content of the written patient information

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
on-invasive Tear Break Up Time (NIBUT) measured using a keratograph at baseline and day 28±3

Secondary Outcome Measures

Name	Time	Method
1. Subjective complaints assessed with questionnaire (visual analogue score [VAS], Ocular Surface Disease Index [OSDI]) at baseline, day 7±2 and day 28±3<br>2. Visual acuity measured by line read in decimal numbers with correction at baseline, day 7±2 and day 28±3<br>3. Conjunctiva (conjunctival hyperemia, lid-parallel conjunctival folds [LIPCOF], conjunctival staining with lissamine greenand) examined using slit lamp at baseline, day 7±2 and day 28±3<br>4. Staining of the cornea with fluorescein examined using a slit lamp at baseline, day 7±2 and day 28±3<br>5. Eyelid margins examined using slit lamp at baseline, day 7±2 and day 28±3<br>6. Intraocular pressure measured using non-contact tonometry at baseline<br>7. Corneal sensitivity measured using an esthesiometer at baseline<br>8. Tolerability assessed by questioning the patient on day 7±2 and day 28±3<br>9. Effectiveness and tolerability assessed by questioning the investigator on day 28±3