Clinical trial on the effect of Resolvis on ocular surface diseases.

Double masked randomized clinical trial on the tolerability and efficacy of Resolvis for the treatment of the ocular surface with qualitative and quantitative changes of the tear film.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26119

Enrollment

Registered

2011-11-14

Start date

2011-11-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dry eye

Interventions

Treatment with Resolvis (bis in die = 2 times/day) for 28 days will be given at the study group (N=15). The control group (N=15) includes patients with symptoms and signs of dry eye as the treated gr

Eligibility

Inclusion criteria

Inclusion criteria: 1. Symptoms of dry eye; 2. And at least 2 of the following: A. Schirmer test or = 3.

Exclusion criteria

Exclusion criteria: 1. Glaucoma; 2. Ocular surface infections; 3. Corneal ulcer; 4. Conjunctival infections; 5. Treatment with anti-inflammatory drugs and cyclosporine in the 3 months preceding the study; 6. Surgical procedures in the 3 months preceding the study; 7. Antiglaucoma therapies; 8. Contact lens use 7 days before the study.

Design outcomes

Primary

Measure	Time frame
Increased stability of the tear film mesured by tear break-up time (BUT).	—

Secondary

Measure	Time frame
Reduced symptoms (measured by means of a specific questionnaire, ocular surface disease index), and ocular surface signs and inflammation (measured by fluorescin and lissamine green staining of the ocular surface, HLA-DR expression) after treatment of dry eye.	—

Contacts

Public ContactStefano Barabino

Viale Benedetto XV, 5

barabino@schepens.harvard.edu+39 010 35338294

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)