Comparison of Topical Treatment for Inflammatory Secretions of the Conjonctiva (Patients With Ocular Prostheses)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-85
SponsorAgnes
About this trial
We propose to evaluate the efficacy of treatment with Hydrocortisone and Dexamethasone (in a cross-over design) in patients with ocular prostheses and significant functional discomfort.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient aged 18 years or older;
Wearing a permanent prosthesis for more than 6 months; - Consultant in the ophthalmology department;
Modified OSDI score ≥ 20 points out of 40 ;
Affiliated with a health insurance scheme,
Disqualifiers
Treatment with eye drop(s) (other than artificial tears or antiseptic) < 1 month;
Concomitant treatment with CYP3A inhibitors including cobicistat containing drugs,
Known contraindications to study treatments
Dermal fat grafting or complicated cavity;
Trial design
Design model
Crossover
Treatments tested in this trial
Hydrocortisone
Drug1 drops 4 times a day
Dexamethasone
Drug1 drops 4 times a day
Povidone
Other intervention1 drops 4 times a day
Treatment groups
30 Participants
are divided into 3 treatment groupsGroup A: HYDROCORTISONEExperimental treatment 1 intervention
Group B: DEXAMETHASONEExperimental treatment 1 intervention
Group C: POVIDONEPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Secretion Self-Rating Analog Scale score.
The overall score is analysed as the primary endpoint. Each sub-score is analysed independently in the secondary endpoints. This 40 point score is calculated as the sum of 4 criteria, each scored on 10 points. Analog scale from 1 to 10 on the frequency of secretions (from never to all the time) Analog scale from 1 to 10 on the colour of secretions (from clear to yellow) Analog scale from 1 to 10 on the quantity of secretions (from minimal to profuse) Analog scale from 1 to 10 on the viscosity of secretions (from liquid to very thick)
Time frame
Before first treatment period of 14 days2
Secretion Self-Rating Analog Scale score.
The overall score is analysed as the primary endpoint. Each sub-score is analysed independently in the secondary endpoints. This 40-point score is calculated as the sum of 4 criteria, each scored on 10 points. Analog scale from 1 to 10 on the frequency of secretions (from never to all the time) Analog scale from 1 to 10 on the colour of secretions (from clear to yellow) Analog scale from 1 to 10 on the quantity of secretions (from minimal to profuse) Analog scale from 1 to 10 on the viscosity of secretions (from liquid to very thick)
Time frame
After first treatment period of 14 days3
Secretion Self-Rating Analog Scale score.
The overall score is analysed as the primary endpoint. Each sub-score is analysed independently in the secondary endpoints. This 40-point score is calculated as the sum of 4 criteria, each scored on 10 points. Analog scale from 1 to 10 on the frequency of secretions (from never to all the time) Analog scale from 1 to 10 on the colour of secretions (from clear to yellow) Analog scale from 1 to 10 on the quantity of secretions (from minimal to profuse) Analog scale from 1 to 10 on the viscosity of secretions (from liquid to very thick)
Time frame
At 1.5 month (1 Month Wash-out after first treatment, and before second treatment)4
Secretion Self-Rating Analog Scale score.
The overall score is analysed as the primary endpoint. Each sub-score is analysed independently in the secondary endpoints. This 40-point score is calculated as the sum of 4 criteria, each scored on 10 points. Analog scale from 1 to 10 on the frequency of secretions (from never to all the time) Analog scale from 1 to 10 on the colour of secretions (from clear to yellow) Analog scale from 1 to 10 on the quantity of secretions (from minimal to profuse) Analog scale from 1 to 10 on the viscosity of secretions (from liquid to very thick)
Time frame
At 2 months (After second treatment period of 14 days)Secondary outcomes
1
Bulbar conjunctival inflammation score
Bulbar conjunctival inflammation score according to the grades of Saini et al. (Grade 1 to 3 : from normal to severe)
Time frame
At inclusion visit (basal)2
Bulbar conjunctival inflammation score
Bulbar conjunctival inflammation score according to the grades of Saini et al. (Grade 1 to 3 : from normal to severe)
Time frame
After first treatment period of 14 days3
Bulbar conjunctival inflammation score
Bulbar conjunctival inflammation score according to the grades of Saini et al. (Grade 1 to 3 : from normal to severe)
Time frame
At 2 months (After second treatment period of 14 days)4
Bulbar conjunctival inflammation score
Bulbar conjunctival inflammation score according to the grades of Saini et al. (Grade 1 to 3 : from normal to severe)
Time frame
At 3.5 months (After third treatment period of 14 days)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Agnes
Lead sponsor
Rennes University Hospital
Sponsor institution
Direction Générale de l'Offre de Soins
Collaborator
Laboratoires Thea
Collaborator
Source ClinicalTrials.gov