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NCT Number: NCT05668455

Comparison of Topical Treatment for Inflammatory Secretions of the Conjonctiva (Patients With Ocular Prostheses)

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.

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Key information

Conditions

Ocular Inflammation Ocular Prostheses

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centre Hospitalier Universitaire de Rennes _ Pontchaillou

Rennes, 35000, France

Location status: Recruiting

Location contact

Frederic MOURIAUX, MD

CONTACT

[email protected]

Yann MAUCOURANT, MD

CONTACT

[email protected]

About this study

There are more than 100,000 eye prosthesis wearers in France. Half of these patients are bothered by secretions or sandy sensations, or even chronic pain. Various anti-inflammatory treatments are proposed without scientific basis.

A pilot study on a limited number of patients conducted in 2017 at the University Hospital of Rennes and published in 2019 showed the interest of Dexamethasone eye drops in these patients. However, this study was retrospective and not controlled.

We therefore wish to propose a prospective, placebo-controlled, single-blind clinical study to define the value of anti-inflammatory treatment in patients with ocular prostheses.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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,
  • For women of childbearing age: effective contraception (effective contraception includes oral contraception, intrauterine devices and other forms of contraception with a failure rate <1%, for the duration of the study and up to 1 week after the last dose administered)
  • Have given free, informed and written consent.

Exclusion criteria

  • 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;
  • Gougerot-Sjögren syndrome;
  • Allergic conjunctivitis;
  • Damaged prosthesis;
  • Impossibility of carrying out the various tests required by the protocol for whatever reason (comprehension problems, motor disability);
  • Pregnant or breastfeeding woman;
  • Person already included in a RIPH1 research protocol with topical treatment of the cavity or systemic anti-inflammatory treatment and/or who could lead to a bias in the present study
  • Person under legal protection (safeguard of justice, curatorship, guardianship) or person deprived of liberty.

Treatment and study plan

Hydrocortisone

Drug

1 drops 4 times a day

Dexamethasone

Drug

1 drops 4 times a day

Povidone

Other

1 drops 4 times a day

Primary outcomes

  1. Secretion Self-Rating Analog Scale score.

    Time frame: Before first treatment period of 14 days

    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)

  2. Secretion Self-Rating Analog Scale score.

    Time frame: After first treatment period of 14 days

    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)

  3. Secretion Self-Rating Analog Scale score.

    Time frame: At 1.5 month (1 Month Wash-out after first treatment, and before second treatment)

    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)

  4. Secretion Self-Rating Analog Scale score.

    Time frame: At 2 months (After second treatment period of 14 days)

    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)

  5. Secretion Self-Rating Analog Scale score.

    Time frame: At 3 months (1 Month Wash-out after second treatment, and before third treatment)

    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)

  6. Secretion Self-Rating Analog Scale score.

    Time frame: At 3.5 months (After third treatment period of 14 days)

    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)

Secondary outcomes

  1. Bulbar conjunctival inflammation score

    Time frame: At inclusion visit (basal)

    Bulbar conjunctival inflammation score according to the grades of Saini et al. (Grade 1 to 3 : from normal to severe)

  2. Bulbar conjunctival inflammation score

    Time frame: After first treatment period of 14 days

    Bulbar conjunctival inflammation score according to the grades of Saini et al. (Grade 1 to 3 : from normal to severe)

  3. Bulbar conjunctival inflammation score

    Time frame: At 2 months (After second treatment period of 14 days)

    Bulbar conjunctival inflammation score according to the grades of Saini et al. (Grade 1 to 3 : from normal to severe)

  4. Bulbar conjunctival inflammation score

    Time frame: At 3.5 months (After third treatment period of 14 days)

    Bulbar conjunctival inflammation score according to the grades of Saini et al. (Grade 1 to 3 : from normal to severe)

  5. Tarsal conjunctival inflammation score according

    Time frame: At inclusion visit (basal)

    Tarsal conjunctival inflammation score according to the grades of Saini et al.(Grade 1 to 4 : from absent to more than one millimetre in diameter)

  6. Tarsal conjunctival inflammation score according

    Time frame: After first treatment period of 14 days

    Tarsal conjunctival inflammation score according to the grades of Saini et al.(Grade 1 to 4 : from absent to more than one millimetre in diameter)

  7. Tarsal conjunctival inflammation score according

    Time frame: At 2 months (After second treatment period of 14 days)

    Tarsal conjunctival inflammation score according to the grades of Saini et al.(Grade 1 to 4 : from absent to more than one millimetre in diameter)

  8. Tarsal conjunctival inflammation score according

    Time frame: At 3.5 months (After third treatment period of 14 days)

    Tarsal conjunctival inflammation score according to the grades of Saini et al.(Grade 1 to 4 : from absent to more than one millimetre in diameter)

  9. Secretion frequency

    Time frame: Before first treatment period of 14 days

    Analog scale from 1 to 10 on the frequency of secretions (from never to all the time) according to the secretion analysis scale (Jacobs et al.)

  10. Secretion frequency

    Time frame: After first treatment period of 14 days

    Analog scale from 1 to 10 on the frequency of secretions (from never to all the time) according to the secretion analysis scale (Jacobs et al.)

  11. Secretion frequency

    Time frame: At 1.5 month (Before second treatment period of 14 days

    Analog scale from 1 to 10 on the frequency of secretions (from never to all the time) according to the secretion analysis scale (Jacobs et al.)

  12. Secretion frequency

    Time frame: At 2 months (After second treatment period of 14 days

    Analog scale from 1 to 10 on the frequency of secretions (from never to all the time) according to the secretion analysis scale (Jacobs et al.)

  13. Secretion frequency

    Time frame: At 3 months (Before third treatment period of 14 days)

    Analog scale from 1 to 10 on the frequency of secretions (from never to all the time) according to the secretion analysis scale (Jacobs et al.)

  14. Secretion frequency

    Time frame: At 3.5 months (After third treatment period of 14 days)

    Analog scale from 1 to 10 on the frequency of secretions (from never to all the time) according to the secretion analysis scale (Jacobs et al.)

  15. Colour of secretions

    Time frame: Before first treatment period of 14 days

    Analog scale from 1 to 10 on the colour of secretions (from clear to yellow) according to the secretion analysis scale (Jacobs et al.)

  16. Colour of secretions

    Time frame: After first treatment period of 14 days

    Analog scale from 1 to 10 on the colour of secretions (from clear to yellow) according to the secretion analysis scale (Jacobs et al.)

  17. Colour of secretions

    Time frame: At 1.5 month (Before second treatment period of 14 days)

    Analog scale from 1 to 10 on the colour of secretions (from clear to yellow) according to the secretion analysis scale (Jacobs et al.)

  18. Colour of secretions

    Time frame: At 2 months (After second treatment period of 14 days

    Analog scale from 1 to 10 on the colour of secretions (from clear to yellow) according to the secretion analysis scale (Jacobs et al.)

  19. Colour of secretions

    Time frame: At 3 months (Before third treatment period of 14 days)

    Analog scale from 1 to 10 on the colour of secretions (from clear to yellow) according to the secretion analysis scale (Jacobs et al.)

  20. Colour of secretions

    Time frame: At 3.5 months (After third treatment period of 14 days)

    Analog scale from 1 to 10 on the colour of secretions (from clear to yellow) according to the secretion analysis scale (Jacobs et al.)

  21. Amount of secretions

    Time frame: Before first treatment period of 14 days

    Analog scale from 1 to 10 on the quantity of secretions (from minimal to profuse) according to the secretion analysis scale (Jacobs et al.)

  22. Amount of secretions

    Time frame: After first treatment period of 14 days

    Analog scale from 1 to 10 on the quantity of secretions (from minimal to profuse) according to the secretion analysis scale (Jacobs et al.)

  23. Amount of secretions

    Time frame: At 1.5 month (Before second treatment period of 14 days)

    Analog scale from 1 to 10 on the quantity of secretions (from minimal to profuse) according to the secretion analysis scale (Jacobs et al.)

  24. Amount of secretions

    Time frame: At 2 months (After second treatment period of 14 days

    Analog scale from 1 to 10 on the quantity of secretions (from minimal to profuse) according to the secretion analysis scale (Jacobs et al.)

  25. Amount of secretions

    Time frame: At 3 months (Before third treatment period of 14 days

    Analog scale from 1 to 10 on the quantity of secretions (from minimal to profuse) according to the secretion analysis scale (Jacobs et al.)

  26. Amount of secretions

    Time frame: At 3.5 months (After third treatment period of 14 days)

    Analog scale from 1 to 10 on the quantity of secretions (from minimal to profuse) according to the secretion analysis scale (Jacobs et al.)

  27. Thickness/Viscosity of secretions

    Time frame: Before first treatment period of 14 days

    Analog scale from 1 to 10 on the viscosity of secretions (from liquid to very thick) to the secretion analysis scale (Jacobs et al.)

  28. Thickness/Viscosity of secretions

    Time frame: After first treatment period of 14 days

    Analog scale from 1 to 10 on the viscosity of secretions (from liquid to very thick) to the secretion analysis scale (Jacobs et al.)

  29. Thickness/Viscosity of secretions

    Time frame: At 1.5 month (Before second treatment period of 14 days)

    Analog scale from 1 to 10 on the viscosity of secretions (from liquid to very thick) to the secretion analysis scale (Jacobs et al.)

  30. Thickness/Viscosity of secretions

    Time frame: At 2 months (After second treatment period of 14 days

    Analog scale from 1 to 10 on the viscosity of secretions (from liquid to very thick) to the secretion analysis scale (Jacobs et al.)

  31. Thickness/Viscosity of secretions

    Time frame: At 3 months (Before third treatment period of 14 days)

    Analog scale from 1 to 10 on the viscosity of secretions (from liquid to very thick) to the secretion analysis scale (Jacobs et al.)

  32. Thickness/Viscosity of secretions

    Time frame: At 3.5 months (After third treatment period of 14 days)

    Analog scale from 1 to 10 on the viscosity of secretions (from liquid to very thick) to the secretion analysis scale (Jacobs et al.)

  33. OSDI quality of life score adapted to prosthesis wearers

    Time frame: Before first treatment period of 14 days

    OSDI quality of life score adapted to prosthesis wearers, scored on 40 points (10 items with a maximum of 4 points per item) (Maucourant et al.)

  34. OSDI quality of life score adapted to prosthesis wearers

    Time frame: After first treatment period of 14 days

    OSDI quality of life score adapted to prosthesis wearers, scored on 40 points (10 items with a maximum of 4 points per item) (Maucourant et al.)

  35. OSDI quality of life score adapted to prosthesis wearers

    Time frame: At 1.5 month (Before second treatment period of 14 days)

    OSDI quality of life score adapted to prosthesis wearers, scored on 40 points (10 items with a maximum of 4 points per item) (Maucourant et al.)

  36. OSDI quality of life score adapted to prosthesis wearers

    Time frame: At 2 months (After second treatment period of 14 days

    OSDI quality of life score adapted to prosthesis wearers, scored on 40 points (10 items with a maximum of 4 points per item) (Maucourant et al.)

  37. OSDI quality of life score adapted to prosthesis wearers

    Time frame: At 3 months (Before third treatment period of 14 days)

    OSDI quality of life score adapted to prosthesis wearers, scored on 40 points (10 items with a maximum of 4 points per item) (Maucourant et al.)

  38. OSDI quality of life score adapted to prosthesis wearers

    Time frame: At 3.5 months (After third treatment period of 14 days)

    OSDI quality of life score adapted to prosthesis wearers, scored on 40 points (10 items with a maximum of 4 points per item) (Maucourant et al.)

Sponsors and collaborators

Lead sponsor

Agnes

Other

Collaborators

  • Direction Générale de l'Offre de Soins
  • Laboratoires Thea

Registry information

Official study title

Comparison of Topical Hydrocortisone Versus Dexamethasone Treatment for Inflammatory Secretions of the Conjonctiva in Patients With Ocular Prostheses

Acronym: CRYSTAL

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Dec 29, 2022
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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