Evaluation of the Efficacy and Safety of DM05 Versus Optive™ on the Treatment of Moderate to Severe Ocular Dryness

NCT03517748 | Completed DMC

• 2 other identifiers: 15E11222016-A01843-48
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a multicentric, comparative, randomized, investigator-blinded, in parallel groups study to demonstrate the non-inferiority of DM05 in comparison with Optive™, in terms of cornea and conjunctiva staining (Oxford score) on patients with moderate to severe ocular dryness, after 35 days of treatment.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• Demonstrate the non-inferiority of DM05 in comparison with OptiveTM, in terms of cornea and conjunctiva staining (Oxford score) on patients with moderate to severe ocular dryness, after 35 days of treatment.

  Assess the ocular surface fluorescein staining score- mean change from Baseline in the study at D35 in ocular surface fluorescein stainig score according to a scale from zero to 15

  35 days

Secondary Outcomes (15)

• To assess the total ocular surface fluorescein staining score at D84

  0 and 84 days

• Evolution of DEQ-5 score

  35 days

• Evolution of DEQ-5 score

  84 days

• Evolution of Van Bijterveld score ( lissamine green staining)

  35 Days

• Evolution of Van Bijterveld score ( lissamine green staining)

  84 days

Study Arms (2)

the investigational device: DM05

EXPERIMENTAL

DM05 eye drops, multidose sterile emulsion, will be administered in the DM05 Arm at one to two drops instilled in each eye from 4 to 6 times per day during 84 days

Device: DM05 eye drops

The comparative device : Optive™

ACTIVE COMPARATOR

Optive™ eye drops, multidose sterile solution, will be administered in the Optive Arm at one to two drops instilled in each eye from 4 to 6 times per day during 84 days

Device: Optive™ eye drops

Interventions

DM05 eye drops DEVICE

Ophthalmic use. One to two drops instilled in each eye from 4 to 6 times per day during 84 days of treatment.

the investigational device: DM05

Optive™ eye drops DEVICE

Ophthalmic use. One to two drops instilled in each eye from 4 to 6 times per day during 84 days of treatment.

The comparative device : Optive™

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sex: male or female.
• Age: more than 18 years.
• Diagnosis of moderate to severe ocular dryness defined by a score OSDI (Ocular Surface Disease Index) ≥18.
• Subject with at least one eye with:
• Global ocular staining (cornea and conjunctiva) ≥4 and ≤9 (Oxford scale from 0 to 15)
• AND one the following criteria:
• Schirmer test ≥ 3mm/5 min and ≤9mm/ 5 min OR
• Sum of 3 measurements of Tear film Break-Up Time (TBUT) ≤ 30s.
• Subject, having given freely and expressly his/her informed consent.
• Subject who is able to comply with the study requirements, as defined in the present protocol, at the Investigator's appreciation.
• In France: subject being affiliated to a health social security system.
• Female subjects of childbearing potential should use a medically accepted contraceptive regimen since at least 12 weeks before the beginning of the study, during all the study and at least 1 month after the study end.

You may not qualify if:

• Pregnant or nursing woman or planning a pregnancy during the study.
• Subject deprived of freedom by administrative or legal decision.
• Subject in a social or sanitary establishment.
• Major subject who is under guardianship or who is not able to express his consent.
• Subject suspected to be non-compliant according to the Investigator's judgment.
• Subject wearing contact lenses during the study.
• Far best corrected visual acuity \< 1/10
• Subject with severe ocular dryness with one of these conditions:
• Eyelid or blinking malfunction
• Corneal disorders not related to dry eye syndrome
• Ocular metaplasia
• Filamentous keratitis
• Corneal neovascularization
• Subject with severe meibomian gland dysfunction (MGD)
• Within the last 12 months, history of ocular allergy or ocular herpes.

Sponsors & Collaborators

• Horus Pharma: lead

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Christophe Baudouin, Pr

  Hopital d Ophtalmologie des Quinze-vingts

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Because the comparator will be in commercial packaging, the blinding of the subject is not possible. However, the study will be blinded for the investigator: evaluations will be done by an independent investigator, different than the person who will distribute the product. Subjects will be identified by a patient number. Each patient number will be associated to a treatment number, according to a randomization list provided before the beginning of the clinical investigation, and randomized either in one of both treatment groups (DM05 or Optive®).

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: May 7, 2018
• Study Start: December 1, 2016
• Primary Completion: January 2, 2018
• Study Completion: March 30, 2018
• Last Updated: May 7, 2018

Record last verified: 2018-05