Trials / Completed
CompletedNCT03517748
Evaluation of the Efficacy and Safety of DM05 Versus Optive™ on the Treatment of Moderate to Severe Ocular Dryness
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 80 (actual)
- Sponsor
- Horus Pharma · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Evaluation of the non-inferiority of DM05 in comparison with OptiveTM, in terms of cornea and conjunctiva staining (Oxford score), on worse eye, between D0 and D35. * Comparison of D35 versus D0 and D84 versus D0 for each product and comparison between products for the following parameters: * Evolution of cornea and conjunctiva staining (Oxford score) on worse eye. * Evolution of OSDI score (Ocular Surface Disease Index). * Evolution of Van Bijsterveld score (Lissamine green staining) in worse eye. * Evolution of Schirmer test result in worse eye. * Evolution of Tear film Break-Up Time (TBUT) in worse eye. * Evolution of ocular dryness severity by evaluation of each main symptom by the patient and total score of all symptoms * Evaluation of treatment performance by the investigator and the patient. * Evaluation of the average frequency of use during 84 days for DM05 and OptiveTM. Selection visit: D-14 to D-7 Wash-out period: 1 to 2 weeks with preservative-free 0.9% NaCl at 3 drops per day (Hydrabak®): D0 : inclusion visit Follow-up visits: D35, D84
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | DM05 eye drops | Ophthalmic use. One to two drops instilled in each eye from 4 to 6 times per day during 84 days of treatment. |
| DEVICE | Optive™ eye drops | Ophthalmic use. One to two drops instilled in each eye from 4 to 6 times per day during 84 days of treatment. |
Timeline
- Start date
- 2016-12-01
- Primary completion
- 2018-01-02
- Completion
- 2018-03-30
- First posted
- 2018-05-07
- Last updated
- 2018-05-07
Source: ClinicalTrials.gov record NCT03517748. Inclusion in this directory is not an endorsement.