A Dose-Escalation Study to Assess the Safety and Tolerability of LX214 Ophthalmic Solution in Healthy Volunteers, Followed by an Open-Label Evaluation of LX214 in Patients With Keratoconjunctivitis Sicca (KCS)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00851734 |
Recruitment Status :
Completed
First Posted : February 26, 2009
Last Update Posted : June 22, 2012
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Keratoconjunctivitis Sicca | Drug: voclosporin ophthalmic solution | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 35 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1 Dose-Escalation Study To Assess the Safety and Tolerability of LX214 Ophthalmic Solution in Healthy Volunteers, Followed By an Open-Label Evaluation of LX214 Ophthalmic Solution in Patients With Keratoconjunctivitis Sicca |
Study Start Date : | February 2009 |
Actual Primary Completion Date : | March 2009 |
Actual Study Completion Date : | April 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: LX214 0.02%
LX214 ophthalmic solution 0.02%
|
Drug: voclosporin ophthalmic solution
0.02%, 0.2% t.i.d. or b.i.d. |
Experimental: LX214 0.2% |
Drug: voclosporin ophthalmic solution
0.02%, 0.2% t.i.d. or b.i.d. |
Placebo Comparator: placebo
placebo
|
Drug: voclosporin ophthalmic solution
0.02%, 0.2% t.i.d. or b.i.d. |
- ocular irritation [ Time Frame: 12 hours ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- No systemic disease as determined by a physical examination, clinical laboratory evaluation, and an ECG
- Schirmer's I Test ≥ 10mm/5 minutes with anesthesia
- Corrected Snellen acuity of 20/40 or better in both eyes
Exclusion Criteria:
- Subjects diagnosed with any ocular disease other than refraction error
- Subjects with intraocular pressure >21 mmHg
- Use of a contact lens within 7 days prior to administration of the first dose
- Subjects with history of ocular surgery
- Subjects with a history of laser refractive surgery

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00851734
United States, Pennsylvania | |
Product Investigations | |
Conshohocken, Pennsylvania, United States, 19428 |
Responsible Party: | Lux Biosciences, Inc. |
ClinicalTrials.gov Identifier: | NCT00851734 |
Other Study ID Numbers: |
LX214-01 |
First Posted: | February 26, 2009 Key Record Dates |
Last Update Posted: | June 22, 2012 |
Last Verified: | June 2012 |
Keratoconjunctivitis Keratoconjunctivitis Sicca Dry Eye Syndromes Conjunctivitis Conjunctival Diseases Eye Diseases |
Keratitis Corneal Diseases Lacrimal Apparatus Diseases Ophthalmic Solutions Pharmaceutical Solutions |