Who is sponsoring NCT03897712?

NCT03897712 is sponsored by Bausch & Lomb Incorporated.

What drugs are being tested in NCT03897712?

Interventions in NCT03897712: Custom Samfilcon B Contact Lenses, Alden Optical HP Sphere Contact Lens, ReNu MultiPlus Lubricating and Rewetting Drops, Biotrue Multi-Purpose Solution.

What condition does NCT03897712 study?

NCT03897712 studies Contact Lens Wear.

Is NCT03897712 still recruiting?

NCT03897712 is currently completed. Last updated 14 November 2022.

Are results published for NCT03897712?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-11-14 · How we verify

NCT03897712

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Evaluate the Safety and Effectiveness of a Silicone Hydrogel Custom Contact Lens When Compared to Alden Optical HP Sphere Lens

Completed NA Results posted Last updated 14 November 2022

What this trial tests

NA trial testing Custom Samfilcon B Contact Lenses in Contact Lens Wear in 84 participants. Completed in 28 August 2019.

Timeline

27 February 2019

Primary endpoint
28 August 2019

28 August 2019

Quick facts

Lead sponsor	Bausch & Lomb Incorporated
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	84
Start date	27 February 2019
Primary completion	28 August 2019
Estimated completion	28 August 2019
Sites	7 locations across United States

Drugs / interventions tested

Custom Samfilcon B Contact Lenses
Alden Optical HP Sphere Contact Lens
ReNu MultiPlus Lubricating and Rewetting Drops
Biotrue Multi-Purpose Solution

Conditions studied

Contact Lens Wear — all drugs for Contact Lens Wear →

Sponsor

Bausch & Lomb Incorporated — full company profile →

Who can join

Adults 18 to 40, any sex, with Contact Lens Wear. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Distance High-contrast logMAR Lens VA Primary · Month 3

Monocular distance high-contrast logarithm of the minimum angle of resolution (logMAR) lens visual acuity (VA) will be assessed at Week 1, Month 1, Month 2, and Month. For each eye LogMAR will be averaged at Week 1, Month 1, Month 2, and Month 3 visits, resulting in 1 value of "All Study" logMAR lens VA per eye.

Group	Value	95% CI
Custom Samfilcon B Contact Lenses	-0.057	± 0.0582
Alden Optical HP Sphere Contact Lenses	-0.059	± 0.0590

Proportion Of Eyes With Grade >2 Slit Lamp Findings Secondary · Month 3

Graded slit lamp findings will be assessed at Month 3. Each eye will be classified with respect to having 1 or more observations with Grade \>2 (Yes, No) at any visit. Criteria of each grade: 0=None, 1= Trace, 2= Mild, 3=Moderate, 4= Severe. Higher grades are worse outcomes.

Group	Value	95% CI
Custom Samfilcon B Contact Lenses	1
Alden Optical HP Sphere Contact Lenses	0

Sponsor's own description

This study is to evaluate the safety and efficacy of Bausch + Lomb custom samfilcon B (test) lens compared to the hioxifilcon D, 54% water, Alden Optical HP Sphere (control) lens when worn by participants who wear soft contact lens on a daily basis.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other Bausch & Lomb Incorporated trials

Trials by the same sponsor.

NCT07054606 — A Study to Evaluate Concomitant Perfluorohexyloctane Use With Contact Lens Wear · Phase 4 · completed
NCT06803654 — A Study Comparing the Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution 0.025% With Sodium Hyaluronate Rel · Phase 3 · completed
NCT06594185 — A Study to Evaluate Real World Outcomes of the enVista® Aspire (EA) and Aspire Toric (ETA) Intraocular Lens in Subjects · NA · completed
NCT06479148 — Clinical Evaluation of the Performance of the enVista® Aspire™ (EA) Lens · NA · terminated
NCT06333028 — A Study to Evaluate the enVista® Aspire (EA) Intraocular Lens in Subjects Undergoing Cataract Extraction · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03897712 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bausch & Lomb Incorporated
Last refreshed: 14 November 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03897712.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing